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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)

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)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02601703
Enrollment
1110
Registered
2015-11-10
Start date
2015-08-31
Completion date
2016-10-31
Last updated
2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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).

Interventions

DRUGTacrolimus Ointment 0.1%

apply thin layer of ointment to affected area

DRUGProtopic® ointment, 0.1%

apply thin layer of ointment to affected area

DRUGPlacebo of Tacrolimus Ointment

apply thin layer of ointment to affected area

Sponsors

Glenmark Pharmaceuticals Ltd. India
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatmentDay 15

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026