Skip to main content
OpenTrials
Completed

NCT Number: 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)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Glenmark Investigational Site 49, Tempe, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus Ointment 0.1%

Drug

apply thin layer of ointment to affected area

Protopic® ointment, 0.1%

Drug

apply thin layer of ointment to affected area

Placebo of Tacrolimus Ointment

Drug

apply thin layer of ointment to affected area

Primary outcomes

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

    Time frame: 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).

    Time frame: Day 15

Sponsors and collaborators

Lead sponsor

Glenmark Pharmaceuticals Ltd. India

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 10, 2015
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.