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NCT02601703 Clinical Trial

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)

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 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02601703
Other study ID # GLK-1501
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2015
Est. completion date October 2016

Study information
Verified date July 2019
Source Glenmark Pharmaceuticals Ltd. India
Contact n/a
Is FDA regulated No
Health authority
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 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).

Recruitment information / eligibility
Status Completed
Enrollment 1110
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tacrolimus Ointment 0.1%
apply thin layer of ointment to affected area
• Protopic® ointment, 0.1%
apply thin layer of ointment to affected area
• Placebo of Tacrolimus Ointment
apply thin layer of ointment to affected area

Locations
Country Name City State
United States Glenmark Investigational Site 31 Anaheim California
United States Glenmark Investigational Site 60 Baytown Texas
United States Glenmark Investigational Site 23 Bell Gardens California
United States Glenmark Investigational Site 45 Brooksville Florida
United States Glenmark Investigational Site 30 Cerritos California
United States Glenmark Investigational Site 15 Chula Vista California
United States Glenmark Investigational Site 53 Cincinnati Ohio
United States Glenmark Investigational Site 21 Cleveland Ohio
United States Glenmark Investigational Site 43 Coral Gables Florida
United States Glenmark Investigational Site 34 Doral Florida
United States Glenmark Investigational Site 22 Fort Lauderdale Florida
United States Glenmark Investigational Site 3 Hazleton Pennsylvania
United States Glenmark Investigational Site 41 Henderson Nevada
United States Glenmark Investigational Site 35 Hialeah Florida
United States Glenmark Investigational Site 59 Hialeah Gardens Florida
United States Glenmark Investigational Site 9 High Point North Carolina
United States Glenmark Investigational Site 27 Houston Texas
United States Glenmark Investigational Site 39 Houston Texas
United States Glenmark Investigational Site 8 Houston Texas
United States Glenmark Investigational Site 14 La Mesa California
United States Glenmark Investigational Site 24 Lampasas Texas
United States Glenmark Investigational Site 16 Las Vegas Nevada
United States Glenmark Investigational Site 1 Long Beach California
United States Glenmark Investigational Site 52 Macon Georgia
United States Glenmark Investigational Site12 Madisonville Kentucky
United States Glenmark Investigational Site 11 Miami Florida
United States Glenmark Investigational Site 19 Miami Florida
United States Glenmark Investigational Site 33 Miami Florida
United States Glenmark Investigational Site 40 Miami Florida
United States Glenmark Investigational Site 42 Miami Florida
United States Glenmark Investigational Site 50 Miami Florida
United States Glenmark Investigational Site 51 Miami Florida
United States Glenmark Investigational Site 54 Miami Florida
United States Glenmark Investigational Site 56 Miami Florida
United States Glenmark Investigational Site 58 Miami Florida
United States Glenmark Investigational Site7 Miami Florida
United States Glenmark Investigational Site 28 Miami Gardens Florida
United States Glenmark Investigational Site 29 Miami Lakes Florida
United States Glenmark Investigational Site 18 Miramar Florida
United States Glenmark Investigational Site 37 Missouri City Texas
United States Glenmark Investigational Site 6 Nashville Tennessee
United States Glenmark Investigational Site 32 North Miami Beach Florida
United States Glenmark Investigational Site 17 Oceanside California
United States Glenmark Investigational Site 48 Orlando Florida
United States Glenmark Investigational Site 4 Ormond Beach Florida
United States Glenmark Investigational Site 25 Pasadena California
United States Glenmark Investigational Site 47 Pembroke Pines Florida
United States Glenmark Investigational Site 10 Pflugerville Texas
United States Glenmark Investigational Site 2 Saint Joseph Missouri
United States Glenmark Investigational Site 13 San Antonio Texas
United States Glenmark Investigational Site 26 San Antonio Texas
United States Glenmark Investigational Site 55 San Antonio Texas
United States Glenmark Investigational Site 20 San Ramon California
United States Glenmark Investigational Site 44 Santa Ana California
United States Glenmark Investigational Site 38 Sugar Land Texas
United States Glenmark Investigational Site 49 Tempe Arizona
United States Glenmark Investigational Site 36 Toledo Ohio
United States Glenmark Investigational Site 57 West Columbia South Carolina
United States Glenmark Investigational Site 46 Wilmington North Carolina
United States Glenmark Investigational Site 5 Winter Park 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 Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment Day 15
Secondary 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
See also
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