Noninflammatory Lesion Counts Research Articles

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 < 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.

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.

Treatments for Moderate-to-Severe Acne Vulgaris: A Systematic Review and Network Meta-analysis.

Multiple treatment options exist for the management of moderate-to-severe acne. However, the comparative effectiveness (efficacy/safety) of moderate-to-severe acne treatments has not been systematically examined. A systematic literature review (SLR) was conducted to identify randomized controlled trials of ≥4 weeks of treatment (topical, oral, physical, or combinations) for moderate-to-severe facial acne in patients aged ≥9 years. Efficacy outcomes included: percentage of patients achieving ≥2-grade reduction from baseline and “clear” or “almost clear” for global severity score (treatment success); absolute change in inflammatory (ILs reduction); and noninflammatory lesion counts (NILs reduction). A random-effects network meta-analysis (NMA) was conducted for the efficacy outcomes. Treatments were ranked with posterior rank plots and surface under cumulative ranking values.  Results: Eighty-five studies were included in the SLR/NMA. Topical triple-agent fixed-dose combination (FDC) gel (clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) and combinations of double-agent fixed-dose topical treatments with oral antibiotics (TOA3) consistently ranked in the top 3 treatments. Topical triple-agent FDC gel was numerically superior to TOA3 for treatment success (log-odds ratios: 1.84 [95% credible interval (CrI) 1.36 to 2.29]) and 1.69 (95% CrI: 1.01 to 2.32) vs placebo/vehicle). TOA3 was numerically superior to topical triple-agent FDC gel for reduction of ILs (mean difference: -8.21 [-10.33 to -6.13]) and -10.40 [-13.44 to -7.14] vs placebo/vehicle) and NILs (mean difference: -13.41 [-16.69 to -10.32] and -17.74 [-22.56 to -12.85] vs placebo/vehicle). Based on this SLR/NMA, topical triple-agent FDC gel was the most efficacious and safe treatment for moderate-to-severe acne. J Drugs Dermatol. 2024;23(4):     doi:10.36849/JDD.8148.

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.
 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).
 Results: At week 12, 51.5% of CAB–treated participants aged ≥12 years achieved treatment success vs 24.9% with vehicle gel (P<0.01). CAB treatment resulted in significant reductions of >70% in inflammatory and noninflammatory lesion counts in adolescents (78.3% and 73.7%, respectively) vs vehicle (50.5% and 42.9%; P<0.001, both). Most TEAEs were of mild-to-moderate severity, and the most common (>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 <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.
 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.
 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.
 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).
 Results: At week 12 in both age groups, least-squares mean percent reductions from baseline were >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<0.01, both) and noninflammatory lesions (9-24 y: 72.8% vs 44.5%; ≥25 y: 73.7% vs 55.2%; P<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<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.
 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.
 Funding: Ortho Dermatologics

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

INTRODUCTION
 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. 
 DESIGN
 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.
 RESULTS
 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%).
 CONCLUSION
 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.

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.
 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.
 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%.
 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.

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).  Methods: A post hoc exploratory analysis using pooled data (N=309; age ≥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).  Results: Acne-QoL domain scores significantly (P<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<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.  Conclusions: 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      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.

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.

DMT310, a novel once-weekly topical treatment for patients with moderate-to-severe acne vulgaris: Results of a phase 2b randomized, double-blind, placebo-controlled trial

Poor patient adherence with antiacne medications is a common clinical challenge. DMT310, a natural, topical product with a once-weekly application schedule, may alleviate this obstacle. Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne. This 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled participants 12years and older with moderate-to-severe acne. The intent-to-treat population included a total of 181 participants (DMT310, N=91; placebo, N=90). Participants who received DMT310 vs participants treated with placebo demonstrated a statistically significant greater reduction in the number of inflammatory and noninflammatory lesions at all time points: inflammatory lesion counts at week 12 (-15.64 vs -10.84, P<.001); noninflammatory lesion counts at week 12 (-18.26 vs -12.41, P<.001). DMT310-treated participants also had higher rates of Investigator's Global Assessment treatment success than participants in the placebo group at all time points: Investigator's Global Assessment at week 12 (44.40% vs 17.78%; P<.001). No serious treatment related adverse events occurred. DMT310 once-weekly topical treatment significantly reduced both inflammatory and noninflammatory lesions and yielded a greater proportion of Investigator's Global Assessment treatment success at all time points in participants with moderate-to-severe acne.

