Status:
COMPLETED
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
Lead Sponsor:
Galderma R&D
Conditions:
Acne
Eligibility:
All Genders
12-35 years
Phase:
PHASE3
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
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT01474590
Start Date
November 1 2011
End Date
August 1 2013
Last Update
February 18 2021
Active Locations (25)
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1
Galderma investigational site
Ajax, Canada
2
Galderma investigational site
Barrie, Canada
3
Galderma investigational site
Calgary, Canada
4
Galderma investigational site
Edmonton, Canada