Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

Last updated: March 31, 2026
Sponsor: Bausch Health Americas, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rash

Scalp Disorders

Acne

Treatment

clindamycin phosphate, adapalene and benzoyl peroxide

Clinical Study ID

NCT07205107
BHC-CAN-DERM-004
  • Ages > 12
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients who are 12 years or older (unless minors are not permitted as per localregulations) 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 clinicalcare for acne vulgaris but have not yet initiated treatment. The decision toprescribe clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gelmust be made prior to and independent of study participation.

  • Patients and legally authorized representatives who are willing to provide writteninformed consent using an Institutional Review Board (IRB) or Independent EthicsCommittee (IEC)-approved Informed Consent Form (ICF) in English or French. Patientswho 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 clindamycinphosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel.

  • Patients have initiated clindamycin phosphate 1.2% / adapalene 0.15% / benzoylperoxide 3.1% gel within 5 days of signed informed consent/assent.

Exclusion

Exclusion Criteria:

  • Patients who have a contraindication to clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel as per the product monograph:
  1. Patients who are hypersensitive to clindamycin phosphate, to adapalene, tobenzoyl peroxide or to any ingredient in the formulation or component of thecontainer,

  2. Patients with a history of regional enteritis (Crohn's disease), ulcerativecolitis, 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, photodynamictherapy) that could impact study results, as per the investigator's judgement.

  • Patients who have any other serious and/or uncontrolled medical condition, and/orare receiving any medical therapy, that prohibits the patient from participating asper 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 hyperandrogenicstates 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 reportedoutcomes (ePROs) using an electronic device.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: clindamycin phosphate, adapalene and benzoyl peroxide
Phase:
Study Start date:
October 02, 2025
Estimated Completion Date:
August 31, 2026

Study 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 utilization patterns in patients with acne vulgaris who are treated with a topical gel containing clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1% in routine clinical practice across Canada. Approximately 200 patients aged 12 years and older will be enrolled at about 20 dermatology centers.

Connect with a study center

  • CHARM Site 007

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • CHARM Site 001

    Edmonton, Alberta T6W 0J5
    Canada

    Site Not Available

  • CHARM Site 001

    Edmonton 5946768, Alberta 5883102 T6W 0J5
    Canada

    Site Not Available

  • CHARM Site 017

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • CHARM Site 012

    Vancouver, British Columbia V5Z 1H2
    Canada

    Site Not Available

  • CHARM Site 017

    Surrey 6159905, British Columbia 5909050 V3V 0C6
    Canada

    Site Not Available

  • CHARM Site 012

    Vancouver 6173331, British Columbia 5909050 V5Z 1H2
    Canada

    Site Not Available

  • CHARM Site 003

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • CHARM Site 003

    Winnipeg 6183235, Manitoba 6065171 R3M 3Z4
    Canada

    Site Not Available

  • CHARM Site 021

    Hamilton, Ontario L8P 4B4
    Canada

    Site Not Available

  • CHARM Site 010

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • CHARM Site 013

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • CHARM Site 022

    North York, Ontario M3B 0A7
    Canada

    Site Not Available

  • CHARM Site 015

    Ottawa, Ontario K1V 7Z5
    Canada

    Site Not Available

  • CHARM Site 011

    Richmond Hill, Ontario L4B 1L1
    Canada

    Site Not Available

  • CHARM Site 002

    Toronto, Ontario M5A 3R6
    Canada

    Site Not Available

  • CHARM Site 005

    Toronto, Ontario M4E 1R7
    Canada

    Site Not Available

  • CHARM Site 014

    Toronto, Ontario M4W 2N2
    Canada

    Site Not Available

  • CHARM Site 016

    Toronto, Ontario M2N 3A6
    Canada

    Site Not Available

  • CHARM Site 019

    Windsor, Ontario N8W 5L7
    Canada

    Site Not Available

  • CHARM Site 021

    Hamilton 5969782, Ontario 6093943 L8P 4B4
    Canada

    Site Not Available

  • CHARM Site 010

    Markham 6066513, Ontario 6093943 L3P 1X3
    Canada

    Site Not Available

  • CHARM Site 013

    Newmarket 6087701, Ontario 6093943 L3Y 5G8
    Canada

    Site Not Available

  • CHARM Site 015

    Ottawa 6094817, Ontario 6093943 K1V 7Z5
    Canada

    Site Not Available

  • CHARM Site 011

    Richmond Hill 6122091, Ontario 6093943 L4B 1L1
    Canada

    Site Not Available

  • CHARM Site 002

    Toronto 6167865, Ontario 6093943 M5A 3R6
    Canada

    Active - Recruiting

  • CHARM Site 005

    Toronto 6167865, Ontario 6093943 M4E 1R7
    Canada

    Active - Recruiting

  • CHARM Site 014

    Toronto 6167865, Ontario 6093943 M4W 2N2
    Canada

    Site Not Available

  • CHARM Site 016

    Toronto 6167865, Ontario 6093943 M2N 3A6
    Canada

    Active - Recruiting

  • CHARM Site 019

    Windsor 6182962, Ontario 6093943 N8W 5L7
    Canada

    Site Not Available

  • CHARM Site 008

    Montreal, Quebec H1Y 3L1
    Canada

    Site Not Available

  • CHARM Site 006

    Pointe-Claire, Quebec H9R 5M7
    Canada

    Site Not Available

  • CHARM Site 018

    Québec, Quebec G1W 4R4
    Canada

    Site Not Available

  • CHARM Site 008

    Montreal 6077243, Quebec 6115047 H1Y 3L1
    Canada

    Site Not Available

  • CHARM Site 006

    Pointe-Claire 6107325, Quebec 6115047 H9R 5M7
    Canada

    Site Not Available

  • CHARM Site 018

    Québec 6325494, Quebec 6115047 G1W 4R4
    Canada

    Site Not Available

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