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

NCT01014689 | Completed Phase 3 Results

• 1 other identifier: RD.03.SPR.29080
• Study Type: interventional
• Target: 378
• Locations: 9 countries
• Sites: 28

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.

Conditions

Acne Vulgaris

Keywords

acne vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline and Week 12

Study Arms (2)

Adapalene 0.1% / BPO 2.5% gel

ACTIVE COMPARATOR

Drug: Adapalene/ BPO gel with Lymecycline capsules

Adapalene 0.1% / BPO 2.5% Vehicle Gel

PLACEBO COMPARATOR

Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules

Interventions

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

Also known as: Adapalene/BPO with Lymecycline

Adapalene 0.1% / BPO 2.5% gel

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

Also known as: Adapalene/BPO vehicle with Lymecycline

Adapalene 0.1% / BPO 2.5% Vehicle Gel

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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),

You may not qualify if:

• 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,

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (28)

Galderma Investigator site

Canberra, Australia

Location

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Kogarah, Australia

Location

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Melbourne, Australia

Location

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Sydney, Australia

Location

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Brussels, Belgium

Location

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Ghent, Belgium

Location

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Leuven, Belgium

Location

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Belo Horizonte, Brazil

Location

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São Paulo, Brazil

Location

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Bordeaux, France

Location

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Cannes, France

Location

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Martigues, France

Location

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Nantes, France

Location

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Pantin, France

Location

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Pierre-Bénite, France

Location

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Cuxhaven, Germany

Location

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Darmstadt, Germany

Location

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Frankfurt, Germany

Location

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Catania, Italy

Location

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Ferrara, Italy

Location

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Mexico City, Mexico

Location

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Monterrey, Mexico

Location

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Tlalnepantla, Mexico

Location

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Zapopan, Mexico

Location

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Lodz, Poland

Location

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Eskilstuna, Sweden

Location

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Farsta, Sweden

Location

Galderma Investigator site

Hägersten, Sweden

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Lymecycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Tetracyclines; Naphthacenes

Results Point of Contact

• Title: Florence Paliargues / CPM
• Organization: Galderma

florence.paliargues@galderma.com

+33492952957

Study Officials

• Florence Paliargues

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: August 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 18, 2021
• Results First Posted: April 5, 2012

Record last verified: 2012-04

Locations

ME (4); FR (6); BE (3); IT (2); DE (3); PL (1); AU (4); SE (3); BR (2)