Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Pimecrolimus; Tacrolimus

Criteria

Inclusion Criteria:

• clinically diagnosed AD

• almost clear to mild AD (local IGA [target lesions face and cubital areas] score of 1-3)

• clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use

• Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas

Exclusion Criteria:

• Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry

• Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry

• Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation