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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00833079
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : January 22, 2014
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Brief Summary:

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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. ISGA score 0 or 1 [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. % change in BSA [ Time Frame: 14 days ]
  2. % change in EASI [ Time Frame: 14 days ]
  3. % change in ISGA [ Time Frame: 14 days ]
  4. Safety and adverse event profile [ Time Frame: 14 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Responsible Party: Taro Pharmaceuticals USA Identifier: NCT00833079     History of Changes
Other Study ID Numbers: TACR-0707
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Taro Pharmaceuticals USA:
Atopic Dermatitis

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