A Novel, Hand-Held, and Low-Level Light Therapy Device for the Treatment of Acne Vulgaris: A Single-Arm, Prospective Clinical Study

There is an increasing demand for low-level light therapy devices for the treatment of dermatologic conditions, such as acne, hair loss, undesirable body hair, and skin aging. This study evaluated the safety and effectiveness of a novel hand-held low-level light therapy device with a 680 nm red laser diode and a 450 nm blue light-emitting diode for the treatment of mild-to-moderate acne. A prospective clinical study was conducted on 57 patients with mild-to-moderate acne and Fitzpatrick skin types II–IV. Treatments were self-administered by the patients at home daily for 4 weeks. Conventional treatment was restricted during the study period. The number of inflammatory and noninflammatory lesion counts, Investigator’s Global Assessment grade, patients’ self-assessment, and adverse events were measured every two weeks, and follow-ups were performed until four weeks after the final treatment. Moreover, we evaluated the bactericidal effect of low-level light therapy on Cutibacterium acnes, a causative agent of acne vulgaris, in vitro. The mean number of inflammatory acne lesions decreased statistically at weeks 4 ( ∗ ∗ ∗ p &lt; 0.001 ) and 8 ( ∗ ∗ ∗ p &lt; 0.001 ). The proportion of Investigator’s Global Assessment grade 3, indicating moderate acne severity, decreased significantly at the final visit. No severe adverse reactions were reported. Furthermore, there was a significant reduction in the viability of Cutibacterium acnes following low-level light therapy exposure in vitro. The results of this study demonstrate that this novel, hand-held, and low-level light therapy device are safe and effective for the treatment of inflammatory acne, with good adherence.

Safety and efficacy of nadifloxacin versus clindamycin observed in a tertiary care teaching hospital of Deccan Plateau

Acne vulgaris is characterised by excess sebum production and inflammatory reaction in sebaceous glands. As propionibacterium is involved in aggravation of acne, antimicrobials like nadifloxacin and clindamycin were found to be effective in treatment.Comparison of nadifloxacin with clindamycin in terms of inflammatory and non-inflammatory lesion count and global improvement rating, when given in combination with benzoyl peroxide in patients in acne vulgarisNadifloxacin 1%, benzoyl peroxide 2.5% and clindamycin 1% were used as topical treatment option. Study cohort was randomly divided into two groups: Nadifloxacin group and Clindamycin group. All subjects who were included in the study were instructed to apply a thin layer of medication over acne lesions; benzoyl peroxide 2.5% gel once daily at bedtime and clindamycin 1% gel or Nadifloxacin 1% gel twice daily. Efficacy is analysed by comparing changes in total, inflammatory and non-inflammatory lesion counts, In addition, global improvement was rated by patients using a six-point scale (worsening, no improvement, slight improvement, moderate improvement, good improvement, clearance) at end of treatment.There is progressive decline in number of inflammatory and non-inflammatory lesions in both groups. Analysis of lesion counts not showed any significant difference in between two groups. In global improvement rating scale, more number of patients using nadifloxacin with benzoyl peroxide reported good improvement compared to patients using Clindamycin with benzoyl peroxide. No patient in any group reported worsening of lesions. None of patients in study groups reported clearance. Two adverse events were reported during study, they were, burning sensation and dryness. There was no significant difference in incidence of adverse events in both treatment groups.Topical Nadifloxacin, a new fluoroquinolone is effective, tolerable and safe for mild or moderate facial acne. Its clinical effectiveness is equivalent to clindamycin when used as add-on therapy to benzoyl peroxide.

Prospective Placebo-Controlled Assessment of Spore-Based Probiotic Supplementation on Sebum Production, Skin Barrier Function, and Acne.

