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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety Comparison of Epiduo Gel Associated With Lymecycline 300 mg Capsules Versus Epiduo Vehicle Gel Associated With Lymecycline 300 mg Capsules in the Treatment of Moderate to Severe Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Adapalene/ BPO gel with Lymecycline capsules
* Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Subjects of any race, aged 12 to 35 years inclusive, Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4), 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.), 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) 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) 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, Subjects with known intolerance to lactose,

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adapalene 0.1% / BPO 2.5% gel<br> | Drug: Adapalene/ BPO gel with Lymecycline capsules<br>* Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning<br>* Other names: Adapalene/BPO with Lymecycline;|
| Placebo Comparator: Adapalene 0.1% / BPO 2.5% Vehicle Gel<br> | Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules<br>* Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning<br>* Other names: Adapalene/BPO vehicle with Lymecycline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Total Lesion Count | Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate on the Investigator's Global Assessment (IGA) at 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. | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne vulgaris