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Bioequivalence of Tretinoin Gel 0.05% in Acne
NCT02249767Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2013
- Primary completion
- Jun 2014
- Sponsor
- Spear Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- tretinoin
- Conditions
- acne vulgaris
01
Overview
Phase 3, randomised, double-blind trial of tretinoin in acne vulgaris (3 arms), sponsored by Spear Pharmaceuticals. Primary endpoint: Percent Change in Baseline Acne Lesions at Week 12. Started Nov 2013; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Generic Tretinoin
Tretinoin Gel 0.05% (Generic)
Brand Tretinoin
Brand Tretinoin Gel 0.05%
Placebo Vehicle
Gel Vehicle
03
Who it enrols
Healthy male and female subjects aged 12-40 with mild acne vulgaris (Grade 2), having 20-40 inflammatory and 25-60 non-inflammatory lesions, and no more than 2 nodulocystic lesions.
04
Endpoints
Primary
Percent Change in Baseline Acne Lesions at Week 12
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