BRIdGE
Research type
Research Study
Full title
Clinical Study to evaluate the efficacy, tolerability, and satisfaction of participants with mild to moderate acne, treated with benzoyl peroxide 5% w/w gel, over 12 weeks, potentially followed by another 12 weeks using an anti-relapse gel, while using a Cleanse, Moisturise and Protect (CTMP) routine throughout the study.
IRAS ID
1011959
Contact name
Charlotte McGowan
Contact email
Sponsor organisation
Galderma SA
Research summary
Acne vulgaris (AV) is a multifactorial skin disease of the pilosebaceous unit, affecting approximately 80% of young adults and adolescents aged 11 to 30. This can cause lesions found on the face. The primary aim of this study is to evaluate the efficacy, tolerability and satisfaction of participants with mild to moderate acne, treated with benzoyl peroxide5 % w/w gel over 12 weeks while using a cleanser, moisturiser, and sun protection SPF 30 (CTMP routine). Participants will be followed up for 12 weeks for part 1 of the study using benzoyl peroxide 5% w/w gel as part of a CTMP routine, with the potential of extending to part 2 for a further 12 weeks using an anti-relapse gel. There will be a total of 8 on-site visits throughout this time period (baseline/screening, week 2, week 4, week 8, week 12/baseline study part 2, week 24 study part 2), 7 if screening and baseline are conducted in the same visit. The participants will also have 3 telephone calls in lieu of an on-site visit.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0094
Date of REC Opinion
14 Apr 2025
REC opinion
Further Information Unfavourable Opinion