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