The new topical ascomycin derivative SDZ ASM 981 does not induce skin atrophy when applied to normal skin for 4 weeks: a randomized, double-blind controlled study

被引:164
作者
Queille-Roussel, C
Paul, C
Duteil, L
Lefebvre, MC
Rapatz, G
Zagula, M
Ortonne, JP
机构
[1] Nice Univ Hosp, Ctr Pharmacol Clin Appl Dermatol, F-06202 Nice 3, France
[2] Nice Univ Hosp, Serv Dermatol, F-06202 Nice 3, France
[3] Novartis Pharma AG, Clin Res & Dev, Basel, Switzerland
[4] Novartis Pharma SA, Rueil Malmaison, France
关键词
randomized controlled study; SDZ ASM 981; skin atrophy; topical anti-inflammatory agents; topical corticosteroids;
D O I
10.1046/j.1365-2133.2001.04076.x
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background SDZ ASM 981 is a selective inhibitor of inflammatory cytokines released from T lymphocytes and mast cells, which has been developed for the treatment of inflammatory skin diseases. Objectives In the present study, the atrophogenic potential of SDZ ASM 981 1% cream in humans was compared with that of medium and highly potent topical steroids, and vehicle. Methods Four different preparations, SDZ ASM 981 1% cream, the corresponding vehicle of SDZ ASM 981 1% cream, betamethasone-17-valerate 0.1% cream and triamcinolone acetonide 0.1% cream, were applied to the volar aspect of the forearms of 16 healthy volunteers, twice daily, 6 days a week, for 4 weeks. Skin thickness was evaluated by ultrasound examination, clinical signs of atrophy by stereomicroscopy, and epidermal thickness was assessed by histology. Results Both topical corticosteroids induced a significant reduction in skin thickness, as compared with SDZ ASM 981 1% cream and vehicle, which were shown to be equivalent. The difference in skin thickness (measured by ultrasound examination) between patients treated with SDZ ASM 981 1% cream and those receiving either of the two topical steroids was significant from day 8 onwards. Histological analysis performed at day 29 showed significant epidermal thinning with topical steroids compared with SDZ ASM 981 1% cream or the vehicle. Conclusion The lack of atrophogenic properties of SDZ ASM 981 1% cream in this short-term study demonstrates its potential as long-term treatment for inflammatory skin diseases, thus overcoming a major drawback: of topical steroids. This may also be important for the treatment of children, and sensitive areas of skin, such as the face and skin-folds.
引用
收藏
页码:507 / 513
页数:7
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