Acne VulgarisCHARMNCT07205107
Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris
An observational study of Acne Vulgaris, run by Bausch Health Americas, Inc. at 19 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- clindamycin phosphate, adapalene and benzoyl peroxide
- How many people
- 200 participants
- Where
- 19 sitesCanada
- Study dates
- 2 Oct 2025to 3 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Canadian routine clinical practice
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Canada19 sites
CHARM Site 007
Calgary, Alberta, T2J 7E1
CHARM Site 001
Edmonton, Alberta, T6W 0J5
CHARM Site 021
Hamilton, Ontario, L8P 4B4
CHARM Site 010
Markham, Ontario, L3P 1X3
CHARM Site 008
Montreal, Quebec, H1Y 3L1
CHARM Site 013
Newmarket, Ontario, L3Y 5G8
CHARM Site 022
North York, Ontario, M3B 0A7
CHARM Site 015
Ottawa, Ontario, K1V 7Z5
CHARM Site 006
Pointe-Claire, Quebec, H9R 5M7
CHARM Site 018
Québec, Quebec, G1W 4R4
CHARM Site 011
Richmond Hill, Ontario, L4B 1L1
CHARM Site 017
Surrey, British Columbia, V3V 0C6
CHARM Site 016
Toronto, Ontario, M2N 3A6
CHARM Site 005
Toronto, Ontario, M4E 1R7
CHARM Site 014
Toronto, Ontario, M4W 2N2
CHARM Site 002
Toronto, Ontario, M5A 3R6
CHARM Site 012
Vancouver, British Columbia, V5Z 1H2
CHARM Site 019
Windsor, Ontario, N8W 5L7
CHARM Site 003
Winnipeg, Manitoba, R3M 3Z4
About this study
Official title: 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)
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.
Read the 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 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.
- Conditions
- Acne Vulgaris
- Being tested
- clindamycin phosphate, adapalene and benzoyl peroxide
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clindamycin phosphate, adapalene and benzoyl peroxideDrug
Also called CABTREO, IDP-126, Clindamycin Phosphate (1.2% w/w), Adapalene (0.15% w/w) and Benzoyl Peroxide (3.1% w/w)
Topical treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction at Week-12 as assessed by DermSat-7
To describe treatment satisfaction of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel at Week-12 in patients with acne vulgaris in Canadian routine clinical practice, using mean DermSat-7 domain scores. The DermSat-7 is a dermatology-specific, 7-item questionnaire used to assess patient satisfaction with treatment across three domains: effectiveness, convenience, and overall satisfaction. Domain scores are transformed to a linear 0-100 scale, with higher scores indicating greater satisfaction.
Measured: Week 12
Secondary outcomes (9)
Treatment Satisfaction at Week-4, Week-8 and Week-20 as assessed by DermSat-7
To describe treatment satisfaction of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel at Week-4, Week-8 and Week-20 in patients with acne vulgaris in Canadian routine clinical practice, using mean DermSat-7 domain scores. The DermSat-7 is a dermatology-specific, 7-item questionnaire used to assess patient satisfaction with treatment across three domains: effectiveness, convenience, and overall satisfaction. Domain scores are transformed to a linear 0-100 scale, with higher scores indicating greater satisfaction.
Measured: Week 4, Week 8 and Week 20
Change from Baseline in Treatment Satisfaction at Week-12 as assessed by DermSat-7
To describe change in treatment satisfaction at Week-12 following clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel initiation in patients with acne vulgaris in Canadian routine clinical practice, using mean DermSat-7 domain scores. The DermSat-7 is a dermatology-specific, 7-item questionnaire used to assess patient satisfaction with treatment across three domains: effectiveness, convenience, and overall satisfaction. Domain scores are transformed to a linear 0-100 scale, with higher scores indicating greater satisfaction.
Measured: Baseline and Week-12
Treatment Adherence at Week-4, Week-8, Week-12, and Week-20
To describe treatment adherence to clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel in patients with acne vulgaris in Canadian routine clinical practice, as captured in a daily electronic diary using percentage of patients who achieve at least 80% treatment adherence at Week-4, Week-8, Week-12, and Week-20 from treatment initiation.
Measured: From Baseline to Week-20
Treatment Effectiveness as assessed by mean change from baseline in Investigator Global Assessment (IGA) score
To describe the effectiveness of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel in patients with acne vulgaris in Canadian routine clinical practice, as assessed by mean change in IGA score at Week-12 and Week-20 from baseline. The IGA is a 5-point scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe), with higher scores indicating worse acne severity.
