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NCT00367393 Clinical Trial

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

Atopic Dermatitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00367393
Other study ID # CASM981CDE20
Secondary ID
Status Completed
Phase Phase 4
First received August 21, 2006
Last updated February 22, 2017
Start date March 2006
Est. completion date December 2007

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pimecrolimus cream 1%
Pimecrolimus cream 1% bid, as needed

Locations
Country Name City State
Germany Novartis Novartis

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome
Type Measure Description Time frame Safety issue
Primary • 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 48 weeks
Secondary • Epidermal thickness by optical coherence tomography at selected investigational centers 48 weeks
Secondary Skin thickness by ultrasound at selected investigational centers 48 weeks
Secondary Epidermal thickness by 3mm punch biopsies (optional) 48 weeks
Secondary Skin metabolism by suction blisters. 48 weeks
Secondary Investigator's Global Assessment (IGA) 48 weeks
See also
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Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2

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