Dataset Information

Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison.

ABSTRACT: Very few clinical trials have investigated the effect of topical acne treatment on scarring.Our objective was to evaluate the efficacy of adapalene 0.3%/benzoyl peroxide 2.5% gel (A0.3/BPO2.5) in atrophic acne scar formation in patients with acne.In this multicenter, randomized, investigator-blinded, vehicle-controlled study, subjects with moderate or severe facial acne (Investigator's Global Assessment [IGA] score 3 or 4; ??25 inflammatory lesions; ten or more atrophic acne scars) applied A0.3/BPO2.5 or vehicle daily per half face for 24 weeks. Subjects with acne requiring systemic treatment were excluded. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA), acne lesion count, IGA, skin roughness and skin texture, subject self-assessment of clinical acne-related scars and satisfaction questionnaire, tolerability, and safety.Included subjects (n?=?67) had mainly moderate acne (92.5% IGA 3); mean scores at baseline were approximately 40 acne lesions and 12 scars per half face. By week 24, the change from baseline in total scar count was -?15.5% for A0.3/BPO2.5 versus ?+ 14.4% for vehicle (approximately 30% difference), with a mean of 9.5 scars versus 13.3 per half face, respectively (p?

SUBMITTER: Dreno B

PROVIDER: S-EPMC5978908 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison.

Dréno Brigitte B Bissonnette Robert R Gagné-Henley Angélique A Barankin Benjamin B Lynde Charles C Kerrouche Nabil N Tan Jerry J

American journal of clinical dermatology 20180401 2

<h4>Background</h4>Very few clinical trials have investigated the effect of topical acne treatment on scarring.<h4>Objectives</h4>Our objective was to evaluate the efficacy of adapalene 0.3%/benzoyl peroxide 2.5% gel (A0.3/BPO2.5) in atrophic acne scar formation in patients with acne.<h4>Methods</h4>In this multicenter, randomized, investigator-blinded, vehicle-controlled study, subjects with moderate or severe facial acne (Investigator's Global Assessment [IGA] score 3 or 4; ≥ 25 inflammatory l ...[more]

PMID: 29549588

Similar Datasets

Project description:A need exists for topical treatments in managing more severe inflammatory acne.The objectives of this study were to evaluate the efficacy and safety of adapalene 0.3 %/benzoyl peroxide 2.5 % (0.3 % A/BPO) topical gel in subjects with moderate and severe inflammatory acne.This was a multicenter, randomized, double-blind, parallel-group study. Randomization was stratified by acne severity (50 % moderate and 50 % severe). Subjects received 0.3 % A/BPO, 0.1 % A/BPO (benchmark), or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (the percentage of subjects rated 'clear' or 'almost clear' with at least a 2-grade improvement on Investigator's Global Assessment [IGA]) and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms.A total of 503 subjects were randomized: 217, 217, and 69 subjects in the 0.3 % A/BPO, 0.1 % A/BPO, and vehicle groups, respectively. For success rate (subjects rated 'clear' or 'almost clear' with ?2-grade improvement in IGA), 0.3 % A/BPO was superior to vehicle, with a treatment difference of 22.7 % (33.7 vs. 11.0 %; 95 % confidence interval [CI] 12.8-32.6, p < 0.001). At week 12, 0.3 % A/BPO was superior to vehicle for mean reduction from baseline in IN (27.0 vs. 14.4) and NIN lesion counts (40.2 vs. 18.5), as well as for percentage reduction from baseline in IN (68.7 vs. 39.2 %) and NIN lesion counts (68.3 vs. 37.4 %) (all p < 0.001). Among subjects with severe inflammatory acne (IGA = 4), 0.1 % A/BPO did not reach statistical significance for success rate compared with vehicle (p = 0.443), whereas 0.3 % A/BPO demonstrated significantly greater efficacy (p = 0.029, requiring ?3-point IGA improvement). Additionally, 0.3 % A/BPO was safe and well-tolerated.Results of this clinical trial demonstrate the significantly greater efficacy of adapalene 0.3 % A/BPO topical gel compared with vehicle as well as a good safety profile in the treatment of moderate to severe inflammatory non-nodulocystic acne, which increases patients' treatment options. CLINICALTRIALS.NCT01880320.

