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ACCESS I: Adapalene-BPO + Doxycycline in Severe Acne Vulgaris
NCT00688064Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2008
- Primary completion
- Feb 2009
- Countries
- 3
- Sponsor
- Galderma
- Modality
- Transdermal Patches, Hydrogel Systems, Small Molecules
- Conditions
- acne vulgaris
01
Overview
Phase 3, randomised, double-blind trial of adapalene and benzoyl peroxide + sulfur in acne vulgaris (2 arms), sponsored by Galderma. Primary endpoint: Percent Change From Baseline in Total Lesion Counts at Week 12. Started Aug 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Adapalene-BPO + Doxycyline
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily + Doxycycline Hyclate 100 mg once daily
Vehicle + Doxycycline
Vehicle Gel once daily + Doxycycline Hyclate 100 mg once daily
03
Who it enrols
Patients aged 12-35 with severe facial acne (IGA score 4), having 20+ inflammatory lesions and 30-120 non-inflammatory lesions, excluding those with >3 nodules/cysts or secondary acne.
04
Endpoints
Primary
Percent Change From Baseline in Total Lesion Counts at Week 12
Secondary
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Success Rate on the Investigator's Global Assessment
Percent of Subjects With Adverse Events
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