Abstract | BACKGROUND: OBJECTIVES: To evaluate the efficacy and safety of oral lymecycline 300 mg with adapalene 0·1%-BPO 2·5% (A/BPO) fixed-dose gel in comparison with oral lymecycline 300 mg with a vehicle gel in subjects with moderate to severe acne vulgaris. METHODS: A total of 378 subjects were randomized in a double-blind, controlled trial to receive once-daily lymecycline with either A/BPO or vehicle for 12 weeks. Evaluations included percentage changes from baseline in lesion counts, success rate (subjects 'clear' or 'almost clear'), skin tolerability, adverse events and patients' satisfaction. RESULTS: The median percentage reduction from baseline in total lesion counts at week 12 was significantly higher (P < 0·001) in the lymecycline with A/BPO group (-74·1%) than in the lymecycline with vehicle group (-56·8%). The success rate was significantly higher (47·6% vs. 33·7%, P = 0·002) in subjects treated with lymecycline and A/BPO. Both inflammatory and noninflammatory lesions were significantly reduced at week 12 (both P < 0·001) with a rapid onset of action from week 2 for noninflammatory lesions (P < 0·001) and week 4 for inflammatory lesions (P = 0·005). The A/BPO and lymecycline combination was well tolerated. The proportion of satisfied and very satisfied subjects was similar in both groups, but the number in the A/BPO group who were 'very satisfied' was significantly greater (P = 0·031). CONCLUSION: These results demonstrate the clinical benefit of combining A/BPO with lymecycline in the treatment of moderate to severe acne vulgaris.
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Authors | B Dréno, R Kaufmann, S Talarico, V Torres Lozada, M A Rodríguez-Castellanos, M Gómez-Flores, J De Maubeuge, M Berg, P Foley, A Sysa-Jedrzejowska, N Kerrouche, F Paliargues, V Bettoli |
Journal | The British journal of dermatology
(Br J Dermatol)
Vol. 165
Issue 2
Pg. 383-90
(Aug 2011)
ISSN: 1365-2133 [Electronic] England |
PMID | 21495995
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2011 The Authors. BJD © 2011 British Association of Dermatologists 2011. |
Chemical References |
- Anti-Bacterial Agents
- Dermatologic Agents
- Gels
- Naphthalenes
- Pharmaceutical Vehicles
- Adapalene
- Lymecycline
- Benzoyl Peroxide
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Topics |
- Acne Vulgaris
(drug therapy)
- Adapalene
- Administration, Oral
- Administration, Topical
- Adolescent
- Adult
- Anti-Bacterial Agents
(administration & dosage, adverse effects)
- Benzoyl Peroxide
(administration & dosage, adverse effects)
- Child
- Dermatologic Agents
(administration & dosage, adverse effects)
- Double-Blind Method
- Drug Therapy, Combination
(methods)
- Female
- Gels
- Humans
- Lymecycline
(administration & dosage, adverse effects)
- Male
- Naphthalenes
(administration & dosage, adverse effects)
- Patient Satisfaction
- Pharmaceutical Vehicles
- Treatment Outcome
- Young Adult
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