Non-inflammatory Lesions Research Articles

Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Black Participants with Moderate-to-Severe Acne

Introduction: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose, triple-combination formulation approved for the treatment of acne, and is indicated in patients 12 years of age and older. In 3 clinical studies of participants with moderate-to-severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. To better understand the efficacy and safety of CAB gel in patients with darker skin phototypes, this post hoc analysis included participants who self-identified as ‘Black or African American’ (hereafter referred to as Black). Methods: Data were pooled from a phase 2 (N=741) and two phase 3 (N=183; N=180), 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. Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in inflammatory/ noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were also assessed. Results: Of 657 participants randomized to CAB or vehicle gel, 104 (15.8%) self-identified as Black (n=64 CAB, n=40 vehicle). At week 12, 31.5% of Black participants treated with CAB achieved treatment success, compared to 17.3% with vehicle. Inflammatory lesion reductions with CAB were significantly greater than with vehicle (69.0% vs 53.6%, P<0.01), and noninflammatory lesion reductions were numerically greater with CAB than with vehicle (58.3% vs 51.9%). The rate of TEAEs with CAB treatment in Black participants was generally lower than in the overall study population (23.4% vs 24.6-36.2%), and most TEAEs were of mild-to-moderate severity. Conclusions: Fixed-dose, triple-combination CAB gel was efficacious and well tolerated in Black participants with moderate-to-severe acne. Despite the limited number of self-identified Black participants across the clinical studies of CAB gel, these post hoc analyses add valuable information to the limited literature describing treatment effects of fixed-dose combination acne treatments in Black individuals. Funding: Ortho Dermatologics

Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants with Moderate-to-Severe Acne: The Patient Journey

Introduction: The main goal of acne treatment is to clear lesions quickly to manage and/or mitigate sequelae. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination approved for acne. In three published clinical studies of participants with moderate to severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. Herein are presented detailed efficacy and safety data from 5 clinical study patients to document their CAB treatment journey. Methods: In two phase 3 (NCT04214652, NCT04214639), double-blind, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and percent change from baseline in inflammatory/ noninflammatory lesion counts. Dosing compliance, treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. Descriptive data from 5 selected cases who completed 12 weeks of CAB treatment are summarized. Results: Participants (n=5) ranged from 13-32 years. At week 12, 3 achieved treatment success, 1 achieved a 2-grade reduction from severe to mild, and 1 achieved a 1-grade reduction from moderate to mild. Reductions from baseline to week 12 in inflammatory/ noninflammatory lesion counts ranged from 74.7-100%. No participants reported TEAEs/serious AEs. Some cutaneous safety/tolerability scores increased at weeks 2, 4, or 8, but generally decreased back to/below baselines levels by week 12, similar to the overall study populations. Most scores at week 12 were 0 (none) or 1 (mild), with only one participant reporting scores of 2 (moderate) for itching, burning, and stinging. Conclusions: In the overall phase 3 clinical trials, fixed-dose, triple-combination CAB gel has demonstrated good efficacy, safety, and tolerability. All 5 cases presented here achieved substantial (>70%) acne lesion reductions, with 4/5 cases achieving treatment success or a 2-grade EGSS reduction by week 12. While patterns in cutaneous safety/tolerability were variable across cases, transient increases with CAB generally resolved to baseline values within two months of treatment. These clinical study cases reinforce the importance of patient education regarding efficacy and safety of acne treatment, including the importance of treatment adherence, managing patient expectations, and the potential for cutaneous effects, which are often transient. Support: Ortho Dermatologics

Sarecycline for moderate to severe acne: a promising narrow-spectrum antibacterial drug.

Sarecycline, a narrow-spectrum antibacterial drug approved by the FDA in 2018, targets Cutibacterium acnes while potentially minimizing disruption to the gut microbiota. The aim of this study is to assess the efficacy and safety of sarecycline compared to placebo in treating moderate to severe facial acne. A comprehensive search of PubMed, MEDLINE, and Cochrane databases was performed, with data extraction and screening conducted independently by two authors. Statistical analysis used RevMan, and the risk of bias was evaluated using RoB 2. Three RCTs (n = 2287 patients, mean age 19.6-20.8years) met the inclusion criteria. Sarecycline (1.5mg/kg) administered daily for 12weeks significantly reduced inflammatory and non-inflammatory lesion counts compared to placebo (p < 0.00001). Other outcomes were not statistically significant. Sarecycline 1.5mg/kg daily is an effective and well-tolerated treatment for moderate to severe acne with minimal side effects.

Histopathological Profile of Cholecystectomy Specimens at a Tertiary Care Center: A Retrospective Study

Abstract Introduction: Gallbladder is one of the most frequently received specimens in any histopathology laboratory. Its diseases may present with a varied spectrum ranging from congenital anomalies, cholelithiasis, and inflammatory or noninflammatory lesions to noninvasive and invasive neoplasms. Cholelithiasis (gallstones) is the most common lesion and accounts for more than 95% of gallbladder diseases and affects 10%–20% of the adult population. The incidence is 2–4 times higher in females than in males. Aims and Objectives: This study was designed to study the histopathological spectrum of gall bladder diseases in the population, study the most common gall bladder diseases in cholecystectomy specimens, and study the frequency of gall bladder carcinoma. Methodology: This retrospective observational study was done in the Pathology department at a tertiary care hospital and research center, from September 2016 to September 2023. Tissue was fixed in 10% buffered formalin and then processed by the routine paraffin embedding techniques. Sections were cut at 4–5 μ thickness and stained with hematoxylin and eosin stains. Special stains were done if required for confirmation. All the slides were analyzed and reported by a trained histopathologist. Results: Females were affected more as compared to males. The commonest age group affected was 41-50 years. Gallstones were observed in 33.58% of patients. Gallbladder neoplasm was rare and incidental findings. Conclusion: Gallbladder disease demonstrated a diverse spectrum of histopathological changes in the cholecystectomy specimens and showed female preponderance. Gallbladder carcinoma was observed as a rare occurrence and was an incidental finding mainly. Hence, a microscopic (histopathological) examination is required for every cholecystectomy specimen.

Acne-related UVA-induced facial fluorescence: An exploratory study from physiological properties to tissue structure information

UVA-induced facial fluorescence (UVAF) is recognized as an objective measurement technique to quantify the severity of acne. However, notable inconsistencies in quantitative outcomes have been observed in various studies, possibly due to the fact that different colors of fluorescence represent different pathophysiological implications. This study investigated the pathophysiological importance of UVAF color differences and improved its reliability in assessing acne severity. MIDOO Smart Skin Imager was used to capture UVAF and analyze the correlation between fluorescence colors and acne lesions. Techniques such as two-photon excited fluorescence microscopy, scanning electron microscopy, western blot, and high performance liquid chromatography-mass spectrometry (HPLC-MS/MS) were used to examine the biochemical composition and structure of comedonal plugs and follicular casts associated with different fluorescence colors. We found that green fluorescence correlates with non-inflammatory acne lesions (comedones), while orange-red fluorescence shows no correlation with either type of lesion. Green fluorescence is associated with higher levels of keratin, indicating keratinization, while orange-red fluorescence is associated with porphyrin from S. epidermidis. UVAF color differences - orange-red are from porphyrins and green from keratin. This distinction helps to understand the structural and physiological bases of facial fluorescence, with potential implications for clinical evaluations of acne.

Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis.

Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the only fixed-dose triple-combination treatment approved for acne. This post hoc analysis assessed the impact of sex on efficacy and safety/tolerability of CAB. In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants aged &ge;9 years with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed by sex. Assessments included treatment success (&ge;2-grade reduction from baseline in Evaluator&rsquo;s Global Severity Score and a score of 0 [clear] or 1 [almost clear]), inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability. At week 12, treatment success rates were significantly greater with CAB versus vehicle irrespective of sex (females: 53.7% vs 23.0%; males: 43.1% vs 24.6%; P&lt;0.05, both). CAB-treated female and male participants both experienced greater reductions from baseline versus vehicle in inflammatory (females: 77.7% vs 57.9%; males: 77.5% vs 57.1%; P&lt;0.001, both) and noninflammatory lesions (females: 72.5% vs 45.6%; males: 72.3% vs 49.6%; P&lt;0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than vehicle. No significant differences in any efficacy measures between CAB-treated males and females were observed. Most TEAEs were of mild-to-moderate severity; no sex-based trends for safety/tolerability were observed. CAB demonstrated comparable efficacy, quality-of-life improvements, and safety in female and male participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment for acne. J Drugs Dermatol. 2024;23(10):873-881. doi:10.36849/JDD.8484.

