At a glance
ClinicalIndex Comparison Record- ✓Age 2 to 65 years
- ✓Clinical diagnosis of atopic dermatitis per AAD Consensus Conference (2001)
- ✓At least two bilateral symmetric severe AD lesions with m-EASI ≥7, erythema ≥3, and papulation/infiltration ≥3 on each site, differing by ≤2 points between sides
- ✓Willingness and ability to comply with study requirements
- ✕History of immune deficiencies or malignant disease
- ✕Moderate to severe lichenification at target areas (score 2 or 3)
- ✕Active cutaneous bacterial, viral, or fungal infections in target areas
- ✕History of other skin disorders (e.g., Netherton syndrome) that could interfere with evaluations
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory Double-blind, Randomized, Vehicle-controlled, Paired Study to Evaluate the Efficacy and Safety of Concomitant Use of Elidel Cream 1% and Cutivate Cream 0.05% in Patients With Severe Lesions of Atopic Dermatitis (AD)
In Brief
A Phase 4 clinical trial evaluating Combination of pimecrolimus and fluticasone and pimecrolimus for Atopic Dermatitis. Completed, enrolled 90 participants across 3 sites.
Detailed Summary
Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance. The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids.
Study Details
Timeline
Interventions
Pimecrolimus cream twice a day and fluticasone cream once a day
apply daily with fluticasone cream for flares