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

Novartis

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Pimecrolimus cream 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00367393

CASM981CDE20

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

1

Experimental group

Description:

Pimecrolimus cream 1%

Treatment:

Drug: Pimecrolimus cream 1%