Anti-acne and Tolerance Assessment of a Cleanser Containing Salicylic acid, Gluconolactone and Niacinamide

Purpose: Acne has potential to cause psychological distress and significantly diminish one's quality of life. Although washing and over-the-counter cleansers are commonly used in the treatment of acne vulgaris, clinical evidence supporting their effectiveness is still limited. The main focus of this research is to explore anti-acne effectiveness and mildness of a cleanser containing salicylic acid, gluconolactone, and niacinamide.Methods: We recruited two groups of participants. One group consisted of 43 individuals with oily acne-prone skin, and we measured their inflammatory lesions, non-inflammatory lesions, and sebum content after 4 weeks of product usage. The other group included 39 individuals with sensitive skin, and we assessed objective irritation parameters and subjective irritation parameters after 2 weeks’ product usage.Results: After 4 weeks of using cleanser containing retinol, niacinamide and ceramides on oily acne-prone skin, significant reductions were observed in both inflammatory acne lesions count and non-inflammatory acne lesions count, while there was also a significant decrease in skin sebum content. After two weeks of use on sensitive skin, significant improvements were observed in both subjective and objective irritation parameters.Conclusion: In summary, a cleanser containing salicylic acid, gluconolactone and niacinamide can effectively improve acne symptoms while being gentle enough for use on sensitive skin.

Clinical Evaluation of the Efficacy, Safety, and In-Use Tolerability of a Diacnemide™-Containing Acne Kit (Facial Serum and Cleanser) Regimen for the Synergistic Management of Facial Acne in Adults.

Introduction Acne is a common inflammatory condition characterized by comedones, papules, and pustules, often resulting from increased sebum production influenced by hormones such as insulin-like growth factor-1 and androgens. Factors like Cutibacterium acnes, medications, sun exposure, cosmetics, and genetics exacerbate acne. This study aims to assess the safety and effectiveness of a novel acne treatment regimen, including a cleanser and serum containing Diacnemide™ (manufactured by Beaucience India Private Limited, Faridabad, India), in improving acne symptoms in adults. Methods This prospective, interventional, open-label, single-center, single-arm clinical study was designed to evaluate the safety, efficacy, and in-use tolerability of the test treatment regimen (serum + cleanser) for facial acne. Ethical approval was obtained from the Independent Ethics Committee, and all participants provided written consent. The study assessed changes in the severity of acne by dermatological assessment using the Investigator's Global Assessment (IGA) scale, changes in inflammatory and non-inflammatory lesions, skin hydration, sebum levels, and facial blemishes using various bioinstrumentations from Courage+Khazaka Electronic GmbH, Germany - Visiopor® PP34N, Corneometer® CM 825, Sebumeter® SM 815, and Mexameter® MX 18, respectively. Evaluations were conducted at baseline, T15 minutes, day 8, and day 15 post-usage. Statistical analyses were performed using SPSS (version 29.0.1.0) and Microsoft® Excel 2019 software, with results reported using p-values and confidence intervals at a 5% significance level. Results Porphyrin measurements showed significant reductions over time, with a 27.18% decrease in quantity and a 39.86% reduction by day 15 (p < 0.0001). Porphyrin values dropped by 2.61% after 15 minutes and 7.82% by day 15 (p < 0.05). Skin hydration increased significantly, with a 97.54% increment after 15 minutes and a 102.74% increment by day 15 (p < 0.0001). Sebum levels were restored to normal levels with the dry skin observed at baseline, showing a 34.45% improvement on day 8 and 75.75% by day 15 (p < 0.0001). Facial dark spots were reduced by 10.66% by day 8 and 14.64% by day 15 (p < 0.0001), and erythema levels decreased significantly. Acne severity showed notable improvement, with 50% of the subjects having moderate acne at baseline, reduced to 20.69% with mild acne, and 79.31% with almost clear skin by day 15. Subject responses indicated high satisfaction, with 100% agreeing on the test treatment's effectiveness in reducing acne, oiliness, and inflammation and improving hydration and skin texture. Conclusion The ThriveCo acne regimen (serum + cleanser)manufactured by Anveya Living Private Limited, India, is both effective and safe for treating facial acne in healthy adults with acne. It significantly reduces porphyrin size and quantity, indicating a strong inhibition of P. acnes, and visibly improves dark spots and skin hydration. The components - Diacnemide™ and zinc pyrrolidone carboxylic acid - in the cleanser regulate sebum production and provide anti-inflammatory benefits, while the serum, containing Diacnemide™ and niacinamide, enhances skin barrier function and balances lipids. The synergistic effects of the ThriveCo Goodbye Acne Cleanser and Serum in this regimen effectively target surface bacteria like C. acnes and deeper follicular issues, promoting healthier skin and reducing acne-related symptoms.

