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

Br J Dermatol. 2001 Mar;144(3):507-13. doi: 10.1046/j.1365-2133.2001.04076.x.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Anti-Inflammatory Agents / adverse effects
  • Atrophy / chemically induced
  • Atrophy / diagnostic imaging
  • Dermatologic Agents / adverse effects*
  • Double-Blind Method
  • Enzyme Inhibitors / adverse effects*
  • Female
  • Glucocorticoids
  • Humans
  • Male
  • Ointments
  • Skin / diagnostic imaging
  • Skin / pathology*
  • Tacrolimus / adverse effects*
  • Tacrolimus / analogs & derivatives
  • Ultrasonography


  • Anti-Inflammatory Agents
  • Dermatologic Agents
  • Enzyme Inhibitors
  • Glucocorticoids
  • Ointments
  • pimecrolimus
  • Tacrolimus