Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris (TEAM)

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules; Drug: Adapalene/ BPO gel with Lymecycline capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01014689

RD.03.SPR.29080

Details and patient eligibility

About

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.

Enrollment: 378 patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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378 participants in 2 patient groups, including a placebo group

Adapalene 0.1% / BPO 2.5% gel

Active Comparator group

Treatment:

Drug: Adapalene/ BPO gel with Lymecycline capsules

Adapalene 0.1% / BPO 2.5% Vehicle Gel

Placebo Comparator group

Treatment:

Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules