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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01014689




Registration number
NCT01014689
Ethics application status
Date submitted
16/11/2009
Date registered
17/11/2009
Date last updated
18/02/2021

Titles & IDs
Public title
Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris
Scientific 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
Secondary ID [1] 0 0
RD.03.SPR.29080
Universal Trial Number (UTN)
Trial acronym
TEAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne Vulgaris 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Adapalene/ BPO gel with Lymecycline capsules
Treatment: Drugs - Adapalene/ BPO vehicle gel with Lymecycline capsules

Active comparator: Adapalene 0.1% / BPO 2.5% gel -

Placebo comparator: Adapalene 0.1% / BPO 2.5% Vehicle Gel -


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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Total Lesion Count
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Success Rate on the Investigator's Global Assessment (IGA) at Week 12
Timepoint [1] 0 0
Baseline and Week 12

Eligibility
Key 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),
Minimum age
12 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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,

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
378
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Galderma Investigator site - Camberra
Recruitment hospital [2] 0 0
Galderma Investigator site - Kogarah
Recruitment hospital [3] 0 0
Galderma Investigator site - Melbourne
Recruitment hospital [4] 0 0
Galderma Investigator site - Sydney
Recruitment postcode(s) [1] 0 0
- Camberra
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Brazil
State/province [4] 0 0
Belo Horizonte
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
France
State/province [6] 0 0
Bordeaux
Country [7] 0 0
France
State/province [7] 0 0
Cannes
Country [8] 0 0
France
State/province [8] 0 0
Martigues
Country [9] 0 0
France
State/province [9] 0 0
Nantes
Country [10] 0 0
France
State/province [10] 0 0
Pantin
Country [11] 0 0
France
State/province [11] 0 0
Pierre Benite
Country [12] 0 0
Germany
State/province [12] 0 0
Cuxhaven
Country [13] 0 0
Germany
State/province [13] 0 0
Darmstadt
Country [14] 0 0
Germany
State/province [14] 0 0
Frankfurt
Country [15] 0 0
Italy
State/province [15] 0 0
Catania
Country [16] 0 0
Italy
State/province [16] 0 0
Ferrara
Country [17] 0 0
Mexico
State/province [17] 0 0
Mexico city
Country [18] 0 0
Mexico
State/province [18] 0 0
Monterrey
Country [19] 0 0
Mexico
State/province [19] 0 0
Tlalnepantla
Country [20] 0 0
Mexico
State/province [20] 0 0
Zapopan
Country [21] 0 0
Poland
State/province [21] 0 0
Lodz
Country [22] 0 0
Sweden
State/province [22] 0 0
Eskilstuna
Country [23] 0 0
Sweden
State/province [23] 0 0
Farsta
Country [24] 0 0
Sweden
State/province [24] 0 0
Hagersten

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galderma R&D
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01014689
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Florence Paliargues
Address 0 0
Galderma R&D
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01014689