Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris

Phase 3

Completed

• Conditions: Severe Acne Vulgaris
• Interventions: Drug: Adapalene BPO Gel associated with Doxycyline Hyclate; Drug: Vehicle Gel associated with Doxycycline Hyclate

• Registration Number: NCT00688064
• Lead Sponsor: Galderma R&D

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% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

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)

Study Timeline

• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-02
• Study Start: 2008-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2010-02-23
• Status Verified: 2010-03
• Results First Submitted QC: 2010-03-18
• Results First Posted: 2010-03-31
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

• 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 Criteria

• Subjects with more than 3 nodules or cysts on the face,
• Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Adapalene BPO Gel associated with Doxycyline Hyclate	Adapalene-BPO + Doxycyline
2	Vehicle Gel associated with Doxycycline Hyclate	Vehicle + Doxycycline

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Lesion Counts at Week 12.	Week 12

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.	Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12	Week 12
Success Rate on the Investigator's Global Assessment	Week 12	Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12
Percent of Subjects With Adverse Events	Up to 12 weeks	Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)

Trial Locations

Locations (1)

Galderma Investigational Site; 🇵🇷 Carolina, Puerto Rico