Measured: Baseline, Week-12, and Week-20
Treatment Effectiveness as assessed by mean Investigator Global Assessment (IGA) score
To describe the effectiveness of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel in patients with acne vulgaris in Canadian routine clinical practice, as assessed by mean IGA score at baseline, Week-12, and Week-20. The IGA is a 5-point scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe), with higher scores indicating worse acne severity.
Measured: Baseline, Week-12, and Week-20
Treatment Effectiveness as assessed by percentage of patients achieving at least a 1-grade improvement in Investigator Global Assessment (IGA) score
To describe the effectiveness of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel in patients with acne vulgaris in Canadian routine clinical practice, as assessed by the percentage of patients who have achieved at least a 1-grade improvement at Week-12 and Week-20 from baseline. The IGA is a 5-point scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe), with higher scores indicating worse acne severity.
Measured: Baseline, Week-12, and Week-20
Treatment Effectiveness as assessed by number and percentage of patients achieving a score of 0 to 1 in Investigator Global Assessment (IGA) score
To describe the effectiveness of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel in patients with acne vulgaris in Canadian routine clinical practice, as assessed by number and percentage of patients who achieve IGA = 0 to 1 at Week-12 and Week-20. The IGA is a 5-point scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe), with higher scores indicating worse acne severity.
Measured: Week-12, and Week-20
Safety and Tolerability
To describe the safety and tolerability of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel in patients with acne vulgaris in Canadian routine clinical practice, with number and percentage of adverse events (AEs) and serious AEs (SAEs) reported over 20 weeks, and number and percentage of patients who discontinued due to an AE or SAE at Week-20.
Measured: From baseline to Week-20
Health State Utility as assessed by Health Utility Index 2 (HUI2)
To describe the health state utility scores in patients with acne vulgaris treated with clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel in Canadian routine clinical practice, as per percentage change in Health Utility Index 2 (HUI2) score at Week-12 and Week-20 from baseline, and mean HUI2 score at baseline, Week-12, and Week-20.
Measured: Baseline, Week-12, and Week-20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start2 Oct 2025
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronique Gaudet, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205107
- Sponsor's protocol ID
- BHC-CAN-DERM-004
- Acronym
- CHARM
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07205107
- Acronym / sponsor ID
- CHARM / BHC-CAN-DERM-004
- Conditions
- Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Canadian routine clinical practice
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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, 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clindamycin phosphate, adapalene and benzoyl peroxideAlso: CABTREO, IDP-126, Clindamycin Phosphate (1.2% w/w), Adapalene (0.15% w/w) and Benzoyl Peroxide (3.1% w/w)Topical treatment | Drug | – |
Primary outcome
Treatment Satisfaction at Week-12 as assessed by DermSat-7
Time frame: Week 12
To describe treatment satisfaction of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel at Week-12 in patients with acne vulgaris in Canadian routine clinical practice, using mean DermSat-7 domain scores. The DermSat-7 is a dermatology-specific, 7-item questionnaire used to assess patient satisfaction with treatment across three domains: effectiveness, convenience, and overall satisfaction. Domain scores are transformed to a linear 0-100 scale, with higher scores indicating greater satisfaction.
9 secondary outcomes
Treatment Satisfaction at Week-4, Week-8 and Week-20 as assessed by DermSat-7
Time frame: Week 4, Week 8 and Week 20
Change from Baseline in Treatment Satisfaction at Week-12 as assessed by DermSat-7
Time frame: Baseline and Week-12
Treatment Adherence at Week-4, Week-8, Week-12, and Week-20
Time frame: From Baseline to Week-20
Treatment Effectiveness as assessed by mean change from baseline in Investigator Global Assessment (IGA) score
Time frame: Baseline, Week-12, and Week-20
Treatment Effectiveness as assessed by mean Investigator Global Assessment (IGA) score
Time frame: Baseline, Week-12, and Week-20
Treatment Effectiveness as assessed by percentage of patients achieving at least a 1-grade improvement in Investigator Global Assessment (IGA) score
Time frame: Baseline, Week-12, and Week-20
Treatment Effectiveness as assessed by number and percentage of patients achieving a score of 0 to 1 in Investigator Global Assessment (IGA) score
Time frame: Week-12, and Week-20
Safety and Tolerability
Time frame: From baseline to Week-20
Health State Utility as assessed by Health Utility Index 2 (HUI2)
Time frame: Baseline, Week-12, and Week-20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Gaudet study director
Bausch Health Americas, Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Bausch Health Americas, Inc. at 19 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Satisfaction at Week-12 as assessed by DermSat-7 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.