Comparison of Atrophogenic Effect of Hydrocortison 1% Cream and Pimecrolimus 1% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHz Ultrasound of Uninvolved Skin in Patients With Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: hydrocortison 1% cream; Drug: pimecrolimus 1% cream

• Registration Number: NCT00610142
• Lead Sponsor: Technische Universität Dresden

Brief Summary

to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on unaffected forehead skin

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-02-07
• Primary Completion: 2008-08
• Study Completion: 2009-01
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-10
• Last Update Posted: 2014-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• age 18-60 years
• diagnosis of atopic dermatitis (Hanifin & Rajka Criteria)
• patients with atopic dermatitis not affecting the forehead

Exclusion Criteria

• pregnancy / nursing mothers
• women in reproductive age without adequate contraception
• severe atopic dermatitis (IGA >= 4)
• UV-Therapy in past 4 weeks
• patients receiving any topical treatment on the face in past 6 month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	hydrocortison 1% cream	-
1	pimecrolimus 1% cream	-

Primary Outcome Measures

Name	Time	Method
thickness of epidermis	4 weeks

Secondary Outcome Measures

Name	Time	Method
thickness of dermis	4 weeks

Trial Locations

Locations (1)

Department of Dermatology, Medical Faculty, TU Dresden; 🇩🇪 Dresden, Germany