Skip to main content
OpenTrials
Completed

NCT Number: NCT00367393

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema 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 4

Primary location

Novartis

Novartis, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

pimecrolimus cream 1%

Drug

Pimecrolimus cream 1% bid, as needed

Other names: ASM981

Primary outcomes

  1. • Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study

    Time frame: 48 weeks

Secondary outcomes

  1. • Epidermal thickness by optical coherence tomography at selected investigational centers

    Time frame: 48 weeks

  2. Skin thickness by ultrasound at selected investigational centers

    Time frame: 48 weeks

  3. Epidermal thickness by 3mm punch biopsies (optional)

    Time frame: 48 weeks

  4. Skin metabolism by suction blisters.

    Time frame: 48 weeks

  5. Investigator's Global Assessment (IGA)

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An Open-label Multicenter 12-month Long Term Study on Skin Reconstitution With Pimecrolimus Cream 1% in Adult Patients With Atopic Eczema and Corticosteroid Induced Skin Damage

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 22, 2006
Registry last updated
Feb 24, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.