Inflammatory Lesion Counts Research Articles

Efficacy of a new generation topical retinoid in the treatment of patients with moderate to severe acne on the face and trunk

BACKGROUND: The extreme prevalence of acne, long-term course and multifactorial pathogenesis necessitate the development of new drugs and treatment methods aimed at increasing efficiency and achieving clinical effects in the shortest possible time. This article presents data from two international clinical studies to determine the effectiveness and safety of trifarotene 50 µg/g (0.005%) cream in the treatment of patients with moderate acne on the face and trunk. AIM: To evaluate the safety and effectiveness of trifarotene cream, 0.005%, a new topical retinoid, for moderate acne of the face and trunk. MATERIALS AND METHODS: Two international, double-blind, randomized, placebo (vehicle) controlled, 12-week phase III studies screened 2817 and randomized 2420 patients 9 years of age and over. The effectiveness of the drug was assessed based on the registration of the number of patients who achieved the effect of "clear" or "almost clear" skin condition and an improvement of ≥2 points in terms of IGA on the facial skin and PGA on the truncal skin during 12 weeks of treatment, as well as by calculating the change in absolute number of inflammatory and non-inflammatory acne elements relatively to the initial level. The safety of therapy was assessed based on the registration of adverse events, local tolerability (the formation and severity of retinoic dermatitis), abnormalities in vital signs and the results of standard laboratory tests. RESULTS: The onset of effect of trifarotene versus that of its vehicle was rapid, with significant reductions in both inflammatory and noninflammatory lesion counts seen as early as 1 week after treatment on the face and as early as 2 weeks after treatment on the trunk. In both studies, at week 12 the facial success rates according to IGA and PGA and change in inflammatory and noninflammatory lesion counts (both absolute and percentage) were all highly significant (p 0.001) in favor of trifarotene when compared with the vehicle and the formation of the “almost clear” and “clean” effect was registered in the vast majority of patients, who used cream with 0.005% trifarotene. CONCLUSION: The results of the study demonstrated the pronounced clinical effectiveness of trifarotene cream 0.005% in the treatment of patients with moderate acne on the skin of the face and trunk.

Investigation of the effect of adapalene 0.3%/benzoyl peroxide 2.5% gel in Korean patients with acne: a randomized, double-blind clinical trial, with a histopathological and immunohistochemical study.

Acne vulgaris poses significant physical and psychological challenges worldwide. Data of adapalene 0.3%/benzoyl peroxide 2.5% gel (A0.3/BPO2.5) for acne treatment in Asian patients is limited. In this randomized double-blind clinical trial, 49 Korean patients with moderate-to-severe acne and scars were assigned to the A0.3/BPO2.5 (N.=37) or vehicle (N.=12) group. Acne and acne scar severity scores were assessed at baseline and 4, 8, 12, and 24 weeks. The primary outcomes were treatment success rate (reduction of ≥2 Investigator's Global Assessment grade and reaching a grade of 0 or 1) and proportional acne lesion and scar count reduction against the baseline. To assess histological changes, 2-mm punch biopsies were performed at baseline and week 24 on the respective inflammatory lesions or scars. At week 24, the A0.3/BPO2.5 group had a significantly higher treatment success rate than the vehicle group. The total acne count, inflammatory lesion count, and non-inflammatory lesion count percentages (against baselines) with A0.3/BPO2.5 and the vehicle were 12.1% vs. 96.7%, 8.0% vs. 101.2%, and 13.3% vs. 98.9%, respectively (all P<0.001). Scar count percentages (against baselines) with A0.3/BPO2.5 and the vehicle were 27.3% and 96.5%, respectively (P<0.001). Significant elevations in collagen 1 and 3, elastin, CK15, and p63 levels, with increases of 172.7%, 230.6%, 176.5%, 286.2%, and 105.9%, respectively, in comparison to baseline (all P<0.05). No major adverse events leading to discontinuation were observed. A0.3/BPO2.5 was an effective and safe treatment for acne and acne scars in Asian patients supported by robust histopathological and immunohistochemical evidence.

Comparative study on efficacy of benzoyl peroxide with adapalene versus plain adapalene in the treatment of acne vulgaris

