Clinical trial NCT01014689: Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: acne vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-11-17
Enrollment: 378
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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,

Primary outcomes:
measure: Percent Change From Baseline in Total Lesion Count
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Success Rate on the Investigator's Global Assessment (IGA) at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Camberra
country: Australia
facility: Galderma Investigator site
city: Kogarah
country: Australia
facility: Galderma Investigator site
city: Melbourne
country: Australia
facility: Galderma Investigator site
city: Sydney
country: Australia
facility: Galderma Investigator site
city: Bruxelles
country: Belgium
facility: Galderma Investigator site
city: Gent
country: Belgium
facility: Galderma Investigator site
city: Leuven
country: Belgium
facility: Galderma Investigator site
city: Belo Horizonte
country: Brazil
facility: Galderma Investigator site
city: Sao Paulo
country: Brazil
facility: Galderma Investigator site
city: Bordeaux
country: France
facility: Galderma Investigator site
city: Cannes
country: France
facility: Galderma Investigator site
city: Martigues
country: France
facility: Galderma Investigator site
city: Nantes
country: France
facility: Galderma Investigator site
city: Pantin
country: France
facility: Galderma Investigator site
city: Pierre Benite
country: France
facility: Galderma Investigator site
city: Cuxhaven
country: Germany
facility: Galderma Investigator site
city: Darmstadt
country: Germany
facility: Galderma Investigator site
city: Frankfurt
country: Germany
facility: Galderma Investigator site
city: Catania
country: Italy
facility: Galderma Investigator site
city: Ferrara
country: Italy
facility: Galderma Investigator site
city: Mexico city
country: Mexico
facility: Galderma Investigator site
city: Monterrey
country: Mexico
facility: Galderma Investigator site
city: Tlalnepantla
country: Mexico
facility: Galderma Investigator site
city: Zapopan
country: Mexico
facility: Galderma Investigator site
city: Lodz
country: Poland
facility: Galderma Investigator site
city: Eskilstuna
country: Sweden
facility: Galderma Investigator site
city: Farsta
country: Sweden
facility: Galderma Investigator site
city: Hagersten
country: Sweden
facility: Galderma Investigator site
Study officials:
affiliation: Galderma R&D
name: Florence Paliargues
role: STUDY_DIRECTOR
References: