To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Tacrolimus Ointment 0.1%; Drug: Protopic® ointment, 0.1%; Drug: Placebo of Tacrolimus Ointment

• Registration Number: NCT02601703
• 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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1110

Inclusion Criteria

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

Key

Exclusion Criteria

1. Active cutaneous bacterial or viral infection in any treatment area at baseline.
2. Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline.
3. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
4. 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.
5. Known allergy or hypersensitivity to tacrolimus or any other component of the Study products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus Ointment 0.1%	Tacrolimus Ointment 0.1%	-
Protopic® ointment, 0.1%	Protopic® ointment, 0.1%	-
Placebo of Tacrolimus Ointment	Placebo of Tacrolimus Ointment	-

Primary Outcome Measures

Name	Time	Method
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment	Day 15

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (60)

Glenmark Investigational Site 49; 🇺🇸 Tempe, Arizona, United States

Glenmark Investigational Site 31; 🇺🇸 Anaheim, California, United States

Glenmark Investigational Site 23; 🇺🇸 Bell Gardens, California, United States

Glenmark Investigational Site 30; 🇺🇸 Cerritos, California, United States

Glenmark Investigational Site 15; 🇺🇸 Chula Vista, California, United States

Glenmark Investigational Site 14; 🇺🇸 La Mesa, California, United States

Glenmark Investigational Site 1; 🇺🇸 Long Beach, California, United States

Glenmark Investigational Site 17; 🇺🇸 Oceanside, California, United States

Glenmark Investigational Site 25; 🇺🇸 Pasadena, California, United States

Glenmark Investigational Site 20; 🇺🇸 San Ramon, California, United States

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