Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Atopic Dermatitis - Full Text View

Sponsored by:	Taro Pharmaceuticals USA
Information provided by:	Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:	NCT00833079

Purpose

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 III

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study
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

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 ]

Estimated Enrollment:	500
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tacrolimus 0.1% Taro: Experimental 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
Protopic - Tacrolimus 0.1%: Active Comparator 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
Vehicle: Placebo Comparator 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

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833079

Contacts

Contact: Gail Gongas

(412) 363-3300 ext 522

GDGongas@novumprs.com

Locations

United States, Arizona
Paradigm Clinical Inc.	Recruiting
Tuscon, Arizona, United States
Principal Investigator: Fabia A Kwiecinski, MD
Novara Clinical Research	Recruiting
Mesa, Arizona, United States
Principal Investigator: Terry E O'Reilly, MD
United States, California
Northern California Research	Recruiting
Sacramento, California, United States
Principal Investigator: Douglas G Young, MD
Accelovance	Recruiting
San Diego, California, United States
Principal Investigator: Martin Luther Kabongo, MD
St. Joseph's Medical Associates, Inc.	Recruiting
Stockton, California, United States
Principal Investigator: Shaukat Ali Shah, MD
Torrance Clinical Research	Recruiting
Torrance, California, United States
Principal Investigator: Marina Raikhel, MD, FAAFP
Solano Clinical Research	Recruiting
Vallejo, California, United States
Principal Investigator: Serena M Mraz, MD
United States, Colorado
Horizons Clinical Research Center, LLC	Recruiting
Denver, Colorado, United States
Principal Investigator: David J Kerr, MD
United States, Florida
North Florida Dermatology Associates	Recruiting
Jacksonville, Florida, United States
Principal Investigator: Jonathan Kantor, MD
FXM Research Corp.	Recruiting
Miami, Florida, United States
Principal Investigator: Hector Wiltz, MD
Community Research Foundation, Inc.	Recruiting
Miami, Florida, United States
Principal Investigator: Josefa Binker, MD
Dermatology Trial Associates	Recruiting
Kissimmee, Florida, United States
Principal Investigator: James A Solomon, MD
Accelovance	Recruiting
Melbourne, Florida, United States
Principal Investigator: Murray A Kimmel, DO
United States, Indiana
Indiana Clinical Trial Center	Recruiting
Plainfield, Indiana, United States
Principal Investigator: Scott T Guenthner, MD
Dawes Fretzin Clinical Research Group, LLC	Recruiting
Indianapolis, Indiana, United States
Principal Investigator: Kenneth W Dawes, MD
United States, Kentucky
Dermatology Specialists Research	Recruiting
Louisville, Kentucky, United States
Principal Investigator: Joseph F Fowler, Jr., MD
United States, Michigan
Silverton Skin Institute	Recruiting
Grand Blanc, Michigan, United States
Principal Investigator: Kimball W Silverton, DO
United States, Nevada
K. Heine Clinical Trials	Recruiting
Henderson, Nevada, United States
Principal Investigator: Karl G Heine, MD
United States, North Carolina
Piedmont Medical Research Associates	Recruiting
Winston-Salem, North Carolina, United States
Principal Investigator: Debra Chih-Fen Liu, MD
United States, Ohio
Haber Dermatology & Cosmetic Surgery	Recruiting
So. Euclid, Ohio, United States
Principal Investigator: Robert S Haber, MD
Dermatology Research Associates, Inc.	Recruiting
Cincinnati, Ohio, United States
Principal Investigator: Anne W Lucky, MD
United States, Texas
The University of Texas Health Science Center at Houston	Recruiting
Houston, Texas, United States
Principal Investigator: Adelaide A Hebert, MD
Dermatology Associate of San Antonio	Recruiting
San Antonio, Texas, United States
Principal Investigator: Avered D Dotson, MD
United States, Washington
Premier Clinical Research	Recruiting
Spokane, Washington, United States
Principal Investigator: William P Werschler, MD

Sponsors and Collaborators

Taro Pharmaceuticals USA

Investigators

Study Director:

Darin B Brimhall, DO FACP CPI

Novum Pharmaceutical Research Services

More Information

No publications provided

Responsible Party:	Taro Pharmaceuticals USA ( Medical Director )
Study ID Numbers:	TACR-0707
Study First Received:	January 28, 2009
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00833079 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Taro Pharmaceuticals USA:

Atopic Dermatitis

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Immunologic Factors
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate

Skin Diseases, Eczematous
Tacrolimus
Immunosuppressive Agents
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Dermatitis, Atopic
Skin Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Tacrolimus
Immunosuppressive Agents

Pharmacologic Actions
Hypersensitivity
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on May 06, 2009