Comparison of blue laser and red light-emitting diode-mediated aminolevulinic acid-based photodynamic therapy for moderate and severe acne vulgaris: A prospective, split-face, nonrandomized controlled study

BackgroundAcne is a chronic inflammatory skin disease. Photodynamic therapy (PDT) is a highly effective and safe drug-device combination treatment, typically using red and blue light. However, direct comparisons of aminolevulinic acid (ALA)-based PDT using these two light sources are lacking. Therefore, we compared the efficacy and adverse effects of ALA-based 450 nm blue laser-mediated PDT (BL-PDT) and 630 ± 10 nm red light-emitting diode-mediated PDT (RL-PDT) in the treatment of moderate-to-severe acne vulgaris, including analyses of different lesion types. MethodsSixteen patients with moderate-to-severe acne vulgaris were recruited. All patients underwent BL-PDT on the left side of the face and RL-PDT on the right side. Treatments were administered thrice at 2-week intervals, and follow-up continued for 2 weeks after the final treatment. The average rates of improvement in inflammatory and non-inflammatory acne lesions, IGA (Investigator's Global Assessment) scales, and IGA success rates were calculated. In addition, adverse effects during and after each treatment were recorded. ResultsAt the 2-week follow-up after the final treatment, the average rates of improvement in total acne, inflammatory, and non-inflammatory lesions were 48.0 %, 63.0 %, and 30.0 % in the BL-PDT group and 42.2 %, 58.1 %, and 27.5 % in the RL-PDT group, respectively. The IGA scores for the two groups decreased by 1.8 and 1.7 points, respectively, and the IGA success rate was 53.3 % in both groups. There were no significant differences between the BL-PDT and RL-PDT groups in any measure of effectiveness. However, the BL-PDT group exhibited more severe adverse effects, especially pain and hyperpigmentation. ConclusionsBL-PDT and RL-PDT have similar efficacies in moderate-to-severe acne vulgaris and are particularly effective for inflammatory acne lesions. RL-PDT benefits from milder adverse effects than those of BL-PDT.

Efficacy, Tolerability, and Face Lipidomic Modification of New Regimen with Cleanser and Corrective Serum in Women with Acne-Prone Skin

Acne-prone skin is a common condition in adult women, and skin imperfections could affect quality of life and self-esteem. This study aimed to investigate the efficacy of a cosmetic combination regimen for face care (a cleanser gel and a serum containing niacinamide, retinol, and alpha hydroxy acids). A total of 20 women with acne-prone mixed or oily skin were enrolled in a prospective 42-day trial. Sebum content, skin radiance, skin profilometry, and evaluation of face area occupied by pores were evaluated at baseline and after 14, 28, and 42 days. In addition, a face lipidomic evaluation was performed at baseline and after 42 days. Finally, self-assessment questionnaires at each visit checkpoint were performed to evaluate efficacy and tolerability of the tested products. All the subjects but one concluded the study. Both products were very well tolerated and 84% of the subjects reported a global clinical improvement. Skin sebum content was significantly (p &lt; 0.05) reduced at each of the evaluation time points (−9.9% at day 14, −19.4% at day 28, and −23.7% at day 42). The tested regimen significantly decreased the gloss parameter (mattifying effect) at day 14, 28, and 42, with a maximum reduction of 7.2% at the end of the study period. The pores area demonstrated a significant reduction at each of the checkpoint evaluations in comparison with baseline. Inflammatory and non-inflammatory lesions were significantly reduced by 16% at day 28 and day 42 (p &lt; 0.01). Lipidomic analysis demonstrated that this cosmetic face care regimen induced significant and positive effects in face sebum lipids composition, characterized by a significant increase in ceramides and triacylglycerols and a decrease in fatty acids and oxidized fatty acids.

