A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (Tacrolimus) Ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD)

Glenmark Pharmaceuticals Ltd. India60 sites in 1 country1,110 target enrollmentAugust 2015

ConditionsAtopic Dermatitis

InterventionsTacrolimus Ointment 0.1%Protopic® ointment, 0.1%Placebo of Tacrolimus Ointment

DrugsTacrolimus Ointment 0.1%Protopic® ointment, 0.1%Placebo of Tacrolimus Ointment

Overview

Phase: Phase 3
Intervention: Tacrolimus Ointment 0.1%
Conditions: Atopic Dermatitis
Sponsor: Glenmark Pharmaceuticals Ltd. India
Enrollment: 1110
Locations: 60
Primary Endpoint: Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment
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 Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

October 2016

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

•Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or older with a clinical diagnosis of moderate to severe AD.
•Have confirmed diagnosis of atopic dermatitis for at least 3 months using the diagnostic features as described by Hanifin and Rajka
•Have an IGA score of 3 (moderate) or 4 (severe).
•Have an affected Body Surface Area (BSA) of at least 20% at baseline.
•Treated with a bland emollient for at least 7 days.

Exclusion Criteria

•Active cutaneous bacterial or viral infection in any treatment area at baseline.
•Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline.
•History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
•History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
•Known allergy or hypersensitivity to tacrolimus or any other component of the Study products.

Arms & Interventions

Tacrolimus Ointment 0.1%

Intervention: Tacrolimus Ointment 0.1%

Protopic® ointment, 0.1%

Intervention: Protopic® ointment, 0.1%

Placebo of Tacrolimus Ointment

Intervention: Placebo of Tacrolimus Ointment

Outcomes

Primary Outcomes

Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment

Time Frame: Day 15

Secondary Outcomes

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