Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules; Drug: Adapalene/ BPO gel with Lymecycline capsules

• Registration Number: NCT01014689
• Lead Sponsor: Galderma R&D

Brief Summary

Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.

The safety of the two treatment regimens will also be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Results First Submitted: 2011-08-12
• Results First Submitted QC: 2012-03-09
• Status Verified: 2012-04
• Results First Posted: 2012-04-05
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

1. Male or female Subjects of any race, aged 12 to 35 years inclusive,
2. Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4),

Exclusion Criteria

1. Subjects with more than 3 nodules or cysts on the face
2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
3. Subjects with a wash-out period for topical treatment on the face less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1 week), Phototherapy devices for acne and cosmetic procedures (1 week)
4. Subjects with a wash-out period for systemic treatment less than:Acne therapy containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months), Spironolactone / Drospirenone (3 months)
5. Subjects with impaired hepatic (ALT/AST > 3xULN and bilirubin > 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample,
6. Subjects with known intolerance to lactose,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapalene 0.1% / BPO 2.5% Vehicle Gel	Adapalene/ BPO vehicle gel with Lymecycline capsules	-
Adapalene 0.1% / BPO 2.5% gel	Adapalene/ BPO gel with Lymecycline capsules	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Lesion Count	Baseline and Week 12	Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.

Secondary Outcome Measures

Name	Time	Method
Success Rate on the Investigator's Global Assessment (IGA) at Week 12	Baseline and Week 12	Percentage of Subjects "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.

Trial Locations

Locations (1)

Galderma Investigator site; 🇸🇪 Hagersten, Sweden