Dataset Information

Twelve-week, multicenter, placebo-controlled, randomized, double-blind, parallel-group, comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication.

ABSTRACT: A placebo-controlled, randomized, double-blind, parallel-group, comparative, multicenter study was conducted to investigate the efficacy and safety of benzoyl peroxide (BPO) gel, administrated once daily for 12 weeks to Japanese patients with acne vulgaris. Efficacy was evaluated by counting all inflammatory and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. All 609 subjects were randomly assigned to receive the study products (2.5% and 5% BPO and placebo), and 607 subjects were included in the full analysis set, 544 in the per protocol set and 609 in the safety analyses. The median rates of reduction from baseline to the last evaluation of the inflammatory lesion counts, the primary end-point, in the 2.5% and 5% BPO groups were 72.7% and 75.0%, respectively, and were significantly higher than that in the placebo group (41.7%). No deaths or other serious adverse events were observed. The incidences of adverse events in the 2.5% and 5% BPO groups were 56.4% and 58.8%, respectively; a higher incidence than in the placebo group, but there was no obvious difference between the 2.5% and 5% BPO groups. All adverse events were mild or moderate in severity. Most adverse events did not lead to study product discontinuation. The results suggested that both 2.5% and 5% BPO are useful for the treatment of acne vulgaris.

SUBMITTER: Kawashima M

PROVIDER: S-EPMC5516201 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Twelve-week, multicenter, placebo-controlled, randomized, double-blind, parallel-group, comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication.

Kawashima Makoto M Sato Shinichi S Furukawa Fukumi F Matsunaga Kayoko K Akamatsu Hirohiko H Igarashi Atsuyuki A Tsunemi Yuichiro Y Hayashi Nobukazu N Yamamoto Yuki Y Nagare Toshitaka T Katsuramaki Tsuneo T

The Journal of dermatology 20170311 7

A placebo-controlled, randomized, double-blind, parallel-group, comparative, multicenter study was conducted to investigate the efficacy and safety of benzoyl peroxide (BPO) gel, administrated once daily for 12 weeks to Japanese patients with acne vulgaris. Efficacy was evaluated by counting all inflammatory and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. All 609 subjects were randomly assigned to receive the ...[more]

PMID: 28295516

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:BackgroundCutibacterium acnes is a common pathogen leading to postoperative shoulder infections. Many centers are utilizing 5% topical benzoyl peroxide (BPO) gel to decrease cutibacterium acnes bioburden prior to surgery. The purpose of this study was to evaluate patient compliance, tolerance, and side effects of applying BPO to the shoulder prior to surgery. Our hypothesis was that BPO would be well tolerated with few, minor side effects, and patients would comply with a regimen of 5 treatments spanning 48 hours prior to surgery.MethodsAll patients undergoing operative intervention, either open or arthroscopic, about the shoulder from August 7, 2020, through July 15, 2021, by a single surgeon were instructed to apply BPO to the shoulder after showering, on dry skin, in the morning and evening, starting 48 hours before their surgical date. Patients were instructed to apply a half-dollar-sized quantity for each treatment. There were a total of 5 topical applications. On the day of surgery, patients were given a 6-question survey regarding side effects experienced, BPO treatments missed, ease of treatment, and a scenario question. Demographic information was collected, and a satisfaction survey was administered upon study completion.ResultsA total of 183 patients out of a possible 284 eligible patients (64.4%) completed the survey. The median (interquartile range) age at surgery was 59.9 years. Sixty-four participants (35%) in the study cohort were female. One-hundred thirteen (61.7%) had an arthroscopic surgical approach, whereas 70 (38.3%) underwent open shoulder surgery. Most patients (N = 152, 83.5%) experienced no side effects from the topical 5% BPO gel treatments. Twenty-two (12.0%) patients missed 1 treatment, 10 (5.5%) missed 2 treatments, 1 (0.5%) missed 3 treatments, 3 (1.6%) missed 4 treatments, and 4 (2.2%) missed all 5 treatments. The majority of patients, 143 (78.1%), completed all 5 treatments. When prompted to choose between serial skin preparation treatments at home leading up to surgery or a single light-based decolonization procedure in the preoperative holding area on the day of surgery, 111 (60.7%) preferred to undergo antimicrobial treatment at home and arrive for surgery as otherwise scheduled.ConclusionSerial preoperative applications of topical 5% BPO gel are well tolerated by the majority of patients. Over 20% of patients missed at least one application of BPO. Most patients prefer home-based antimicrobial treatments compared with arriving earlier on the day of surgery for a single light-based antimicrobial treatment.

Project description:BackgroundVery few clinical trials have investigated the effect of topical acne treatment on scarring.ObjectivesOur 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.MethodsIn 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.ResultsIncluded 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 < 0.0001). For SGA at week 24, a total of 32.9% with A0.3/BPO2.5 versus 16.4% with vehicle (p < 0.01) were clear/almost clear. Inflammatory acne lesions decreased by 86.7% for A0.3/BPO2.5 versus 57.9% for vehicle (p < 0.0001), and 64.2 versus 19.4% of subjects, respectively, were IGA clear/almost clear (p < 0.0001) at week 24. Treatment-related AEs were reported by 20.9% for A0.3/BPO2.5 versus 9% for vehicle side, most commonly skin irritation (14.9 vs. 6%, respectively).ConclusionsTopical A0.3/BPO2.5 prevented and reduced atrophic scar formation. Scar count increased with vehicle (+ 14.4%) but decreased with A0.3/BPO2.5 (- 15.5%) over 24 weeks.Trial registryClinicalTrials.gov identifier NCT02735421.

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.

Dataset Information

Twelve-week, multicenter, placebo-controlled, randomized, double-blind, parallel-group, comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication.

Publications

Twelve-week, multicenter, placebo-controlled, randomized, double-blind, parallel-group, comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets