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)
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)
1 other identifier
interventional
1,110
1 country
60
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2015
Shorter than P25 for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJuly 31, 2019
July 1, 2019
1.2 years
November 9, 2015
July 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment
Day 15
Secondary Outcomes (1)
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
Study Arms (3)
Tacrolimus Ointment 0.1%
EXPERIMENTALProtopic® ointment, 0.1%
ACTIVE COMPARATORPlacebo of Tacrolimus Ointment
PLACEBO COMPARATORInterventions
apply thin layer of ointment to affected area
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Glenmark Investigational Site 44
Santa Ana, California, United States
Glenmark Investigational Site 45
Brooksville, Florida, 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 35
Hialeah, Florida, United States
Glenmark Investigational Site 59
Hialeah Gardens, Florida, 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 32
North Miami Beach, Florida, United States
Glenmark Investigational Site 48
Orlando, Florida, United States
Glenmark Investigational Site 4
Ormond Beach, Florida, United States
Glenmark Investigational Site 47
Pembroke Pines, Florida, United States
Glenmark Investigational Site 5
Winter Park, Florida, United States
Glenmark Investigational Site 52
Macon, Georgia, United States
Glenmark Investigational Site12
Madisonville, Kentucky, United States
Glenmark Investigational Site 2
Saint Joseph, Missouri, United States
Glenmark Investigational Site 41
Henderson, Nevada, United States
Glenmark Investigational Site 16
Las Vegas, Nevada, United States
Glenmark Investigational Site 9
High Point, North Carolina, United States
Glenmark Investigational Site 46
Wilmington, North Carolina, United States
Glenmark Investigational Site 53
Cincinnati, Ohio, United States
Glenmark Investigational Site 21
Cleveland, Ohio, United States
Glenmark Investigational Site 36
Toledo, Ohio, United States
Glenmark Investigational Site 3
Hazleton, Pennsylvania, United States
Glenmark Investigational Site 57
West Columbia, South Carolina, United States
Glenmark Investigational Site 6
Nashville, Tennessee, United States
Glenmark Investigational Site 60
Baytown, Texas, 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 24
Lampasas, Texas, United States
Glenmark Investigational Site 37
Missouri City, Texas, United States
Glenmark Investigational Site 10
Pflugerville, Texas, 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 38
Sugar Land, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Nikhil Sawant
Glenmark Pharmaceuticals Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
November 10, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
July 31, 2019
Record last verified: 2019-07