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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00367393

Enrollment

Registered

2006-08-22

Start date

2006-03-31

Completion date

2007-12-31

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema

Brief 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.

Interventions

DRUGPimecrolimus cream 1%

Pimecrolimus cream 1% bid, as needed

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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	48 weeks

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026