Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris
NCT ID: NCT07205107
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-10-02
2026-08-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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clindamycin phosphate, adapalene and benzoyl peroxide
Topical treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
1. Patients who are hypersensitive to clindamycin phosphate, to adapalene, to benzoyl peroxide or to any ingredient in the formulation or component of the container,
2. Patients with a history of regional enteritis (Crohn's disease), ulcerative colitis, or antibiotic-associated colitis, and/or
3. 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.
12 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Veronique Gaudet
Role: STUDY_DIRECTOR
Bausch Health, Canada Inc.
Locations
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CHARM Site 001
Edmonton, Alberta, Canada
CHARM Site 012
Vancouver, British Columbia, Canada
CHARM Site 003
Winnipeg, Manitoba, Canada
CHARM Site 021
Hamilton, Ontario, Canada
CHARM Site 010
Markham, Ontario, Canada
CHARM Site 013
Newmarket, Ontario, Canada
CHARM Site 022
North York, Ontario, Canada
CHARM Site 015
Ottawa, Ontario, Canada
CHARM Site 011
Richmond Hill, Ontario, Canada
CHARM Site 016
Toronto, Ontario, Canada
CHARM Site 005
Toronto, Ontario, Canada
CHARM Site 014
Toronto, Ontario, Canada
CHARM Site 002
Toronto, Ontario, Canada
CHARM Site 019
Windsor, Ontario, Canada
CHARM Site 008
Montreal, Quebec, Canada
CHARM Site 006
Pointe-Claire, Quebec, Canada
CHARM Site 018
Québec, Quebec, Canada
Countries
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Central Contacts
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Other Identifiers
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BHC-CAN-DERM-004
Identifier Type: -
Identifier Source: org_study_id
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