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Completed

NCT Number: NCT00610142

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Dermatology, Medical Faculty, TU Dresden

Dresden, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pimecrolimus 1% cream

Drug

twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks

Other names: Elidel 1% cream

hydrocortison 1% cream

Drug

twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks

Other names: Hydrogalen cream

Primary outcomes

  1. thickness of epidermis

    Time frame: 4 weeks

Secondary outcomes

  1. thickness of dermis

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Acronym: OCT-AD

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Feb 7, 2008
Registry last updated
Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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