Probiotic supplementation has been shown to modulate the gut-skin axis. The goal of this study was to investigate whether oral spore-based probiotic ingestion modulates the gut microbiome, plasma short-chain fatty acids (SCFAs), and skin biophysical properties. This was a single-blinded, 8-week study (NCT03605108) in which 25 participants, 7 with noncystic acne, were assigned to take placebo capsules for the first 4 weeks, followed by 4 weeks of probiotic supplementation. Blood and stool collection, facial photography, sebum production, transepidermal water loss (TEWL), skin hydration measurements, and acne assessments were performed at baseline, 4, and 8 weeks. Probiotic supplementation resulted in a decreasing trend for the facial sebum excretion rate and increased TEWL overall. Subanalysis of the participants with acne showed improvement in total, noninflammatory, and inflammatory lesion counts, along with improvements in markers of gut permeability. The gut microbiome of the nonacne population had an increase in the relative abundance of Akkermansia, while the subpopulation of those with acne had an increase in the relative abundance of Lachnospiraceae and Ruminococcus gnavus. Probiotic supplementation augmented the circulating acetate/propionate ratio. There is preliminary evidence for the use of spore-based probiotic supplementation to shift the gut microbiome and augment short-chain fatty acids in those with and without acne. Further spore-based supplementation studies in those with noncystic acne are warranted.

Montelukast as an effective adjuvant in the treatment of moderate acne vulgaris.

Although antibiotics are among the most commonly used treatments of acne, there are refractory cases, or they can cause some complications. Recently, leukotriene B4 has been found to play a major role in inflammatory acne lesions. This double blind, randomized clinical trial was conducted on 108 patients with acne who needed systemic therapy and referred to dermatology clinics affiliated to Shiraz University of Medical Sciences. One group (53 patients) received 100 mg doxycycline daily plus placebo and the other group (55 patients) received 100 mg daily doxycycline plus 10mg daily montelukast. Both groups also received topical benzoyl peroxide 5% every other night. The study period was 3 months and the patients were investigated by lesion count, investigator global assessment (IGA), global acne grading system (GAGS), and Cardiff acne disability index (CADI) scoring systems. Total lesion count, inflammatory lesion count, and non-inflammatory lesion count as well as IGA and GAGS decreased in both treatment groups. At the end of the study, however, the inflammatory lesion count and IGA score reduced more significantly in the montelukast group (p=0.018 and 0.045, respectively). In addition, the two groups were significantly different with regard to the percentage of decrease in the total lesion count, inflammatory lesions, and IGA (p=0.033, 0.003, and 0.044, respectively). Thus, montelukast can be used as an adjuvant therapy besides other treatments of acne, especially for inflammatory lesions.

Efficacy and Safety of Tazarotene Lotion, 0.045% in the Treatment of Truncal Acne Vulgaris.

Although truncal acne is thought to have the same pathophysiology as facial acne, treatment response may differ based on body area involvement. Traditionally, prescribers have relied on oral therapies for the management of truncal acne, possibly because oral therapy has been considered more convenient than topical application of medication to the chest and back. A lotion formulation may be particularly well-suited for the treatment of truncal acne. Tazarotene lotion, 0.045% is FDA approved for treatment of acne vulgaris in individuals 9 years of age or older. This pilot study was designed to investigate the efficacy and safety of Arazlo lotion for the treatment of truncal acne. A total of 19 subjects ranging in age from 12 to 58 years completed the 12-week study. There were significant reductions in truncal IGA (the primary endpoint) at each of the study follow-up visits. At week 12, 89% of subjects were clear or almost clear, as assessed by truncal IGA score. There were statistically significant reductions in inflammatory, non-inflammatory, and total lesion counts from baseline to week 12. Treatment with tazarotene lotion 0.045% was well-tolerated, with erythema, dryness, peeling, oiliness, pruritis, and burning generally rated as trace or mild. Most subjects (64% or more) rated the lotion as &ldquo;Good&rdquo; or &ldquo;Excellent&rdquo; in general and in comparison to their prior medications. Tazarotene lotion, 0.045% is shown to be effective and well-tolerated for the management of truncal acne in this pilot study. Further studies with placebo control and larger populations are warranted. J Drugs Dermatol. 2022;21(7):713-716. doi:10.36849/JDD.6967.

