Status:
RECRUITING
Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Brief Summary
The goal of this observational study is to learn about the effects of a treatment that contains clindamycin phosphate, adapalene, and benzoyl peroxide in people with acne. The main questions the study...
Detailed Description
This is a Phase IV, observational, prospective, multi-center study designed to evaluate treatment satisfaction, adherence, effectiveness, safety, tolerability, quality of life, and skin care product u...
Eligibility Criteria
Inclusion
- Patients who are 12 years or older (unless minors are not permitted as per local regulations) who have been prescribed clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel as per the product monograph as part of routine clinical care for acne vulgaris but have not yet initiated treatment. The decision to prescribe clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel must be made prior to and independent of study participation.
- Patients and legally authorized representatives who are willing to provide written informed consent using an Institutional Review Board (IRB) or Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) in English or French. Patients who are less than the age of consent must sign an assent for the study and a parent, or a legal guardian must sign the informed consent.
- Patients who can read, understand, and communicate in English or French.
- Patients must also meet the following additional inclusion criterion at the time of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel initiation in order to be eligible for enrolment in the study:
- Patients have completed IRB or IEC-approved baseline ePROs (DermSat-7 and HUI2) after providing consent and prior to receiving their first dose of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel.
- Patients have initiated clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel within 5 days of signed informed consent/assent.
Exclusion
- Patients who have a contraindication to clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel as per the product monograph:
- Patients who are hypersensitive to clindamycin phosphate, to adapalene, to benzoyl peroxide or to any ingredient in the formulation or component of the container,
- Patients with a history of regional enteritis (Crohn's disease), ulcerative colitis, or antibiotic-associated colitis, and/or
- Pregnant women and women planning a pregnancy.
- Patients who, at the time of informed consent, are clear or almost clear (Investigator Global Assessment \[IGA\] = 0 or 1) or are on current acne therapy (topical or systemic, etc.)), or undergoing procedures (e.g., laser, photodynamic therapy) that could impact study results, as per the investigator's judgement.
- Patients who have any other serious and/or uncontrolled medical condition, and/or are receiving any medical therapy, that prohibits the patient from participating as per the investigator's judgement.
- Patients who have whey protein-triggered acne, drug-induced acne, occupational acne, acne associated with hidradenitis suppurativa or synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome, or acne related to hyperandrogenic states including polycystic ovary syndrome (PCOS).
- Patients who have conditions that mimic acne, including rosacea, folliculitis, perioral dermatitis, demodicosis.
- Patients who are not willing or able to complete electronic patient reported outcomes (ePROs) using an electronic device.
Key Trial Info
Start Date :
October 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07205107
Start Date
October 2 2025
End Date
August 1 2026
Last Update
December 15 2025
Active Locations (17)
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1
CHARM Site 001
Edmonton, Alberta, Canada, T6W 0J5
2
CHARM Site 012
Vancouver, British Columbia, Canada, V5Z 1H2
3
CHARM Site 003
Winnipeg, Manitoba, Canada, R3M 3Z4
4
CHARM Site 021
Hamilton, Ontario, Canada, L8P 4B4