Clinical trial NCT01474590: Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 266
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.


Eligibility criteria: Inclusion Criteria:

1. Male or female subject of any race, aged 12 to 35 years inclusive
2. Subject weighing between 50 and 110 kg
3. 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)
4. Subject with at least 5 nodules on the face

Exclusion Criteria:

1. Subject with clinically abnormal results to blood testings performed at screening
2. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks
3. Female subject who is pregnant, nursing or planning a pregnancy during the study
4. Subject with known history of hepatic and/or renal insufficiency, to be confirmed by blood testings
5. Subject with known metabolic or structural bone disease (for 12-17 years old population)
6. Subject with bowel disease and/or with hypervitaminosis A
7. Subject who presents with treated or untreated depression or has a history of depression including a family history of major depression
8. 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)
9. 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)

Primary outcomes:
measure: The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ajax
country: Canada
facility: Galderma investigational site
city: Barrie
country: Canada
facility: Galderma investigational site
city: Calgary
country: Canada
facility: Galderma investigational site
city: Edmonton
country: Canada
facility: Galderma investigational site
city: Halifax
country: Canada
facility: Galderma investigational site
city: Hamilton
country: Canada
facility: Galderma investigational site
city: Markham
country: Canada
facility: Galderma investigational site
city: Montreal
country: Canada
facility: Galderma investigational site
city: Newmarket
country: Canada
facility: Galderma investigational site
city: Oakville
country: Canada
facility: Galderma investigational site
city: Oshawa
country: Canada
facility: Galderma investigational site
city: Peterborough
country: Canada
facility: Galderma investigational site
city: Quebec city
country: Canada
facility: Galderma investigational site
city: Richmond Hill
country: Canada
facility: Galderma investigational site
city: Saint-Hyacinthe
country: Canada
facility: Galderma investigational site
city: Saint-John's
country: Canada
facility: Galderma investigational site
city: Saskatoon
country: Canada
facility: Galderma investigational site
city: St John's
country: Canada
facility: Galderma investigational site
city: Sudbury
country: Canada
facility: Galderma investigational site
city: Surrey
country: Canada
facility: Galderma investigational site
city: Toronto
country: Canada
facility: Galderma investigational site
city: Vancouver
country: Canada
facility: Galderma investigational site
city: Waterloo
country: Canada
facility: Galderma investigational site
city: Windsor
country: Canada
facility: Galderma investigational site
city: Winnipeg
country: Canada
facility: Galderma investigational site
city: Woodbridge
country: Canada
facility: Galderma investigational site
Study officials:
affiliation: Windsor Clinical Research Inc.
name: Jerry Tan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.