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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tacrolimus 0.1% manufactured by Taro
Protopic - Tacrolimus 0.1%
Tacrolimus Vehicle manufactured by Taro
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Tacrolimus 0.1% Taro

    Protopic - Tacrolimus 0.1%

    Vehicle

    Arm Description

    Tacrolimus 0.1% manufactured by Taro applied for 14 days

    Protopic, Tacrolimus 0.1% applied for 14 days

    Tacrolimus vehicle applied for 14 days

    Outcomes

    Primary Outcome Measures

    ISGA score 0 or 1

    Secondary Outcome Measures

    % change in BSA
    % change in EASI
    % change in ISGA
    Safety and adverse event profile

    Full Information

    First Posted
    January 28, 2009
    Last Updated
    January 19, 2014
    Sponsor
    Taro Pharmaceuticals USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00833079
    Brief Title
    Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Atopic Dermatitis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    March 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taro Pharmaceuticals USA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis
    Keywords
    Atopic Dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    500 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tacrolimus 0.1% Taro
    Arm Type
    Experimental
    Arm Description
    Tacrolimus 0.1% manufactured by Taro applied for 14 days
    Arm Title
    Protopic - Tacrolimus 0.1%
    Arm Type
    Active Comparator
    Arm Description
    Protopic, Tacrolimus 0.1% applied for 14 days
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    Tacrolimus vehicle applied for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Tacrolimus 0.1% manufactured by Taro
    Intervention Description
    Treatment applied as a thin layer to target area twice daily for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Protopic - Tacrolimus 0.1%
    Intervention Description
    Treatment applied as a thin layer to target area twice daily for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Tacrolimus Vehicle manufactured by Taro
    Intervention Description
    Treatment applied as a thin layer to target area twice daily for 14 days
    Primary Outcome Measure Information:
    Title
    ISGA score 0 or 1
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    % change in BSA
    Time Frame
    14 days
    Title
    % change in EASI
    Time Frame
    14 days
    Title
    % change in ISGA
    Time Frame
    14 days
    Title
    Safety and adverse event profile
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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