BACKGROUND Acne vulgaris is a dermatological disorder of pilosebaceous unit, characterized by formation of comedones and inflammatory lesions. It is one of the most common skin manifestations among adolescents, also affecting the adult population. The treatment of acne basically involves reduction of lesions and prevention of permanent scarring. The current line of treatment for mild to moderate acne is topical medications with antimicrobials and retinoids. The present study assessed the efficacy of combination of adapalene and benzoyl peroxide in comparison to adapalene for topical treatment of mild to moderate acne vulgaris. OBJECTIVE The purpose of the study was to compare the clinical efficacy of topical adapalene and topical adapalene with benzoyl peroxide in treatment of mild to moderate cases of acne vulgaris. METHODOLOGY A prospective, comparative study was carried out among 84 patients with mild and moderate acne vulgaris visiting the Department of Dermatology, Kathmandu Medical College and Teaching Hospital, Bhaktapur, Nepal from December 2019 till March 2021. The patients fulfilling the inclusion criteria were divided into two groups. Group A received topical adapalene whereas Group B received topical adapalene with benzoyl peroxide. The efficacy of treatment in both groups were determined based on the reduction of total lesion count. Both inflammatory and non-inflammatory lesions were counted at 4th week, 8th week and 12th week. RESULTS All patients were assessed according to Global Acne Grading System (GAGS) and grouped as mild and moderate. The most frequent age group affected by acne vulgaris was 18-22 years. The mean age was 22.15 ± 5.315. Females (64.30%) were affected more commonly than males (35.7%). Majority of patients presented with moderate or inflammatory acne lesions. The face (90.5%) was most commonly affected site by acne vulgaris. The number of patients enrolled in the study were 84 out of which 63 (75%) completed the study. It was found that the reduction of non-inflammatory, inflammatory and total lesion count from the baseline were highly significant in between and both the group (P&lt;0.001). A total of 52.4% had very good result of the treatment, 44.4% of them had good result and remaining 3.2% of the patients’ result was fair. However, the efficacy of benzoyl peroxide with adapalene was found to be better than adapalene alone. CONCLUSIONThis study concluded that topical benzoyl peroxide with adapalene is more efficacious to treat mild to moderate acne vulgaris.

Challenges in designing a randomized, double-blind noninferiority trial for treatment of acne: The SD-ACNE trial.

Excessive use of antibiotics has led to development of antibiotic resistance and other antibiotic-associated complications. Dermatologists prescribe more antibiotics per clinician than any other major specialty, with much of this use for acne. Alternative acne treatments are available but are used much less often than antibiotics, at least partially because dermatologists feel that they are less effective. Spironolactone, a hormonal therapy with antiandrogen effects that can address the hormonal pathogenesis of acne, may represent a therapeutic alternative to oral antibiotics for women with acne. However, the comparative effects of spironolactone and oral antibiotics in the treatment of acne have not been definitively studied. The Spironolactone versus Doxycycline for Acne: A Comparative Effectiveness, Noninferiority Evaluation (SD-ACNE) trial aims to answer whether spironolactone, in addition to standard topical therapy, is noninferior to doxycycline (an oral antibiotic) for women with acne. Several interesting challenges arose in the development of this study, including determining acceptability of the comparative regimens to participating dermatologists, identifying data to support a noninferiority margin, and establishing a process for unblinding participants after they completed the study while maintaining the blind for study investigators. We present the scientific and clinical rationale for the decisions made in the design of the trial, including input from key stakeholders through a Delphi consensus process. The Spironolactone versus Doxycycline for Acne: A Comparative Effectiveness, Noninferiority Evaluation trial (NCT04582383) is being conducted at a range of community and academic sites in the United States. To maximize external validity and inform clinical practice, the study is designed with broad eligibility criteria and no prohibition of use of topical medications. Participants in the trial will be randomized to receive either spironolactone 100 mg/day or doxycycline hyclate 100 mg/day for 16 weeks. The primary outcome is the absolute decrease in inflammatory lesion count, and we have established a noninferiority margin of four inflammatory lesions. Secondary outcomes include the percentage of participants achieving Investigator Global Assessment success, change in quality of life, and microbiome changes and diversity. The Spironolactone versus Doxycycline for Acne: A Comparative Effectiveness, Noninferiority Evaluation trial will have substantial implications for the treatment of acne and antibiotic stewardship. In addition, this study will provide important information on the effect of these systemic agents on the development of changes to the microbiome and antibiotic resistance in a healthy population of patients.

A dermocosmetic regimen is effective and safe for mild to moderate acne in subjects of all skin phototypes

AbstractBackgroundAcne vulgaris is a chronic inflammatory skin condition with a multifactorial pathogenesis. The clinical appearance of acne and its sequelae may differ according to phototypes. Data regarding the potential benefit of dermocosmetics (DC) regardless of phototype are lacking and assessing acne improvement can be difficult, given the lack of visual support in people with skin of colour. A DC regimen, combining a cleanser and a cream, both containing thermal spring water, has been developed for the management of mild‐to‐moderate acne, for all skin phototypes studied.ObjectivesTo assess the efficacy and local tolerance of a DC routine in mild‐to‐moderate acne and to visualize the clinical improvement in all skin phototypes.MethodsIn an open‐labelled, multicentre clinical study, subjects of any phototype aged above 11 years and above with mild (N = 48, 55.2%) or moderate (N = 39, 44.8%) facial acne applied the DC twice daily for 56 days. No other acne care was allowed. Acne severity, as well as inflammatory and noninflammatory lesion counts, were assessed at baseline, Days 28 and 56. Photographs were taken using a novel imaging tool based on multimodal acquisition, to show clinical improvement over time.ResultsEighty‐seven subjects, 41 adults and 46 adolescents, were included; 59.8% were female and were aged between 11 and 44 years. The total acne lesion count decreased by 34%, the noninflammatory lesion count by 28%, and the inflammatory lesion count by 52% at Day 56. All % changes were statistically significant (p &lt; 0.05). The GEA score decreased, with 25% of subjects showing at least a one‐grade improvement at Day 28 and 59% at Day 56. Local tolerance was excellent.ConclusionsThe tested DC care is beneficial for the improvement of acne and is very well tolerated in all skin phototypes studied.

