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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

✍ Scribed by C. Queille-Roussel; C. Paul; L. Duteil; M-C. Lefebvre; G. Rapatz; M. Zagula; J-P. Ortonne


Book ID
104459742
Publisher
John Wiley and Sons
Year
2001
Tongue
English
Weight
515 KB
Volume
144
Category
Article
ISSN
0007-0963

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✦ Synopsis


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.