Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
POWER
Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With 200 mg Doxycycline Capsules Versus Vehicle Gel Associated With Isotretinoin Capsules in the Treatment of Severe Acne
1 other identifier
interventional
266
1 country
25
Brief Summary
Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2011
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 16, 2011
CompletedFirst Posted
Study publicly available on registry
November 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
August 28, 2017
CompletedFebruary 18, 2021
August 1, 2017
1.7 years
November 16, 2011
January 17, 2017
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
Overall success is reached when the 2 following criteria are fulfilled : 1. Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment 2. Safe treatment: Absence of any listed safety issues
20 weeks
Study Arms (2)
Epiduo/Tactuo + doxycycline 200mg
EXPERIMENTALIsotretinoin + vehicle gel
ACTIVE COMPARATORInterventions
oral, 2 capsules once daily in the morning with aglass of water and with food
oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
Eligibility Criteria
You may qualify if:
- Male or female subject of any race, aged 12 to 35 years inclusive
- Subject weighing between 50 and 110 kg
- Subject with severe acne (IGA at least 4), which in the opinion of the investigator is appropriate for treatment with oral isotretinoin (severe nodular acne, severe inflammatory acne, recalcitrant acne; all unresponsive to conventional first line therapies)
- Subject with at least 5 nodules on the face
You may not qualify if:
- Subject with clinically abnormal results to blood testings performed at screening
- Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks
- Female subject who is pregnant, nursing or planning a pregnancy during the study
- Subject with known history of hepatic and/or renal insufficiency, to be confirmed by blood testings
- Subject with known metabolic or structural bone disease (for 12-17 years old population)
- Subject with bowel disease and/or with hypervitaminosis A
- Subject who presents with treated or untreated depression or has a history of depression including a family history of major depression
- Subject with a wash-out period from baseline for topical treatment on the face less than : Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks); Cosmetic procedures (1 week); Photodynamic therapy and laser therapy for acne (3 months)
- Subject with a wash-out period from baseline for systemic treatment less than: Corticosteroids, antibiotics (4 weeks),Progesterone for contraception (3 months); Spironolactone(3 months); Other acne treatments (6 months);Cyproterone acetate(6 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (25)
Galderma investigational site
Ajax, Canada
Galderma investigational site
Barrie, Canada
Galderma investigational site
Calgary, Canada
Galderma investigational site
Edmonton, Canada
Galderma investigational site
Greater Sudbury, Canada
Galderma investigational site
Halifax, Canada
Galderma investigational site
Hamilton, Canada
Galderma investigational site
Markham, Canada
Galderma investigational site
Montreal, Canada
Galderma investigational site
Newmarket, Canada
Galderma investigational site
Oakville, Canada
Galderma investigational site
Oshawa, Canada
Galderma investigational site
Peterborough, Canada
Galderma investigational site
Québec, Canada
Galderma investigational site
Richmond Hill, Canada
Galderma investigational site
Saint-Hyacinthe, Canada
Galderma investigational site
Saskatoon, Canada
Galderma investigational site
St. John's, Canada
Galderma investigational site
Surrey, Canada
Galderma investigational site
Toronto, Canada
Galderma investigational site
Vancouver, Canada
Galderma investigational site
Waterloo, Canada
Galderma investigational site
Windsor, Canada
Galderma investigational site
Winnipeg, Canada
Galderma investigational site
Woodbridge, Canada
Related Publications (1)
Tan J, Humphrey S, Vender R, Barankin B, Gooderham M, Kerrouche N, Audibert F, Lynde C; POWER study group. A treatment for severe nodular acne: a randomized investigator-blinded, controlled, noninferiority trial comparing fixed-dose adapalene/benzoyl peroxide plus doxycycline vs. oral isotretinoin. Br J Dermatol. 2014 Dec;171(6):1508-16. doi: 10.1111/bjd.13191. Epub 2014 Oct 28.
PMID: 24934963DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jerry Tan
- Organization
- University of Western Ontario and Windsor Clinical Research Inc., 2224 Walker Rd. Suite 300, Windsor, ON, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry Tan
Windsor Clinical Research Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2011
First Posted
November 18, 2011
Study Start
November 1, 2011
Primary Completion
July 1, 2013
Study Completion
August 1, 2013
Last Updated
February 18, 2021
Results First Posted
August 28, 2017
Record last verified: 2017-08