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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)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tacrolimus Ointment 0.1%
Protopic® ointment, 0.1%
Placebo of Tacrolimus Ointment
Sponsored by
Glenmark Pharmaceuticals Ltd. India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Glenmark Investigational Site 49
  • Glenmark Investigational Site 31
  • Glenmark Investigational Site 23
  • Glenmark Investigational Site 30
  • Glenmark Investigational Site 15
  • Glenmark Investigational Site 14
  • Glenmark Investigational Site 1
  • Glenmark Investigational Site 17
  • Glenmark Investigational Site 25
  • Glenmark Investigational Site 20
  • Glenmark Investigational Site 44
  • Glenmark Investigational Site 45
  • Glenmark Investigational Site 43
  • Glenmark Investigational Site 34
  • Glenmark Investigational Site 22
  • Glenmark Investigational Site 59
  • Glenmark Investigational Site 35
  • Glenmark Investigational Site 28
  • Glenmark Investigational Site 29
  • Glenmark Investigational Site 11
  • Glenmark Investigational Site 19
  • Glenmark Investigational Site 33
  • Glenmark Investigational Site 40
  • Glenmark Investigational Site 42
  • Glenmark Investigational Site 50
  • Glenmark Investigational Site 51
  • Glenmark Investigational Site 54
  • Glenmark Investigational Site 56
  • Glenmark Investigational Site 58
  • Glenmark Investigational Site7
  • Glenmark Investigational Site 18
  • Glenmark Investigational Site 32
  • Glenmark Investigational Site 48
  • Glenmark Investigational Site 4
  • Glenmark Investigational Site 47
  • Glenmark Investigational Site 5
  • Glenmark Investigational Site 52
  • Glenmark Investigational Site12
  • Glenmark Investigational Site 2
  • Glenmark Investigational Site 41
  • Glenmark Investigational Site 16
  • Glenmark Investigational Site 9
  • Glenmark Investigational Site 46
  • Glenmark Investigational Site 53
  • Glenmark Investigational Site 21
  • Glenmark Investigational Site 36
  • Glenmark Investigational Site 3
  • Glenmark Investigational Site 57
  • Glenmark Investigational Site 6
  • Glenmark Investigational Site 60
  • Glenmark Investigational Site 27
  • Glenmark Investigational Site 39
  • Glenmark Investigational Site 8
  • Glenmark Investigational Site 24
  • Glenmark Investigational Site 37
  • Glenmark Investigational Site 10
  • Glenmark Investigational Site 13
  • Glenmark Investigational Site 26
  • Glenmark Investigational Site 55
  • Glenmark Investigational Site 38

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Tacrolimus Ointment 0.1%

Protopic® ointment, 0.1%

Placebo of Tacrolimus Ointment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
November 9, 2015
Last Updated
July 30, 2019
Sponsor
Glenmark Pharmaceuticals Ltd. India
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1. Study Identification

Unique Protocol Identification Number
NCT02601703
Brief Title
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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glenmark Pharmaceuticals Ltd. India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus Ointment 0.1%
Arm Type
Experimental
Arm Title
Protopic® ointment, 0.1%
Arm Type
Active Comparator
Arm Title
Placebo of Tacrolimus Ointment
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tacrolimus Ointment 0.1%
Intervention Description
apply thin layer of ointment to affected area
Intervention Type
Drug
Intervention Name(s)
Protopic® ointment, 0.1%
Intervention Description
apply thin layer of ointment to affected area
Intervention Type
Drug
Intervention Name(s)
Placebo of Tacrolimus Ointment
Intervention Description
apply thin layer of ointment to affected area
Primary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
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).
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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. Key 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Nikhil Sawant
Organizational Affiliation
Glenmark Pharmaceuticals Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Glenmark Investigational Site 49
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
Glenmark Investigational Site 31
City
Anaheim
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 23
City
Bell Gardens
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 30
City
Cerritos
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 15
City
Chula Vista
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 14
City
La Mesa
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 1
City
Long Beach
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 17
City
Oceanside
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 25
City
Pasadena
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 20
City
San Ramon
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 44
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 45
City
Brooksville
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 43
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 34
City
Doral
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 22
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 59
City
Hialeah Gardens
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 35
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 28
City
Miami Gardens
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 29
City
Miami Lakes
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 11
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 19
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 33
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 40
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 42
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 50
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 51
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 54
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 56
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 58
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site7
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 18
City
Miramar
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 32
City
North Miami Beach
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 48
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 4
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 47
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 5
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 52
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Glenmark Investigational Site12
City
Madisonville
State/Province
Kentucky
Country
United States
Facility Name
Glenmark Investigational Site 2
City
Saint Joseph
State/Province
Missouri
Country
United States
Facility Name
Glenmark Investigational Site 41
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
Glenmark Investigational Site 16
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Glenmark Investigational Site 9
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Glenmark Investigational Site 46
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Glenmark Investigational Site 53
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Glenmark Investigational Site 21
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Glenmark Investigational Site 36
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Glenmark Investigational Site 3
City
Hazleton
State/Province
Pennsylvania
Country
United States
Facility Name
Glenmark Investigational Site 57
City
West Columbia
State/Province
South Carolina
Country
United States
Facility Name
Glenmark Investigational Site 6
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Glenmark Investigational Site 60
City
Baytown
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 27
City
Houston
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 39
City
Houston
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 8
City
Houston
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 24
City
Lampasas
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 37
City
Missouri City
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 10
City
Pflugerville
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 13
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 26
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 55
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 38
City
Sugar Land
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this 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)

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