Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Atopic Dermatitis

This study has been completed.
Information provided by (Responsible Party):
Taro Pharmaceuticals USA Identifier:
First received: January 28, 2009
Last updated: January 19, 2014
Last verified: January 2014

The primary objectives are to establish the therapeutic equivalence of tacrolimus ointment 0.1%, manufactured by Taro Pharmaceuticals Inc. and Protopic® (tacrolimus), 0.1% topical ointment (Astellas Pharma US, Inc.) and to show superiority over vehicle in the treatment of moderate to severe atopic dermatitis.

The secondary objectives are to compare the adverse event (AE) profiles of the two ointments and to investigate their systemic absorption at steady state.

Condition Intervention Phase
Atopic Dermatitis
Drug: Tacrolimus 0.1% manufactured by Taro
Drug: Protopic - Tacrolimus 0.1%
Drug: Tacrolimus Vehicle manufactured by Taro
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Clinical Study to Evaluate the Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Moderate to Severe Atopic Dermatitis

Resource links provided by NLM:

Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • ISGA score 0 or 1 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % change in BSA [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • % change in EASI [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • % change in ISGA [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Safety and adverse event profile [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus 0.1% Taro
Tacrolimus 0.1% manufactured by Taro applied for 14 days
Drug: Tacrolimus 0.1% manufactured by Taro
Treatment applied as a thin layer to target area twice daily for 14 days
Active Comparator: Protopic - Tacrolimus 0.1%
Protopic, Tacrolimus 0.1% applied for 14 days
Drug: Protopic - Tacrolimus 0.1%
Treatment applied as a thin layer to target area twice daily for 14 days
Placebo Comparator: Vehicle
Tacrolimus vehicle applied for 14 days
Drug: Tacrolimus Vehicle manufactured by Taro
Treatment applied as a thin layer to target area twice daily for 14 days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or non-pregnant, non-lactating female, 18 years of age or older.
  • Patient has documented evidence that they have been unresponsive to alternative more traditional therapies such as topical corticosteroids, or in the investigators opinion, such first line therapy would be deemed inadvisable because of potential risks to the patient.
  • If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
  • Have confirmed diagnosis of atopic dermatitis using the diagnostic features as described by Hanifin and Rajka.
  • Have an IGSA score of 3 (moderate) or 4 (severe)
  • Have an affected Body Surface Area (BSA) of at least 20%
  • Have a minimum Eczema Area and Severity Index (EASI) score of at least 15

Exclusion Criteria:

  • Mild atopic dermatitis as defined by IGSA score of 0 (clear), 1 (almost clear), or 2 (mild) OR %BSA affected less than 20% OR EASI Score of less than 15.
  • Clinically infected atopic dermatitis at the baseline visit. Tacrolimus is not indicated for the treatment of clinically infected atopic dermatitis
  • Any dermatological condition other than atopic dermatitis that in the Investigator's opinion may interfere with the evaluation of the patient's atopic dermatitis
  • Females who are pregnant, lactating or likely to become pregnant during the study.
  • History of allergy or sensitivity to tacrolimus, pimecrolimus, any macrolides such as clindamycin erythromycin
  • Current diagnosis or history or any disease, which in the Investigators opinion would contraindicate the use of immunosuppressants, including but not limited to human immunodeficiency virus (HIV) and cancer.
  • Use of any nonsteroidal immunosuppressants
  • Regular use of intranasal or inhaled corticosteroids, greater than the equivalent of 2 mg of prednisone/day, within 14 days of the first dosing day.
  • Use of non-sedating histamines are not allowed for at least 7 days prior to the first dosing day or throughout the study.
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  More Information

Responsible Party: Taro Pharmaceuticals USA Identifier: NCT00833079     History of Changes
Other Study ID Numbers: TACR-0707 
Study First Received: January 28, 2009
Last Updated: January 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Taro Pharmaceuticals USA:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Calcineurin Inhibitors
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 22, 2016