52843 A dermocosmetic reduces the peak number of non-inflammatory lesions and the peak sebum level during the menstrual cycle

52843 A dermocosmetic reduces the peak number of non-inflammatory lesions and the peak sebum level during the menstrual cycle

Systematic literature review of acne vulgaris, its sophisticated treatment approaches, types, treatment and their side effects.

Background: Acne formation can be controlled effectively but it heals slowly and has numerous interactions with neuropeptides. Once gone another one pops up. Sometimes it can be filled with pus. Its size varies and can cause anxiety, depression, stress and social withdrawal. The mechanism is hyper secretion of sebaceous glands. Introduction: Acne vulgaris is a condition when hair follicles are accumulated with oil, dead cells and bacteria from skin. It can lead to formation of blackhead, whitehead, oily skin, pimples and scarring eventually. Patients have raised sebum level and thus skin is more prone to acne formation; triggered by propionibacterium, genetics, environment and food. Most commonly occurring on the face, upper limb and trunk between teen to middle age. Sebum contains wax esters, cholesterol, and triglyceride. Objectives: · To extensively explain the etiology of acne vulgaris, hormonal, bacterial causes and UV light. · To write comprehensive review on treatment of AV conventional, topical, retinoid and antibiotics based treatment. · Write a comprehensive review on its complications and its management. Methodology: In this research article we have explained systematic review, as well as we have described the systematic literature review of Acne Vulgaris, We did a literature search using electronic bibliographic databases and Journals : such as ELSEVIER ,British Medical Journals ,MEDLINE (Ovid SP and PubMed), EMBASE, The Cochrane Library (Cochrane Database of Systematic Reviews (CDSR), and Cochrane Central Register of Controlled Trials (CENTRAL), as well as annual meetings abstracts from inception till Oct 2024. The literature search has focused mainly on randomized clinical trials, Meta-analysis, phase II/III, and retrospective studies. Results and Conclusion: The review included 45 studies with a total of 12000 participants. Acne vulgaris affects 9% of the population worldwide, 85% are between 12-24 years. Characters such as age and sex may vary among different studies. Many papers demonstrate the effect of demographic factors. Reaching late teenage can decrease its prevalence, and eruption is higher in females compared to male. Topical retinoid and benzoyl per oxide were effective in reducing inflammatory and non-inflammatory lesions. For mild to moderate acne pharmacological treatment, chemical, antibiotic and photodynamic therapy are among most effective. Oral antibiotics while effective, have raised concerned about resistance. For moderate to severe, the most effective one is oral Isotretinoin and photodynamic treatment. Most of us already know too much about this topic. Its 8th commonest disease known globally. It has many treatments. It’s the cause of social withdrawal and depression. In this case it is important to know about the causes that shift non inflammatory to inflammatory ones. Dermatologists are trying their best in combination of multiple therapies to treat it successfully. Personalized treatment plans considering patient-specific factors, such as acne severity, patient preference and risk of adverse effects, are essential for optimal management.

New clinical approach in facial mild-moderate acne: Re-stabilization of skin microbiota balance with a topical biotechnological phytocomplex.

Dysbiosis of the skin microbiota has been identified as a key factor in the development of acne. This study was aimed to evaluate the effect of a facial cream gel containing a biotechnological phytocomplex, niacinamide and succinic acid on the bacterial diversity of subjects with mild-moderate acne and its clinical benefits due to microbiota changes. Open-label, clinical study in 44 subjects with mild-moderate acne treated with a facial cream gel for 8 weeks. Bacterial diversity was analyzed by 16S rRNA gene sequencing of skin samples. Clinical effects were evaluated using the IGA acne severity scale, biometric measurements, and safety. After 56 days of product's use, an increase in alpha and beta diversity was found (p < 0.01), with a decrease in the relative abundance of C. acnes (48.99% vs. 38.83%, p < 0.001). Regarding clinical results, a decrease in acne severity on the IGA scale (27.33%, p < 0.001), number of non-inflammatory and inflammatory lesions (respectively: 31.12%, p = 0.05; 42.27%, p < 0.001), amount of sebum (89.00%, p < 0.01) and erythema (15.35%, p < 0.01), was found. Responder analysis of the IGA score showed that 61.36% of patients improved by at least one point at day 56. The product was well tolerated throughout the study. The use of the facial cream gel on skin was effective in rebalancing the microbiota, inhibiting biofilm formation and other virulence factors, reducing the number of mild-moderate acne lesions and sebum secretion, and consequently improving acne's severity.

