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

Atopic Dermatitis Clinical Trial

— OCT-AD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610142
• Other study ID #: TUD-OCT-AD-025
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2008
• Last updated: June 10, 2014
• Start date: December 2007
• Est. completion date: January 2009

Study information

• Verified date: June 2014
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• pimecrolimus 1% cream
twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks
• hydrocortison 1% cream
twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks

Locations

Country	Name	City	State
Germany	Department of Dermatology, Medical Faculty, TU Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Aschoff R, Schmitt J, Knuschke P, Koch E, Bräutigam M, Meurer M. Evaluation of the atrophogenic potential of hydrocortisone 1% cream and pimecrolimus 1% cream in uninvolved forehead skin of patients with atopic dermatitis using optical coherence tomograph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thickness of epidermis		4 weeks	No
Secondary	thickness of dermis		4 weeks	No