Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Elidel® (pimecrolimus) Cream; Drug: Pimecrolimus Cream, 1%; Drug: Placebo of Pimecrolimus Cream, 1%

• Registration Number: NCT02896101
• Lead Sponsor: Glenmark Pharmaceuticals Ltd. India

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-12
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 755

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elidel®	Elidel® (pimecrolimus) Cream	Elidel® (Valeant Pharmaceuticals North America LLC) topical application
Pimecrolimus Cream, 1%	Pimecrolimus Cream, 1%	Pimecrolimus Cream, 1 % (Glenmark Pharmaceuticals Ltd) topical application
Placebo	Placebo of Pimecrolimus Cream, 1%	Placebo of Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) topical application

Primary Outcome Measures

Name	Time	Method
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).	Day 15

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (27)

Investigational Site 4; 🇺🇸 Hot Springs, Arkansas, United States

Investigational Site 22; 🇺🇸 Little Rock, Arkansas, United States

Investigational Site 20; 🇺🇸 Anaheim, California, United States

Investigational Site 13; 🇺🇸 Fremont, California, United States

Investigational Site 26; 🇺🇸 Norco, California, United States

Investigational Site 17; 🇺🇸 Doral, Florida, United States

Investigational Site 9; 🇺🇸 Hialeah, Florida, United States

Investigational Site 16; 🇺🇸 Miami, Florida, United States

Investigational Site 18; 🇺🇸 Miami, Florida, United States

Investigational Site 19; 🇺🇸 Miami, Florida, United States

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