Project description:BackgroundA gel combination treatment containing a retinoid (adapalene 0.1%) and an antimicrobial (benzoyl peroxide 2.5%) has been shown to be an effective treatment for acne vulgaris, addressing three of the four pathogenic factors (hyperkeratinization, Propionibacterium acnes proliferation, inflammation) without contributing to the incidence of Propionibacterium acnes antibiotic resistance as neither the retinoid nor benzoyl peroxide creates selective pressure for resistance.ObjectiveTo evaluate the effectiveness of an adapalene-benzoyl peroxide gel combination in reducing antibiotic-sensitive and resistant strains of Propionibacterium acnes on the facial skin of volunteers.MethodsThis four-week, open-label, single-center study included 30 healthy adults with high facial Propionibacterium acnes populations [>10(4) colony-forming units per square centimeter of skin (CFU/cm(2))] and presence of subpopulations resistant to erythromycin, tetracycline, and clindamycin. The gel was applied once daily to the forehead. Cultures for total and antibiotic-resistant Propionibacterium acnes were obtained from the forehead area at screening, Baseline, Week 2, and Week 4.ResultsTotal Propionibacterium acnes counts decreased by 1.1 log(10) CFU/cm(2) after two weeks of treatment, and by 1.6 log10 CFU/cm(2) after four weeks. All subjects had strains resistant to each of the five antibiotics at baseline. Mean counts of erythromycin and clindamycin resistant Propionibacterium acnes were high at baseline (5.37 and 5.28 log(10) CFU/cm(2), respectively) and decreased by ≥2.1 log(10) by Week 4 (P<0.001). Mean counts of strains resistant to tetracyclines were lower at baseline (3.8 to 4.2 CFU/cm(2)) and decreased by 1.9 (tetracycline), 2.4 (minocycline), and 1.3 (doxycycline) log(10) CFU/cm(2) by Week 4 (P<0.001).LimitationsAlthough limited in scope, the results of the present study demonstrate that the fixed-dose combination gel containing adapalene 0.1% and benzoyl peroxide 2.5% effectively inhibited both antibiotic-susceptible and antibiotic-resistant Propionibacterium acnes. In addition to reducing population densities, therapy with adapalene-benzoyl peroxide eradicated some resistant strains entirely in some individual subjects.ConclusionTopical adapalene-benzoyl peroxide gel effectively reduced skin colonization by antibiotic-sensitive and antibiotic-resistant Propionibacterium acnes after four weeks. This trial was registered with ClinicalTrials.gov (http://clinicaltrials.gov/), registry number NCT00907101.

Project description:IntroductionPoor adherence to acne treatment may lead to unnecessary treatments, increased healthcare costs, and reduced quality of life (QoL). This multicenter study evaluated the effect of supplementary patient education material (SEM) (a short video, information card, and additional information available online) on treatment adherence and satisfaction among acne patients treated with the fixed-dose combination adapalene 0.1%/benzoyl peroxide 2.5% gel (A/BPO) in primary care clinics versus (1) standard-of-care patient education (SOCPE) (package insert and oral instruction) and (2) SOCPE plus more frequent clinic visits.MethodsSubjects with acne were randomized to receive once-daily A/BPO for 12 weeks plus (1) SEM in addition to SOCPE; (2) SOCPE only with two additional visits; or (3) SOCPE only. Other assessments included a subject appreciation questionnaire, a physician questionnaire, and safety.ResultsNinety-seven subjects were enrolled. At baseline, most (87.6%) had mild to moderate acne. Better adherence was observed in the A/BPO + SEM group compared with A/BPO + more visits or A/BPO alone [mean 63.1%, 48.2% (p = 0.0206), and 56.5%, respectively]. The A/BPO + SEM group had more subjects with greater than 75% adherence (45%, 30.4%, and 25%, respectively). According to the subject appreciation questionnaire, the SEM was more helpful to adhere to treatment (56.7%) versus more visits (32.3%) and A/BPO alone (15.2%), better use the product (70%, 61.3%, and 54.5%, respectively), and better manage skin irritation (53.3%, 48.4%, and 36.4%, respectively). All physicians were satisfied with the SEM and 90% would consider using it in their practice. Safety assessment showed fewer treatment-related adverse events in the A/BPO + SEM group.ConclusionUse of the SEM may increase adherence of acne patients treated with once-daily A/BPO gel in primary care, consequently improving treatment and QoL in the long term.FundingNestle Skin Health-Galderma R&D.Trial registrationClinicalTrials.gov Identifier: NCT02307266.

