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

Bausch Health

Status: Enrolling

Conditions: Acne Vulgaris

Treatments: Drug: clindamycin phosphate, adapalene and benzoyl peroxide

Study type: Observational

Funder types: Industry

Identifiers

NCT07205107

BHC-CAN-DERM-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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, 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.