A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (Pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).

Glenmark Pharmaceuticals Ltd. India27 sites in 1 country755 target enrollmentAugust 2016

ConditionsAtopic Dermatitis

InterventionsPimecrolimus Cream, 1%Elidel® (pimecrolimus) Cream Placebo of Pimecrolimus Cream, 1%

DrugsPimecrolimus Cream, 1%Elidel® (pimecrolimus) Cream Placebo of Pimecrolimus Cream, 1%

Overview

Phase: Phase 3
Intervention: Pimecrolimus Cream, 1%
Conditions: Atopic Dermatitis
Sponsor: Glenmark Pharmaceuticals Ltd. India
Enrollment: 755
Locations: 27
Primary Endpoint: The proportion of subjects in each treatment group with treatment success (i.e., a grade of clear or almost clear; a score of 0 or 1, within the treatment area) based on the IGA of Disease Severity at the end of treatment (Visit 3; Day 15 ± 3).
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

June 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Glenmark Pharmaceuticals Ltd. India

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or non-pregnant, non-lactating female subjects 12 years of age and older.
•Non-immunocompromised, with a clinical diagnosis of mild to moderate AD that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable.
•Confirmed diagnosis of AD for at least 3 months using the diagnostic features as described by Hanifin and Rajka.
•IGA score of 2 (mild) or 3 (moderate) and ≥ 5% BSA affected at baseline.

Exclusion Criteria

•Active cutaneous bacterial, viral or fungal infection in any treatment area at baseline (e.g., clinically infected AD).
•Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline and history or presence of skin conditions that would interfere with evaluations.
•History or presence of Netherton's Syndrome, immunological deficiencies or diseases, organ transplant, HIV, diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant severe renal insufficiency or severe hepatic disorders.
•Use within one month before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) psoralen plus ultraviolet A therapy (PUVA), 4) tanning booths, 5) non-prescription ultraviolet (UV) light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus or 10) pimecrolimus.
•Use within 14 days before baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin D preparations, or 3) retinoids.
•Use within 7 days before baseline of: 1) antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.

Arms & Interventions

Pimecrolimus Cream, 1%

Pimecrolimus Cream, 1 % (Glenmark Pharmaceuticals Ltd) topical application

Intervention: Pimecrolimus Cream, 1%

Elidel®

Elidel® (Valeant Pharmaceuticals North America LLC) topical application

Intervention: Elidel® (pimecrolimus) Cream

Placebo

Placebo of Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) topical application

Intervention: Placebo of Pimecrolimus Cream, 1%

Outcomes

Primary Outcomes

The proportion of subjects in each treatment group with treatment success (i.e., a grade of clear or almost clear; a score of 0 or 1, within the treatment area) based on the IGA of Disease Severity at the end of treatment (Visit 3; Day 15 ± 3).

Time Frame: Day 15

Secondary Outcomes

Change in severity score from baseline to Visit 3 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).(Day 15)