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

Acne Vulgaris Clinical Trial

— TEAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014689
• Other study ID #: RD.03.SPR.29080
• Status: Completed
• Phase: Phase 3
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2012
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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,

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene/ BPO gel with Lymecycline capsules
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
• Adapalene/ BPO vehicle gel with Lymecycline capsules
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning

Locations

Country	Name	City	State
Australia	Galderma Investigator site	Camberra
Australia	Galderma Investigator site	Kogarah
Australia	Galderma Investigator site	Melbourne
Australia	Galderma Investigator site	Sydney
Belgium	Galderma Investigator site	Bruxelles
Belgium	Galderma Investigator site	Gent
Belgium	Galderma Investigator site	Leuven
Brazil	Galderma Investigator site	Belo Horizonte
Brazil	Galderma Investigator site	Sao Paulo
France	Galderma Investigator site	Bordeaux
France	Galderma Investigator site	Cannes
France	Galderma Investigator site	Martigues
France	Galderma Investigator site	Nantes
France	Galderma Investigator site	Pantin
France	Galderma Investigator site	Pierre Benite
Germany	Galderma Investigator site	Cuxhaven
Germany	Galderma Investigator site	Darmstadt
Germany	Galderma Investigator site	Frankfurt
Italy	Galderma Investigator site	Catania
Italy	Galderma Investigator site	Ferrara
Mexico	Galderma Investigator site	Mexico city
Mexico	Galderma Investigator site	Monterrey
Mexico	Galderma Investigator site	Tlalnepantla
Mexico	Galderma Investigator site	Zapopan
Poland	Galderma Investigator site	Lodz
Sweden	Galderma Investigator site	Eskilstuna
Sweden	Galderma Investigator site	Farsta
Sweden	Galderma Investigator site	Hagersten

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

Australia,  Belgium,  Brazil,  France,  Germany,  Italy,  Mexico,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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