Clindamycin phosphate, tretinoin with benzoyl peroxide versus clindamycin phosphate and tretinoin combination without benzoyl peroxide for the treatment of acne vulgaris

Introduction: Acne vulgaris (AV) is a prevalent skin disorder among adolescents. Affects around 80–90% of adolescents in the Western population. The present study aimed to compare the therapeutic efficacy of Clindamycin phosphate (CLM), Tretinoin (TN) with Benzoyl peroxide (BP) versus clindamycin phosphate and tretinoin combination without Benzoyl peroxide for treatment of AV. Methodology: 250 patients with mild to moderate acne on the face were enrolled in the study and were divided into two groups; group I (n=125); apply CLM 1.2%, TN 0.025%gel with BP 3.75% gel and group II (n=125) apply only CLM 1.2% and TN 0.025% gel without BP 3.75% gel; once daily at night for 4 weeks. The change in acne lesions was recorded every 2 weekly follow-ups using the global acne grading system and non-inflammatory (NI-L), Inflammatory (I-L) lesions count and Investigator's Static Global Assessment grading. Results: The research involved 250 patients split into two groups: 125 patients in group I and 125 patients in group II. After 4 weeks, the group I had a higher mean percent decrease in non-inflammatory, inflammatory, and total lesion count than group II.

A Pharmacovigilance Study of Topical Acne Monotherapy with 0.1% Adapalene, and A Molecular Analytical Review of Adapalene in Evidence-Based Dermatopharmacological Treatment

Acne vulgaris causes cosmetic impairment. User-friendly anti-acne monotherapy with adapalene has activity against the acne pathophysiology, with very minimal adverse effects. Retinoids, like adapalene, are comedolytic and anti-inflammatory. This study was conducted as a pharmacovigilance study of topical acne monotherapy with 0.1% adapalene, and a molecular analytical review of adapalene in evidence-based dermatopharmacological treatment. A prospective, open- labelled study was done, on 75 patients, with mild to moderate acne. Patients applied 0.1% adapalene topical monotherapy, once daily in the evening, over affected areas on the face, and left overnight. Efficacy was measured by percentage reduction in non-inflammatory, inflammatory and total lesion counts on 0, 15, 30, 60 and 90 days; and severity of lesions was assessed by Investigator’s Global Evaluation Scale and the occurrence of adverse effects like erythyma, dryness, scaling, burning and pruritus, were assessed by the Local Irritation Scale, among the patients receiving the monotherapy. An analytical review of the molecular pharmacology of adapalene in evidence-based dermatopharmacological treatment was thoroughly performed. The patients showed highly significant reduction in total lesion counts from baseline. No serious adverse effects were observed; and the observations were statistically non-significant. The molecular analytical review described significantly effective evidence-based dermatopharmacological response mechanisms of adapalene therapeutics. Topical 0.1% adapalene monotherapy was effective and safe, with significant evidence-based molecular dermatopharmacological efficacy.

The Anti-Acne Effect of Near-Infrared Low-Level Laser Therapy.

BackgroundAcne vulgaris is a skin problem affecting many people of different ages. Phototherapy is one of the acne treatment options. The aim of the study was to assess the effect of near-infrared low-level laser therapy on acne lesions.Materials and MethodsThe prospective study involved a total number of 27 women, aged 18 to 45 years, with mild to severe acne. All the participants underwent a series of six treatments with the use of a 785 nm low-level laser with the power density 80mW/cm2, performed every two weeks. The analysis of the effectiveness of the performed procedures was based on sebumetric examination, photographic documentation and assessment of the change in the number of acne lesions.ResultsSignificant improvements in acne lesions (assessed as non-inflammatory and inflammatory lesion counts) and a significant decrease in skin sebum excretion were observed after the treatment. No adverse effects were reported.ConclusionA series of six treatments using a near-infrared low-level laser represents a safe and effective non-invasive therapy option for acne vulgaris.