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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

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

NCT ID

NCT00833079

First Posted

January 28, 2009

Last Updated

January 19, 2014

Sponsor

Taro Pharmaceuticals USA

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

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

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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