Clinical trial NCT02601703: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
First posted: 2015-11-10
Enrollment: 1110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

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