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.

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.

A Novel Treatment of Acne Vulgaris Using a 1927 nm Fractional Thulium Laser: A Case Series.

Acne vulgaris remains one of the most common and problematic dermatological conditions. Recently, a fractional 1927 nm thulium laser has been developed with specific water absorption characteristics which may be of interest in the treatment of acne. Nine consecutive Korean subjects, 6 females and 3 males, ages ranging from 13 to 33 yr, presented with a mixture of inflammatory and noninflammatory acne. Baseline clinical photography, image analysis and lesion counts were performed. A fractional 1927 nm thulium laser (FTL) delivered 6 treatment sessions in 5 subjects and 5 sessions in 4 subjects, 4 weeks between sessions. Pain during treatment was assessed. At 32 weeks after the last treatment session, an independent Investigator Global Assessment (IGA) performed lesion counts and graded the severity of the acne at baseline and the final assessment on a quintile scale. Data were analyzed statistically. All 9 subjects completed the study with significant reductions in the inflammatory and noninflammatory lesions (P values 0.0012 and 0.0081, respectively) with overall lesion counts at the final assessment ranging from 60% to 97.1%, and acne grades in the IGA dropping by an average of 1.67 (range 1 to 3 grades). There was no significant difference in lesion counts or acne grades between the subjects who had 6 treatments and those who had 5 (P = 0.7695). Mild pain was reported during treatment, and no adverse events were reported by either the subjects or investigator. The FTL at the parameters used in the present study caused disruption to the upper portion of the affected follicles and sebaceous glands under an intact stratum corneum, thereby destroying or damaging the causative Cutibacterium acnes. The superficial controlled coagulation additionally induced follicular remodeling and tissue regeneration, potentially contributing to the noticeable results in inflammatory and noninflammatory acne lesions.

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.

Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: Comparison of 4 Clinical Trials

Introduction: Combination therapies targeting multiple processes of acne pathogenesis are recommended for most acne patients. A three-pronged approach using an antibiotic, retinoid, and antibacterial may also increase treatment efficacy versus monotherapy or dual-combination products. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (BPO) polymeric mesh gel (CAB) is the first fixed-dose, triple-combination topical approved by the FDA for the treatment of acne. The objective of this analysis was to compare treatment success and effect size of once-daily CAB with its three constituent dyad gels, branded adapalene 0.3%/BPO 2.5% gel, and vehicle across four clinical studies. Methods: Two phase 2 (NCT03170388, NCT04892706) and two phase 3 (NCT04214652, NCT04214639) double-blind, randomized, 12-week studies enrolled participants with moderate-to-severe acne. In all studies, treatment success at week 12 (defined as a ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) was a co-primary endpoint. Other co-primary endpoints (reduction from baseline in inflammatory and noninflammatory lesions) are not shown here. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. A post hoc analysis of number needed to treat (NNT)—the number of patients who need to be treated with an intervention for one additional patient to achieve success versus vehicle—was performed to provide an additional measure of treatment effect and to indirectly compare data across studies. Results: Across studies, approximately half of CAB-treated participants achieved treatment success by week 12 (range: 49.6-52.5%) versus less than one-fourth with vehicle (range: 8.1%-24.9%; P&lt;0.01, all) and less than one-third with component dyads or branded adapalene 0.3%/BPO 2.5% (range: 27.8%-32.9%; P≤0.001, all). Treatment success rates were significantly greater for all active treatments versus vehicle (P&lt;0.01, all). NNT values for CAB (3-5) were lower (better) than for constituent dyads (5-6) or branded adapalene 0.3%/BPO 2.5% (7), further indicative of greater efficacy. TEAEs with CAB were mostly of mild-to-moderate severity. TEAE and discontinuation rates were similar or lower with CAB gel than with adapalene/BPO dyad gels. Mean cutaneous safety/tolerability scores with CAB gel were &lt;1 (mild) at all timepoints. Conclusions: CAB gel demonstrated significantly greater efficacy in the treatment of moderate-to-severe acne than dyad gels and branded adapalene 0.3%/BPO 2.5% gel, with approximately half of participants achieving clear/almost clear skin by 12 weeks with CAB. Due to acne pathogenesis, a triple-combination treatment may result in clinical success more often than two-ingredient combination products. Funding: Ortho Dermatologics.