Project description:BackgroundA three-pronged approach to acne treatment-combining an antibiotic, antibacterial, and retinoid-could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance.ObjectivesWe aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel for the treatment of acne.MethodsIn a phase II, double-blind, multicenter, randomized, 12-week study, eligible participants aged ≥ 9 years with moderate-to-severe acne were equally randomized to once-daily IDP-126, vehicle, or one of three component dyad gels: BPO/adapalene; clindamycin phosphate/BPO; or clindamycin phosphate/adapalene. Coprimary endpoints were treatment success at week 12 (participants achieving a ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least-squares mean absolute changes from baseline in inflammatory and noninflammatory lesion counts to week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed.ResultsA total of 741 participants were enrolled. At week 12, 52.5% of participants achieved treatment success with IDP-126 vs vehicle (8.1%) and dyads (range 27.8-30.5%; P ≤ 0.001, all). IDP-126 also provided significantly greater absolute reductions in inflammatory (29.9) and noninflammatory (35.5) lesions compared with vehicle or dyads (range inflammatory, 19.6-26.8; noninflammatory, 21.8-30.0; P < 0.05, all), corresponding to > 70% reductions with IDP-126. IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity.ConclusionsOnce-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% gel demonstrated superior efficacy to vehicle and all three dyad component gels, and was well tolerated over 12 weeks in pediatric, adolescent, and adult participants with moderate-to-severe acne.Clinical trial registrationClinicalTrials.gov identifier NCT03170388 (registered 31 May, 2017).

Project description:BackgroundAcne affects more than 80% of adolescents and young adults, who most often develop acne scars. Supporting data on the effect of acne scars on patient's health-related quality of life (HRQOL) are limited.ObjectiveThe aim was to determine how the severity of acne scars impacts the HRQOL of afflicted individuals.MethodsIn this population-based cross-sectional study, 723 adults with facial acne scars but without active acne lesions self-completed the Self-assessment of Clinical Acne-Related Scars (SCARS) questionnaire formulated to investigate degree of acne scarring. The Facial Acne Scar Quality of Life (FASQoL), Dermatology Life Quality Index (DLQI), and Dysmorphic Concern Questionnaire (DCQ) were completed to assess the attitude of these patients toward their scars and the impact of scarring on their HRQOL.ResultsThe mean (standard error) DLQI score for facial acne scars was 6.26 (0.22). Acne scars were considered a 'very large' or 'extremely large' concern by 19.3% of participants with mild scars as compared to 20.1% and 34.0% of participants with moderate and severe/very severe scars, respectively (P = 0.003). Higher FASQoL scores were associated with increased severity of scarring (P = 0.001). In total, 16.9% of participants had clinical features of dysmorphia (i.e., DCQ > 13). DCQ scores were significantly higher among participants with more severe scarring (mean DCQ score of 8.04 [0.28], 8.40 [0.18], and 10.13 [0.08] among participants with mild, moderate, and severe/very severe acne scars, respectively; P = 0.001). Most commonly reported signs of emotional distress were self-consciousness (68.0%) and worry about scars not going away (74.8%).ConclusionsThis study highlights the significant psychosocial impact of atrophic acne scars in the form of embarrassment and self-consciousness. Individuals with mild scars also expressed significant impact on quality of life that increased with aggravation of scar severity. Patient-reported outcomes provide an insight into the physical, functional, and psychological impact of acne scarring from the patient's perspective.

Dataset Information

Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison.

Publications

Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets