Satisfaction, Adherence, Effectiveness, and Safety of Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Treatment in Patients With Acne Vulgaris: A Canadian Prospective Phase IV Study (CHARM)

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Observational
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 aims to answer are: * How satisfied are people with this treatment? * How well do people follow the treatment plan? * How effective and safe is the treatment? * How does the treatment affect quality of life? * How do people use other skin care products, such as cleansers, moisturizers, and sunscreen, while using this treatment? About 200 people aged 12 and older with acne across Canada will use the treatment as part of their regular care and answer questions about their experience over 20 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
CHARM Site 001
RECRUITING
Edmonton
CHARM Site 021
RECRUITING
Hamilton
CHARM Site 010
RECRUITING
Markham
CHARM Site 008
RECRUITING
Montreal
CHARM Site 013
RECRUITING
Newmarket
CHARM Site 022
RECRUITING
North York
CHARM Site 015
RECRUITING
Ottawa
CHARM Site 006
RECRUITING
Pointe-claire
CHARM Site 018
RECRUITING
Québec
CHARM Site 011
RECRUITING
Richmond Hill
CHARM Site 002
RECRUITING
Toronto
CHARM Site 005
RECRUITING
Toronto
CHARM Site 014
RECRUITING
Toronto
CHARM Site 016
RECRUITING
Toronto
CHARM Site 012
RECRUITING
Vancouver
CHARM Site 019
RECRUITING
Windsor
CHARM Site 003
RECRUITING
Winnipeg
Contact Information
Primary
Veronique Gaudet
Veronique.Gaudet@bauschhealth.com
1-800-361-4261
Backup
Maxime Barakat
Maxime.Barakat@bauschhealth.com
1-800-361-4261
Time Frame
Start Date: 2025-10-02
Estimated Completion Date: 2026-08
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Leads: Bausch Health Americas, Inc.

This content was sourced from clinicaltrials.gov