Efficacy and Safety of Micronized Isotretinoin Administered Once Daily Without Food in Patients With Recalcitrant Nodular Acne.

Micronized isotretinoin 0.4 to 0.8 mg/kg/day administered in 2 divided doses with or without meals is approved for the treatment of severe nodular acne in patients aged 12 years or older. Although practitioners may suggest once-daily dosing to increase patient compliance, supporting data are limited. In this pilot study, patients aged 12 years or older with severe nodular acne (Investigator's Global Assessment [IGA] =&gt;4 and &gt;5 facial nodules) received once-daily micronized isotretinoin 0.4 to 0.8 mg/kg/day without food for 20 weeks. The coprimary efficacy endpoints were changes from baseline in nodular lesion count (NLC) and percentage of patients with a =&gt;90% reduction in NLC at week 24. Secondary endpoints included percentage of patients achieving IGA 0/1; reductions in inflammatory lesion count (ILC) and noninflammatory lesion count (NILC); adverse events (AEs); and severity of erythema, dryness, peeling, oiliness, burning, and pruritus. Analyses included all enrolled patients with the last observation carried forward. Twenty-two of 24 patients completed the study. From baseline to week 24, NLC decreased by a median (quartile [Q]1, Q3) of 6 (5, 7), all patients experienced complete clearance of nodules, 23/24 (96%) patients achieved IGA 0/1, and ILC and NILC decreased by a mean +/- standard deviation of 97.8% +/- 5.7% and 98.4% +/-&nbsp;6.2%, respectively (all P&lt;0.0001). There were small, significant, early increases in the severity of erythema, dryness, and peeling; 2 patients experienced 3 AEs considered unrelated to treatment. Once-daily micronized isotretinoin administered without food was efficacious and well tolerated in patients with severe nodular acne.&nbsp; J Drugs Dermatol. 2024;23(6):423-428.&nbsp; &nbsp;&nbsp; doi:10.36849/JDD.7863.

Comparison of the Efficacy of Clascoterone, Trifarotene, and Tazarotene for the Treatment of Acne: A Systematic Literature Review and Meta-Analysis.

Acne vulgaris, a chronic inflammatory condition, is associated with significant physical and psychosocial burden. Since 2019, three new topical agents for acne vulgaris have been approved in the USA and Canada. We performed a systematic review and meta-analysis to compare the efficacy between twice-daily clascoterone cream 1%, once-daily trifarotene 0.005% cream, and once-daily tazarotene 0.045% lotion for acne treatment. Randomized controlled trials (RCTs) comparing clascoterone, trifarotene, or tazarotene with vehicle in patients with moderate-to-severe acne were identified from a systematic literature review and included in a meta-analysis. Primary outcomes were percentage reduction in inflammatory and noninflammatory lesion count (ILC and NILC, respectively) and treatment success rate (≥ 2-grade improvement in Investigator's Global Assessment or Evaluator's Global Severity Score and a rating of clear or almost clear) at week 12. DerSimonian and Laird random-effects models with the inverse variance method were used to calculate the mean difference (MD) for percentage reduction in ILC and NILC, and odds ratios (ORs) for the rate of treatment success. Six Phase 3 RCTs were included in the meta-analysis. The analyses showed robust differences favoring the interventions for ILC (MD: - 11.5; 95% confidence interval [CI]: - 14.39, - 8.62), NILC (MD: - 12.25; 95% CI: - 15.21, - 9.29), and treatment success rate (OR: 2.14; 95% CI: 1.81, 2.53). No differences were observed between clascoterone, trifarotene, and tazarotene for ILC (MD: - 12.8, - 11.2, and - 10.1, respectively), NILC (MD: - 11.6, - 13.9, and - 12.8, respectively), or treatment success rate (OR: 2.9, 1.9, and 2.1, respectively (all P > 0.05). No significant differences in efficacy were observed between clascoterone, trifarotene, and tazarotene after 12weeks of treatment in patients with moderate-to-severe acne. Differences in application frequency and safety profile should also be taken into consideration when making treatment decisions.

Efficacy of Low-Level Laser Versus Topical Erythromycin 2% in the Treatment of Inflammatory Acne Vulgaris.

