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

February 22, 2017 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Novartis, Germany
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Pimecrolimus cream 1%
Drug: Pimecrolimus cream 1%
Pimecrolimus cream 1% bid, as needed
Other Names:
  • ASM981

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• 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
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
• Epidermal thickness by optical coherence tomography at selected investigational centers
Time Frame: 48 weeks
48 weeks
Skin thickness by ultrasound at selected investigational centers
Time Frame: 48 weeks
48 weeks
Epidermal thickness by 3mm punch biopsies (optional)
Time Frame: 48 weeks
48 weeks
Skin metabolism by suction blisters.
Time Frame: 48 weeks
48 weeks
Investigator's Global Assessment (IGA)
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis Pharm, Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Reference: Thaci D et al TBD. CORTICOSTEROID-INDUCED SKIN DAMAGE IMPROVED WITH PIMECROLIMUS CREAM 1% TREATMENT: A 1-YEAR STUDY IN ADULTS WITH ATOPIC ECZEMA. European Academy of Dermatology and Venereology - 17th Congress. 2008; www.eadv.org

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 21, 2006

First Submitted That Met QC Criteria

August 21, 2006

First Posted (Estimate)

August 22, 2006

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASM981CDE20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Clinical Trials on Pimecrolimus cream 1%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe