Status:
COMPLETED
Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
Lead Sponsor:
Galderma R&D
Conditions:
Severe Acne Vulgaris
Eligibility:
All Genders
12-35 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Be...
Detailed Description
Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)
Eligibility Criteria
Inclusion
- Male or female Subjects of any race, aged 12 to 35 years inclusive
- Subjects with severe facial acne (global severity score of 4)
- Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
- Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose
Exclusion
- Subjects with more than 3 nodules or cysts on the face,
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT00688064
Start Date
August 1 2008
End Date
February 1 2009
Last Update
February 18 2021
Active Locations (34)
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1
Galderma Investigational Site
Oceanside, California, United States
2
Galderma Investigational Site
San Diego, California, United States
3
Galderma Investigational Site
Denver, Colorado, United States
4
Galderma Investigational Site
Longmont, Colorado, United States