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NCT01014689: TEAM
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
Phase 3 trial testing Adapalene/ BPO gel with Lymecycline capsules in Acne Vulgaris in 378 participants. Completed in 1 May 2010.
1 April 2010
Quick facts
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 378 |
| Start date | 1 August 2009 |
| Primary completion | 1 April 2010 |
| Estimated completion | 1 May 2010 |
| Sites | 28 locations across Australia, Belgium, Brazil, France, Germany, Italy, Mexico, Poland |
Drugs / interventions tested
- Adapalene/ BPO gel with Lymecycline capsules — full drug profile →
- Adapalene/ BPO vehicle gel with Lymecycline capsules — full drug profile →
Conditions studied
- Acne Vulgaris — all drugs for Acne Vulgaris →
Sponsor
Galderma R&D — full company profile →
Who can join
Adults 12 to 35, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Topical benzoyl peroxide for acne.
Yang Z, Zhang Y, Lazic Mosler E, Hu J, et al · · 2020 · cited 29× · PMID 32175593 · DOI 10.1002/14651858.cd011154.pub2
Verify or expand the search:
- PubMed search for NCT01014689
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acne Vulgaris
Currently open trials in the same condition.
- NCT07341087 — Skin Inflammation in Perimenopause: A Probiotic Intervention Proof of Concept Trial · NA · recruiting
- NCT07474883 — Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris · EARLY_PHASE1 · recruiting
- NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
- NCT07056673 — Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study · NA · recruiting
- NCT07102186 — Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris · Phase 4 · recruiting
Other Galderma R&D trials
Trials by the same sponsor.
- NCT07047690 — A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis · Phase 2 · recruiting
- NCT07344584 — A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles · NA · not yet recruiting
- NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
- NCT07398989 — A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With Mature, Crepey Skin · Phase 4 · completed
- NCT06988618 — Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01014689 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Galderma R&D
- Last refreshed: 16 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01014689.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing