Phase
Condition
Rash
Scalp Disorders
Acne
Treatment
clindamycin phosphate, adapalene and benzoyl peroxide
Clinical Study ID
Ages > 12 All Genders
Study Summary
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:
Patients who are hypersensitive to clindamycin phosphate, to adapalene, tobenzoyl peroxide or to any ingredient in the formulation or component of thecontainer,
Patients with a history of regional enteritis (Crohn's disease), ulcerativecolitis, 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, 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
Study Description
Connect with a study center
CHARM Site 007
Calgary, Alberta T2J 7E1
CanadaSite Not Available
CHARM Site 001
Edmonton, Alberta T6W 0J5
CanadaSite Not Available
CHARM Site 001
Edmonton 5946768, Alberta 5883102 T6W 0J5
CanadaSite Not Available
CHARM Site 017
Surrey, British Columbia V3V 0C6
CanadaSite Not Available
CHARM Site 012
Vancouver, British Columbia V5Z 1H2
CanadaSite Not Available
CHARM Site 017
Surrey 6159905, British Columbia 5909050 V3V 0C6
CanadaSite Not Available
CHARM Site 012
Vancouver 6173331, British Columbia 5909050 V5Z 1H2
CanadaSite Not Available
CHARM Site 003
Winnipeg, Manitoba R3M 3Z4
CanadaSite Not Available
CHARM Site 003
Winnipeg 6183235, Manitoba 6065171 R3M 3Z4
CanadaSite Not Available
CHARM Site 021
Hamilton, Ontario L8P 4B4
CanadaSite Not Available
CHARM Site 010
Markham, Ontario L3P 1X3
CanadaSite Not Available
CHARM Site 013
Newmarket, Ontario L3Y 5G8
CanadaSite Not Available
CHARM Site 022
North York, Ontario M3B 0A7
CanadaSite Not Available
CHARM Site 015
Ottawa, Ontario K1V 7Z5
CanadaSite Not Available
CHARM Site 011
Richmond Hill, Ontario L4B 1L1
CanadaSite Not Available
CHARM Site 002
Toronto, Ontario M5A 3R6
CanadaSite Not Available
CHARM Site 005
Toronto, Ontario M4E 1R7
CanadaSite Not Available
CHARM Site 014
Toronto, Ontario M4W 2N2
CanadaSite Not Available
CHARM Site 016
Toronto, Ontario M2N 3A6
CanadaSite Not Available
CHARM Site 019
Windsor, Ontario N8W 5L7
CanadaSite Not Available
CHARM Site 021
Hamilton 5969782, Ontario 6093943 L8P 4B4
CanadaSite Not Available
CHARM Site 010
Markham 6066513, Ontario 6093943 L3P 1X3
CanadaSite Not Available
CHARM Site 013
Newmarket 6087701, Ontario 6093943 L3Y 5G8
CanadaSite Not Available
CHARM Site 015
Ottawa 6094817, Ontario 6093943 K1V 7Z5
CanadaSite Not Available
CHARM Site 011
Richmond Hill 6122091, Ontario 6093943 L4B 1L1
CanadaSite Not Available
CHARM Site 002
Toronto 6167865, Ontario 6093943 M5A 3R6
CanadaActive - Recruiting
CHARM Site 005
Toronto 6167865, Ontario 6093943 M4E 1R7
CanadaActive - Recruiting
CHARM Site 014
Toronto 6167865, Ontario 6093943 M4W 2N2
CanadaSite Not Available
CHARM Site 016
Toronto 6167865, Ontario 6093943 M2N 3A6
CanadaActive - Recruiting
CHARM Site 019
Windsor 6182962, Ontario 6093943 N8W 5L7
CanadaSite Not Available
CHARM Site 008
Montreal, Quebec H1Y 3L1
CanadaSite Not Available
CHARM Site 006
Pointe-Claire, Quebec H9R 5M7
CanadaSite Not Available
CHARM Site 018
Québec, Quebec G1W 4R4
CanadaSite Not Available
CHARM Site 008
Montreal 6077243, Quebec 6115047 H1Y 3L1
CanadaSite Not Available
CHARM Site 006
Pointe-Claire 6107325, Quebec 6115047 H9R 5M7
CanadaSite Not Available
CHARM Site 018
Québec 6325494, Quebec 6115047 G1W 4R4
CanadaSite Not Available

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