Impact of Age on Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants with Moderate-to-Severe Acne

Introduction: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose, triple-combination formulation approved for the treatment of acne. In three clinical studies of participants with moderate-to-severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. As acne pathogenesis and treatment outcomes can vary with age, this post hoc analysis was performed to evaluate the efficacy and safety of CAB in pediatric and adolescent participants (aged 9-24 years) versus adult participants (≥25 years). This age cutoff was chosen as acne in patients aged 18-24 years is more similar to adolescents than adults, and age 25 is often used to define “adult acne”. Methods: In a phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) studies, participants aged ≥9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (defined as ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts at week 12. Treatment-emergent adverse events (TEAEs) were also assessed. Pooled data across all three studies were analyzed for participants aged 9-24 years (CAB: n=297; vehicle: n=218) or ≥25 years (n=91; n=51). Results: At week 12, approximately half of CAB-treated participants in both age groups achieved treatment success (9-24 years: 50.6%; ≥25: 49.0%) versus less than one-fourth with vehicle (15.7% and 20.6%; P&lt;0.01, both). Treatment with CAB resulted in &gt;70% reductions from baseline in inflammatory and noninflammatory lesions in both age groups, versus 45%-62% with vehicle (P≤0.001, all). There were no significant differences between CAB-treated participants in the two age groups across any of these efficacy endpoints (P=0.68-0.97). Most TEAEs with CAB were of mild-moderate severity, with no age-related trends in safety/tolerability. Conclusions: Fixed-dose, triple-combination CAB gel was efficacious and well tolerated in participants with moderate-to-severe acne, regardless of age. Approximately half of pediatric/adolescent and adult participants achieved clear/almost clear skin with CAB, and lesion count reductions of &gt;70% were observed. Funding: Ortho Dermatologics

Exploring the potential of omega-3 fatty acids in acne patients: A prospective intervention study.

Omega-3 fatty acids (ω-3 FA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA), are essential nutrients known for their anti-inflammatory properties, which involve reducing pro-inflammatory cytokines, eicosanoids, and insulin-like growth factor-1. This suggests their potential to alleviate acne severity, especially when deficits are present. To elevate EPA/DHA levels in acne patients through dietary intervention and supplementation, observing subsequent clinical effects. Over 16 weeks, 60 patients without prescription medication (n = 23 acne comedonica [AC], n = 37 acne papulopustulosa [AP]) adhered to a Mediterranean diet, incorporating oral algae-derived ω-3 FA supplementation (600 mg DHA/300 mg EPA week 1-8, 800 mg DHA/400 mg EPA week 8-16). At four visits (V1-V4), blood EPA/DHA levels were tracked using the HS-omega 3 index® (EPA/DHA (%) of total identified fatty acids in erythrocytes; target 8%-11%, deficit <8%, severe deficit <4%), alongside clinical assessments and standardized questionnaires. At baseline, 98.3% of patients had an EPA/DHA deficit, with the mean HS-omega 3 index® rising from 4.9% at V1 to 8.3% at V4 (p < 0.001). AC showed significantly higher indices than AP at V4 (p = 0.035). Objective improvements in both inflammatory and non-inflammatory lesions were observed (p < 0.001). While self-reported appearance worsened in four patients, overall quality of life improved (p < 0.001), particularly in AP. Dietary triggers were more clearly defined than beneficial foods. Intake of cow's milk and dairy products reduced (p < 0.001). Compliance was good; no adverse events were reported. Many acne patients have a ω-3 FA deficit. The HS-omega 3 index® can be increased by a Mediterranean diet and oral supplementation with algae-derived ω-3 FA. Acne severity improved significantly in patients with target ω-3 FA levels.