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

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Elidel® (pimecrolimus) Cream; Drug: Pimecrolimus Cream, 1%; Drug: Placebo of Pimecrolimus Cream, 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02896101

GLK-1601

Details and patient eligibility

About

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).

Enrollment: 755 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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755 participants in 3 patient groups, including a placebo group

Pimecrolimus Cream, 1%

Experimental group

Description:

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

Treatment:

Drug: Pimecrolimus Cream, 1%

Elidel®

Active Comparator group

Description:

Elidel® (Valeant Pharmaceuticals North America LLC) topical application

Treatment:

Drug: Elidel® (pimecrolimus) Cream

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo of Pimecrolimus Cream, 1%