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1.
Eur J Dermatol ; 17(1): 45-51, 2007.
Article in English | MEDLINE | ID: mdl-17324827

ABSTRACT

Topical retinoids are often recommended for preventing acne recurrence, but there are relatively few well-controlled maintenance studies published. The objective of the present study was to assess the maintenance effect of adapalene gel 0.1% relative to gel vehicle in subjects successfully treated in a previous 12-week adapalene-lymecycline 300 mg combination therapy study. This was a multicentre, investigator-blind, randomised, controlled study in 19 European centres. A total of 136 subjects with moderate to moderately-severe acne vulgaris who showed at least moderate improvement from baseline when treated with either adapalene plus lymecycline or lymecycline plus gel vehicle in a previous 12 week study were included. Subjects were randomised to receive adapalene gel 0.1% or vehicle once-daily for 12 weeks. Efficacy and safety criteria included maintenance rate, percent reduction in lesion counts (total, inflammatory, non inflammatory), global severity assessment, cutaneous tolerability, and adverse events. Adapalene provided better results relative to gel vehicle for all efficacy assessments. The maintenance rate for total lesions was 84.7% vs. 63.5% (P = 0.0049) with adapalene and the vehicle, respectively. Adapalene was safe and well tolerated in this study. This study demonstrates a clinical benefit of continued treatment with adapalene gel 0.1% as a maintenance therapy for acne.


Subject(s)
Acne Vulgaris/drug therapy , Anti-Bacterial Agents/administration & dosage , Dermatologic Agents/administration & dosage , Lymecycline/administration & dosage , Naphthalenes/administration & dosage , Adapalene , Administration, Oral , Adolescent , Adult , Child , Drug Administration Schedule , Female , Humans , Male , Remission Induction , Single-Blind Method
2.
J Am Acad Dermatol ; 49(3 Suppl): S218-26, 2003 Sep.
Article in English | MEDLINE | ID: mdl-12963898

ABSTRACT

This multicenter, randomized, investigator-blinded study compared the efficacy and tolerability of a combination of lymecycline 300 mg/day orally and adapalene topical gel 0.1% (n = 118) to lymecycline 300 mg/day orally plus vehicle gel (n = 124) in patients with moderate to moderately severe acne vulgaris with both inflammatory and noninflammatory lesions. The primary efficacy end point, total lesion count at end point (last observation carried forward), showed a statistically significant difference in favor of the lymecycline plus adapalene group (P =.0011). The mean decrease in total, inflammatory and noninflammatory lesion counts was significantly greater at end point in the lymecycline plus adapalene group than in the lymecycline plus vehicle group (P <.01). In addition, a significant difference for inflammatory and total acne lesions was seen sooner in the adapalene plus lymecycline group. In total, 75.5% of patients in the lymecycline plus adapalene group were markedly improved, almost clear or clear of their lesions at week 12, compared with 51.8% of those in the lymecycline plus vehicle group (P <.001). Local cutaneous tolerance was generally good in both groups, although more patients receiving the lymecycline plus adapalene combination experienced cutaneous reactions than those receiving lymecycline plus vehicle. There are relatively few studies comparing the efficacy of combined oral and topical therapy with either individual therapy alone. This study clearly demonstrates that lymecycline plus adapalene combination treatment resulted in a significantly greater mean decrease in the number of inflammatory, noninflammatory and total lesions than lymecycline plus vehicle and was well tolerated.


Subject(s)
Acne Vulgaris/drug therapy , Lymecycline/therapeutic use , Naphthalenes/therapeutic use , Acne Vulgaris/diagnosis , Adapalene , Administration, Oral , Administration, Topical , Adolescent , Adult , Child , Dose-Response Relationship, Drug , Drug Administration Schedule , Drug Therapy, Combination , Female , Follow-Up Studies , Humans , Male , Probability , Reference Values , Severity of Illness Index , Single-Blind Method , Treatment Outcome
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