Acne vulgaris is a skin problem affecting many people of different ages. Despite many options that are available for treatment of acne vulgaris, many patients still respond inadequately to treatment. Phototherapy is one of the best acne treatment options. It was to compare the efficacy of low-level laser therapy in treatment of inflammatory acne versus topical erythromycin 2% cream. This study included 40 patients (18 males, 22 females) with different clinical severities of acne vulgaris. All the participants underwent split-face treatment: one side with 8 treatments (twice per week) of a low-level continuous infrared diode laser (808 nm) wavelength and (500 Hz) frequency and the other side with topical erythromycin 2% twice daily (aknemycin cream 2%). Evaluation was done at start of sessions, 2 weeks after the end of sessions and 3 months after stoppage of treatment depending on: photographs, global evaluation of acne scale, and Indian acne association grading. There was improvement of acne lesions on laser side and antibiotic side (assessed as non-inflammatory and inflammatory lesion counts). Laser side showed better results than antibiotic side. Patients were more satisfied with laser treatment due to minimal side effects and less relapse. A series of 8 treatments using low level continuous infrared diode laser represents a cheap, safe and effective non-invasive therapeutic option for acne vulgaris.

Efficacy and Safety of Fixed-Dose Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne Vulgaris in Children and Adolescents

Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose triple-combination formulation approved for acne vulgaris and is indicated for use in patients aged 12 years and older. As topical acne treatment in pediatric patients may be complicated by tolerability issues and/or a perceived lack of efficacy, the objective of this post hoc analysis was to investigate the efficacy and safety of CAB in children and adolescents.&#x0D; Methods: Data were pooled from two phase 3 double-blind, randomized, 12-week studies (NCT04214639; NCT04214652). Eligible participants ≥9 years of age with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. This analysis evaluated adolescents aged 12-17 years (CAB: n=123; vehicle: n=50). Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success), least-squares mean percent change from baseline in inflammatory/noninflammatory lesions, and treatment-emergent adverse events (TEAEs). Descriptive efficacy and safety data for five children aged 10-11 years enrolled in the study are also summarized (CAB: n=3; vehicle: n=2).&#x0D; Results: At week 12, 51.5% of CAB–treated participants aged ≥12 years achieved treatment success vs 24.9% with vehicle gel (P&lt;0.01). CAB treatment resulted in significant reductions of &gt;70% in inflammatory and noninflammatory lesion counts in adolescents (78.3% and 73.7%, respectively) vs vehicle (50.5% and 42.9%; P&lt;0.001, both). Most TEAEs were of mild-to-moderate severity, and the most common (&gt;3% in any treatment) treatment-related TEAE was application site pain. Less than 2.5% of participants withdrew due to AEs. For the 5 children aged &lt;12 years, all 3 treated with CAB achieved treatment success, with reductions in inflammatory/noninflammatory lesions ranging from 76%-100%; neither vehicle-treated participant achieved treatment success. Only one CAB–treated younger participant experienced TEAEs (application site pain/dryness, and erythema [all mild/moderate]) and none discontinued the study.&#x0D; Conclusions: In two pooled phase 3 studies, once-daily CAB gel—the first approved fixed-dose, triple-combination topical formulation for acne vulgaris—was well tolerated and efficacious in pediatric participants with moderate-to-severe acne, with over half achieving treatment success at week 12.&#x0D; Funding: Ortho Dermatologics

Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Females with Moderate to Severe Acne: Post Hoc Analysis by Age

Introduction: While acne is common in adolescents, the overall prevalence in adults is increasing, especially among females. In addition, acne in older females is associated with greater negative impacts on quality of life. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% (CAB) gel—the first fixed-dose, triple-combination topical product approved for acne—has demonstrated good efficacy, safety, and tolerability in participants with moderate-to-severe acne. The objective of this analysis is to assess the impact of age on efficacy, safety, and tolerability in females with moderate-to-severe acne.&#x0D; Methods: In one phase 2 (N=741; NCT03170388) and two identically designed phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, randomized, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized to receive once-daily CAB or vehicle gel; the phase 2 study included three additional dyad randomization arms (data not shown). Coprimary endpoints comprised inflammatory and noninflammatory lesion counts and treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and score of ‘clear’ or ‘almost clear’). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were also assessed. Pooled data from these studies were analyzed post hoc from female participants categorized by age: 9-24 years (n=274) and ≥25 years (n=121).&#x0D; Results: At week 12 in both age groups, least-squares mean percent reductions from baseline were &gt;70% in CAB-treated females versus vehicle gel for inflammatory (9-24 y: 77.8% vs 53.8%; ≥25 y: 77.8% vs 60.5%; P&lt;0.01, both) and noninflammatory lesions (9-24 y: 72.8% vs 44.5%; ≥25 y: 73.7% vs 55.2%; P&lt;0.001, both). Half of CAB-treated females in both age groups achieved treatment success at week 12 versus less than one-quarter with vehicle (9-24 y: 54.1% vs 15.6%; ≥25 y: 50.1% vs 22.5%; P&lt;0.01, both). Most TEAEs were mild-to-moderate in severity, with rates similar to the overall pooled phase 2 and 3 populations. Although there were transient increases in the severity of cutaneous safety/tolerability assessments with CAB, scores generally returned to or near baseline levels for most assessments by week 12 in younger and older females. No notable age-related trends in safety were observed.&#x0D; Conclusions: With greater than 70% lesion reductions and half of participants achieving treatment success by week 12, the innovative, fixed-dose triple combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel demonstrated good efficacy, safety, and tolerability in both younger and older females with moderate-to-severe acne.&#x0D; Funding: Ortho Dermatologics

Twelve Week Study Evaluating the Efficacy of a Novel Standardized Nutraceutical to Improve Acne and Skin Health

INTRODUCTION&#x0D; Although acne is generally viewed as the result of a localized immune response at the pilosebaceous unit, it is a condition with multifactorial etiology. While conventional treatments have focused primarily on the four major pathogenic factors, nutraceuticals offer an alternative or complementary approach to address more systemic, intertwined mechanisms involved in acne pathogenesis. These include stress, diet and metabolism, skin and gut microbiome, hormonal fluctuations, oxidative stress, and immune function. Therapies which target these underlying mechanisms have gone largely unexplored as ways to address acne. Here, we present the results of a novel nutraceutical addressing these root causes in patients with non-cystic acne. &#x0D; DESIGN&#x0D; This was a 12-week single-arm prospective study for adults aged 18-50 with facial non-cystic acne ranging from mild to severe. Subjects discontinued all acne medications and topicals prior to the start of the study. Clinical assessments at baseline, week 4, 8 and 12 included IGA, inflammatory and non-inflammatory lesion counts, clinical grading of PIH/PIE, and texture. Bioinstrumentation included corneometer, tewameter and sebumeter measurements. Questionnaires on perception of efficacy were also completed.&#x0D; RESULTS&#x0D; Fifty-one subjects were recruited with 39 subjects completing the study. The majority were female (67%); racial/ethnic background was comprised of white/caucasian (41%), black (41%) and Asian (13%). Reasons for discontinuation were: lost to follow up/withdrawal (n=7), non-compliance (n=1) and adverse events (n=4). Significant and progressive improvements were seen starting at week 4 in IGA with 85% of subjects showing significant improvements for acne severity at week 12. All lesion counts decreased over the duration of the study with a significant proportion of subjects seeing improvements in inflammatory lesion counts (69%) and non-inflammatory lesion counts (87%). Overall, clinical grading of skin quality parameters progressively improved throughout the duration of the study. Notably PIH/PIE parameters significantly improved in nearly 80% of subjects by week 12. Sebumeter measurements improved significantly with a decrease of 25% as early as week 4 and remained lower than baseline throughout the duration of the study. Skin hydration as measured by the corneometer improved as well. Subjective impressions of improvement as measured by the questionnaire at 12 weeks showed subjects had ‘less breakouts’ (77%), ‘less oily skin’ (74%) and that their ‘acne had improved’ (87%).&#x0D; CONCLUSION&#x0D; The paucity of scientific evidence and lack of clinical data on the efficacy of CAM, including nutraceuticals, have limited their recommendation for use in acne. This proof-of-concept study showed improvements in acne and skin parameters. Although more studies are needed, these results offer insight into the potential benefits of nutraceuticals addressing underlying mechanisms that up to now, have gone largely unexplored. Addressing root causes that contribute to a generalized inflammatory response leading to the development of acne may prove to be an important step in expanding our toolbox in providing more options for patients and improving skin health.

Long-term efficacy and safety of nonablative monopolar radiofrequency in the treatment of moderate to severe acne vulgaris.

Acne vulgaris (AV) is a prevalent skin condition known for its potential to cause scarring and psychological distress, often leading to diminished self-esteem. While topical and oral treatments are commonly prescribed, some patients experience treatment failure, adverse effects, or contraindications to conventional therapies. In response to these challenges, laser and energy-based device therapies have emerged as promising alternatives for individuals who fall into these categories, showing considerable potential in the treatment of AV. This study aimed to evaluate the long-term efficacy and safety of a nonablative monopolar radiofrequency (NMRF) in treatment of moderate to severe AV. Twenty-four patients with moderate to severe AV underwent a series of two NMRF treatment sessions, spaced 4 weeks apart. To evaluate treatment outcomes, live in-person lesion counts and measurements of pore size and volume, and sebum production were quantified using Antera® 3D imaging system, and Sebumeter®, respectively. Patients' self-assessment data regarding degree of improvement and facial oiliness were gathered. Dermatology life quality index (DLQI) questionnaire was utilized to assess the impact of AV on their quality of life. All objective and subjective evaluations were conducted at the baseline, 1 month after the first treatment, and during follow-up visits 1, 3, and 6 months after the last treatment sessions. Adverse effects were also recorded during each visit. Twenty out of the 24 subjects completed the study protocol. The mean inflammatory lesion counts significantly reduced by 42.86% and 45.71% from the baseline at 3 (p = 0.027) and 6 months (p = 0.032) after the second treatment. Sebum excretion likewise significantly decreased from baseline by 11.62% (p = 0.012), 13.37% (p < 0.001), and 21.51% (p = 0.004), 1 month after the first treatment, 1 and 6 months after the second treatment, respectively. The pore volume continued to decrease by 35% (p = 0.003) and 41.5% (p < 0.001) at 1 and 6 months following the final treatment, respectively. The DLQI significantly decreased from 10.00 (interquartile range [IQR]: 6.50-15.00) to 2.00 (IQR: 1.00-4.75), corresponding to 80% improvement of the index, 1 month after the last treatment and was sustained up to the last follow-up visit. Patients' self-assessments on degree of improvement and facial oiliness also significantly improved following NMRF treatments. The treatments were well-tolerated without significant adverse effects. NMRF appears to be an effective and safe treatment for inflammatory AV, with therapeutic outcomes persisting up to 6 months after two treatment sessions.

The efficacy of Topical Clascoterone versus systematic spironolactone for treatment of acne vulgaris: A systematic review and network meta-analysis.

This study aimed to evaluate the effectiveness of topical clascoterone (TC) compared to oral spironolactone for acne vulgaris treatment. A computerized search through PubMed/MEDLINE, SCOPUS, and the Cochrane Library was conducted to find relevant papers. We used the "netmeta" and "meta" packages for network meta-analysis (NMA) in RStudio 1.2.5019 (2009-2019 RStudio, Inc.) to conduct all of our statistical tests. Seven articles (n = 2,006 patients) were included. The fixed-effect size showed that TC 1% bis in die (BID) showed potential effectiveness in reducing the inflammatory and non-inflammatory lesion count compared to placebo (Standardized mean difference, SMD = -0.27, 95% CI: -0.36 to -0.17) and (SMD = -0.31, 95% CI: -0.41 to -0.22), respectively. The random-effect size showed that TC 1% BID was significantly associated with a 12-week treatment success compared to placebo (Odds ratio, OR = 2.44, 95% CI: 1.12 to 5.30). Spironolactone 200 mg was associated with a significant reduction in total lesion count (SMD = -4.46, 95% CI: -5.60 to -3.32). TC appears to reduce both inflammatory and non-inflammatory lesion count and may lead to treatment success. Spironolactone at 200 mg showed potential effectiveness in terms of total lesion count reduction. These results suggest that both TC and Spironolactone could be beneficial in treating patients with acne vulgaris.

A Systematic Literature Review and Network Meta-Analysis of Comparative Efficacy of Topical Fixed-Dose Combination Treatments for Moderate to Severe Acne Vulgaris

INTRODUCTION: Several topical and oral monotherapies/combination treatments are available for treating patients with moderate to severe acne vulgaris and a few are currently under review with the United States (US) Food and Drug Administration (FDA). Among these treatments, topical fixed-dose combinations (FDCs) are widely used in the US. No study has assessed the comparative efficacy of topical FDCs based on the treatment success endpoint of the proportion of patients achieving ≥2 grade reduction AND "Clear" or "Almost clear” status by week 12 on an Investigator's Global Assessment (IGA) or equivalent scales. The objective of this study was to conduct a systematic literature review (SLR) and network meta-analysis (NMA) to compare the efficacy of topical FDCs for the treatment of moderate to severe acne.&#x0D; STUDY DESCRIPTION: An SLR was conducted for identifying randomized controlled trials (RCTs), that included at least one topical FDC (currently approved/under review with FDA) arm, in academic (MEDLINE, Embase, Cochrane CENTRAL, PEDE, and NHS EED) and non-academic databases (HTA databases, conference abstracts databases, and trial registries). The search was conducted in May 2022, based on a pre-specified inclusion/exclusion criterion. RCTs included in the analysis evaluated acne severity using IGA or equivalent (Evaluator's Global Severity Score, Investigator’s Static Global Assessment) scales. A Bayesian network meta-regression was conducted, using the proportion of patients with moderate acne, inflammatory and non-inflammatory lesion counts at baseline as covariates to account for acne severity.&#x0D; RESULTS: Twelve Phase II/III/IV RCTs were identified from 5,159 citations comprising 8,349 patients across 8 treatment groups. The odds ratio for treatment success with topical FDC of clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1% (first triple agent FDC) gel was estimated to be 7.61 (95% Credible Interval: 4.44 –13.20) in comparison to Vehicle gel. Comparative effectiveness ranking demonstrated that the topical triple agent FDC gel was the most effective treatment with surface under cumulative ranking of 100%.&#x0D; CONCLUSION: Based on this SLR/NMA, the topical triple agent FDC of clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1% gel, which is currently under FDA review (PDUFA date 10/20/2023), was clinically superior to all other topical FDC treatments for moderate to severe acne vulgaris.

ANTIHISTAMINE AS AN ADJUNCTIVE TREATMENT IN ACNE VULGARIS: A SYSTEMATIC REVIEW AND META-ANALYSIS

Approximately one-tenth of the global population suffer from acne vulgaris, which is a skin disease with considerable psychological impact. Recently, antihistamines have been used in the treatment of acne. However, their overall treatment effects for this indication remain unclear. This systematic review and meta-analysis aim to evaluate the clinical efficacy and safety of the antihistamines in the treatment of acne vulgaris. The following databases were searched: PubMed, Scopus, Embase, Cochrane Central Register of Controlled Clinical Trials, and Google Scholar. We included the randomized controlled trials on acne vulgaris patients which compared any H1- antihistamine drug in combination with other medications to placebo, no treatment, or other medications, with acne lesion (non-inflammatory and inflammatory) counts, acne severity score, patient satisfaction, acne flare, or adverse events as an outcome of interest. Six studies contributing to 388 patients were included, involving two H1 antihistamines (i.e., levocetrizine and desloratadine), isotretinoin, azithromycin, and topical azelaic acid cream. From the network meta–analysis, levocetirizine+isotretinoin was better than the isotretinoin alone in the inflammatory lesion count, but not in the non-inflammatory lesion count. The desloratadine+isotretinoin retained the best balance in terms of non-inflammatory lesion count, inflammatory lesion count, acne flare, and mucocutaneous adverse events. The desloratadine+isotretinoin and levocetirizine+isotretinoin were considered safe.

Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study.

Atrophic acne scarring often accompanies acne vulgaris. The efficacy of topical retinoids for treatment of acne is well documented; however, evidence for use in atrophic acne scars is limited. In this randomized, split-face, double-blind study, subjects (age: 17-34years, N = 121) with moderate-to-severe facial acne, with acne scars present, were treated with either trifarotene 50μg/g or vehicle once daily for 24weeks. Efficacy was assessed by absolute and percent change from baseline in atrophic acne scar counts, Scar Global assessment (SGA), and IGA success rates as well as acne lesion counts. At week 24, a statistically significantly greater reduction in the mean absolute change from baseline in the total atrophic scar count was noted in the trifarotene- vs vehicle-treated area (- 5.9 vs - 2.7; p < 0.0001) with differences between sides noted as early as week 2 (- 1.5 vs - 0.7; p = 0.0072). The SGA success rate was higher in the trifarotene side at week 12 (14.9% vs 5.0%, P < 0.05) and improved through week 24 (31.3% vs 8.1%, P < 0.001). Similarly, at week 24, the IGA success rate was higher with trifarotene (63.6% vs 31.3%, P < 0.0001) along with reductions in total (70% vs 45%) and inflammatory (76% vs 48%) lesion counts. The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity. Trifarotene was effective and well tolerated in treating moderate-to-severe facial acne and reducing atrophic acne scars, with reduction of total atrophic scar count as early as week 2. Clinicaltrials.gov NCT04856904.

Post-Hoc Exploratory Pooled Analysis of the Impact of IDP-126 Gel on QoL in Moderate-to-Severe Acne.

Acne has psychosocial effects on patient's quality of life (QoL). This post hoc exploratory analysis of pooled phase 3 data assessed the impact of investigational IDP-126 gel (for moderate to severe acne) on the Acne-Specific Quality of Life Questionnaire (Acne-QoL; exploratory endpoint in the trials).&nbsp; Methods: A post hoc exploratory analysis using pooled data (N=309; age &ge;13 years) was conducted to assess if 1) changes from baseline to week 12 in Acne-QoL domain scores significantly differ by treatment; 2) differences were clinically meaningful, and 3) relative importance of acne severity as measured by the Evaluator's Global Severity Score (EGSS) or lesion counts explains the changes in QoL (Acne-QoL).&nbsp; Results: Acne-QoL domain scores significantly (P&lt;0.001, each) improved for patients treated with IDP-126 Gel vs vehicle in all four domains (role-emotional [least squares mean difference {LSMean} 4.1], self-perception [LSMean 3.8], acne symptoms [LSMean 2.6], and role-social [LSMean 2.0]). The proportion of responders was significantly higher (P&lt;0.05, each) in the IDP-126 Gel group vs vehicle across Acne-QoL domains, self-perception (odds ratio [OR]: 4.32), acne symptoms (OR: 3.90), role-social (OR: 3.59), and role-emotional (OR: 2.50). Across all Acne QoL domains, the improvement on the EGSS endpoint (53.8-63.3%) was more likely to influence QoL improvements than the inflammatory (20.1-33.4%) and non-inflammatory lesion (9.5-18.7%) counts.&nbsp; Conclusions:&nbsp;This post hoc exploratory analysis of pooled phase 3 data (moderate to severe acne) suggests that treatment with IDP 126 Gel led to statistically significant and clinically meaningful improvements in QoL and improvement in QoL was primarily influenced by EGSS.J Drugs Dermatol. 2023;22(10):1033-1039&nbsp; &nbsp; &nbsp; doi:10.36849/JDD.7812.

Correlating the Gut Microbiota and Circulating Hormones with Acne Lesion Counts and Skin Biophysical Features.

Acne vulgaris is a common inflammatory condition that is multi-factorial and impacted by both intrinsic and extrinsic features. Several previous studies have assessed for correlations between factors such as circulating hormones, stress, or the microbiome. However, there have not been any correlations specifically against lesion counts or differentiating correlations between inflammatory and non-inflammatory lesion counts. Here, we correlate several factors against acne lesions. Twenty men and women with mild to moderate acne were recruited, and their hormonal levels and their gut microbiome were collected and correlated against their inflammatory and non-inflammatory lesions of acne. Facial non-inflammatory lesions were weakly correlated to sebum excretion rate and weakly inversely correlated to forehead and cheek hydration. We examined stress through the use of a normalized peak-to-trough ratio (higher numbers indicated less stress), which correlated with skin hydration and inversely correlated with sebum excretion rate. Sebum excretion rate was weakly correlated to testosterone levels, and facial hydration correlated with estradiol levels. Correlations with the gut microbiome showed differential correlations with inflammatory and non-inflammatory lesions, with Clostridium sp AF 23-8 correlating to inflammatory lesion counts, while Actinomyces naeslundii str Howell 279 correlated to non-inflammatory lesions. Overall, measures of stress and circulating hormones correlate to skin biophysical properties and acne lesion counts. Also, different gut bacteria correlate with either inflammatory or non-inflammatory lesion counts. We hope that our findings stimulate further work on the gut-mind-stress-skin axis within acne.

A Prospective Randomized Controlled Pilot Study to Assess the Response and Tolerability of Cold Atmospheric Plasma for Rosacea

Introduction: Rosacea is a common, facial, chronic inflammatory skin disease. Due to its complex pathogenesis, adequate therapy of rosacea can be challenging. An innovative recent therapeutic tool is cold atmospheric plasma (CAP), which is already established in the treatment of chronic wounds and promising in different other skin diseases. Methods: In a split-face pilot study we investigated dielectric-barrier-discharged CAP in erythemato-telangiectatic (ETR) and/or papulopustular rosacea (PPR). CAP treatment was applied on lesional skin of a randomized side once daily (90 s/area) for 6 weeks. The other untreated side served as control. Co-primary endpoints were ≥1 improvement of the Investigator Global Assessment (IGA) score on the treated side compared to control and a decline of the Dermatology Life Quality Index (DLQI) after 6 weeks. Secondary endpoints included inflammatory lesion count (papules and pustules), skin redness intensity and erythema size. Adverse events (AEs) were recorded constantly. Additionally, participants were weekly assessed for symptoms, skin condition, trigger factors, skin care, treatment success, and local tolerance parameters. All p values were calculated using the Wilcoxon signed-rank test. Results: Twelve subjects (ETR, n = 3; ETR and PPR, n = 9) completed the study. DLQI was significantly improved after 6 weeks (p = 0.007). On the CAP-treated side, lesions (p = 0.007) and erythema size (p = 0.041) were significantly reduced compared to the control. IGA (p = 0.2) and skin redness intensity (p = 0.5) did not differ significantly between control and CAP-treated side. No serious AEs occurred and treatment was well tolerated. Conclusion: CAP is a promising new treatment of rosacea, especially for PPR.

Efficacy and safety of microencapsulated benzoyl peroxide and microencapsulated tretinoin for the treatment of acne vulgaris: Results from two phase 3 double-blind, randomized, vehicle-controlled studies

Benzoyl peroxide and tretinoin are commonly prescribed acne treatments. Historically, they have been difficult to combine in a single formulation due to chemical instability, and both medications are potentially irritating. Microencapsulation helps overcome these challenges. Examine efficacy, safety, and tolerability of encapsulated BPO/encapsulated tretinoin (E-BPO/T) cream, 3%/0.1%. Subjects ≥9 years old with moderate to severe acne were enrolled in 2 multicenter, double-blind, vehicle-controlled, parallel trials and randomized (2:1) to 12weeks of once-daily E-BPO/T (n=571) or vehicle cream (n=287). E-BPO/T was significantly superior to vehicle in both studies, with more subjects achieving IGA success with E-BPO/T (38.5%/25.4%) versus vehicle (11.5%/14.7%; P<.001/P=.017). The change from baseline in inflammatory lesion count for E-BPO/T was -21.6 versus -14.8 for vehicle (P<.001) in study 1 and -16.2 versus -14.1 (P=.018) in study 2. The changes from baseline in noninflammatory lesions for E-BPO/T were -29.7 versus -19.8 for vehicle (P<.001) and -24.2 and -17.4 (P<.001) in studies 1 and 2, respectively. E-BPO/T was well tolerated in both studies. Long-term data are not available. E-BPO/T provided statistically significant and clinically relevant improvements in IGA and inflammatory and noninflammatory lesion counts and was well tolerated in subjects with moderate to severe acne.