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NCT Number: NCT01014689

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma Investigator site, Canberra, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Adapalene/ BPO gel with Lymecycline capsules

Drug

Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning

Other names: Adapalene/BPO with Lymecycline

Adapalene/ BPO vehicle gel with Lymecycline capsules

Drug

Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning

Other names: Adapalene/BPO vehicle with Lymecycline

Primary outcomes

  1. Percent Change From Baseline in Total Lesion Count

    Time frame: Baseline and Week 12

    Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.

Secondary outcomes

  1. Success Rate on the Investigator's Global Assessment (IGA) at Week 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Acronym: TEAM

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 17, 2009
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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