Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris (TEAM)
This study has been completed.
Sponsor:
Galderma
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01014689
First received: November 16, 2009
Last updated: April 17, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Adapalene/ BPO gel with Lymecycline capsules Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Galderma:
Primary Outcome Measures:
- Percent Change From Baseline in Total Lesion Count [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.
Secondary Outcome Measures:
- Success Rate on the Investigator's Global Assessment (IGA) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]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.
| Enrollment: | 378 |
| Study Start Date: | August 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Adapalene 0.1% / BPO 2.5% gel |
Drug: Adapalene/ BPO gel with Lymecycline capsules
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Other Name: Adapalene/BPO with Lymecycline
|
| Placebo Comparator: Adapalene 0.1% / BPO 2.5% Vehicle Gel |
Drug: 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
Other Name: Adapalene/BPO vehicle with Lymecycline
|
Eligibility| Ages Eligible for Study: | 12 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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,
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014689
Locations
| Australia | |
| Galderma Investigator site | |
| Camberra, Australia | |
| Galderma Investigator site | |
| Kogarah, Australia | |
| Galderma Investigator site | |
| Melbourne, Australia | |
| Galderma Investigator site | |
| Sydney, Australia | |
| Belgium | |
| Galderma Investigator site | |
| Bruxelles, Belgium | |
| Galderma Investigator site | |
| Gent, Belgium | |
| Galderma Investigator site | |
| Leuven, Belgium | |
| Brazil | |
| Galderma Investigator site | |
| Belo Horizonte, Brazil | |
| Galderma Investigator site | |
| Sao Paulo, Brazil | |
| France | |
| Galderma Investigator site | |
| Bordeaux, France | |
| Galderma Investigator site | |
| Cannes, France | |
| Galderma Investigator site | |
| Martigues, France | |
| Galderma Investigator site | |
| Nantes, France | |
| Galderma Investigator site | |
| Pantin, France | |
| Galderma Investigator site | |
| Pierre Benite, France | |
| Germany | |
| Galderma Investigator site | |
| Cuxhaven, Germany | |
| Galderma Investigator site | |
| Darmstadt, Germany | |
| Galderma Investigator site | |
| Frankfurt, Germany | |
| Italy | |
| Galderma Investigator site | |
| Catania, Italy | |
| Galderma Investigator site | |
| Ferrara, Italy | |
| Mexico | |
| Galderma Investigator site | |
| Mexico city, Mexico | |
| Galderma Investigator site | |
| Monterrey, Mexico | |
| Galderma Investigator site | |
| Tlalnepantla, Mexico | |
| Galderma Investigator site | |
| Zapopan, Mexico | |
| Poland | |
| Galderma Investigator site | |
| Lodz, Poland | |
| Sweden | |
| Galderma Investigator site | |
| Eskilstuna, Sweden | |
| Galderma Investigator site | |
| Farsta, Sweden | |
| Galderma Investigator site | |
| Hagersten, Sweden | |
Sponsors and Collaborators
Galderma
Investigators
| Study Director: | Florence Paliargues | Galderma |
More Information
No publications provided
| Responsible Party: | Galderma |
| ClinicalTrials.gov Identifier: | NCT01014689 History of Changes |
| Other Study ID Numbers: | RD.03.SPR.29080 |
| Study First Received: | November 16, 2009 |
| Results First Received: | August 12, 2011 |
| Last Updated: | April 17, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council Sweden: Institutional Review Board Sweden: Swedish Research Council Poland: Ethics Committee Poland: Ministry of Health Italy: Ethics Committee Italy: Ministry of Health Brazil: Ethics Committee Brazil: Ministry of Health Mexico: Ethics Committee Mexico: Ministry of Health Germany: Ethics Commission Germany: Ministry of Health |
Keywords provided by Galderma:
|
acne vulgaris |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Lymecycline Adapalene Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013