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

Atopic Dermatitis Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896101
• Other study ID #: GLK-1601
• Status: Completed
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2019
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 755
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus Cream, 1%

• Elidel® (pimecrolimus) Cream

• Placebo of Pimecrolimus Cream, 1%

Locations

Country	Name	City	State
United States	Investigational Site 20	Anaheim	California
United States	Investigational Site 1	Arlington Heights	Illinois
United States	Investigational Site 15	Cincinnati	Ohio
United States	Investigational Site 17	Doral	Florida
United States	Investigational Site 27	East Windsor	New Jersey
United States	Investigational Site 13	Fremont	California
United States	Investigational Site 9	Hialeah	Florida
United States	Investigational Site 5	High Point	North Carolina
United States	Investigational Site 4	Hot Springs	Arkansas
United States	Investigational Site 21	Lake Charles	Louisiana
United States	Investigational Site 22	Little Rock	Arkansas
United States	Investigational Site 16	Miami	Florida
United States	Investigational Site 18	Miami	Florida
United States	Investigational Site 19	Miami	Florida
United States	Investigational Site 25	Miami	Florida
United States	Investigational Site 8	Miami	Florida
United States	Investigational Site 6	Nashville	Tennessee
United States	Investigational Site 26	Norco	California
United States	Investigational Site 12	North Miami Beach	Florida
United States	Investigational Site 3	Ormond Beach	Florida
United States	Investigational Site 23	Raleigh	North Carolina
United States	Investigational Site 11	Saint Joseph	Missouri
United States	Investigational Site 2	Silver Spring	Maryland
United States	Investigational Site 7	South Miami	Florida
United States	Investigational Site 10	Tampa	Florida
United States	Investigational Site 24	Tampa	Florida
United States	Investigational Site 14	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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