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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pimecrolimus and Epidermal Barrier Function

NCT01132079

Atopic Dermatitis

COMPLETED NA

Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

NCT00121381

Dermatitis, Atopic

COMPLETED PHASE4

Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion

NCT00925730

Atopic Dermatitis

COMPLETED PHASE4

Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis

NCT00351052

Atopic Dermatitis

COMPLETED PHASE3

Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand Dermatitis

NCT00226707

Chronic Hand Dermatitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Pimecrolimus cream 1%

Group Type EXPERIMENTAL

Pimecrolimus cream 1%

Intervention Type DRUG

Pimecrolimus cream 1% bid, as needed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pimecrolimus cream 1%

Pimecrolimus cream 1% bid, as needed

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ASM981

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No