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

NCT00833079 | Completed Phase 1

• 1 other identifier: TACR-0707
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• ISGA score 0 or 1

  14 days

Secondary Outcomes (4)

• % change in BSA

  14 days

• % change in EASI

  14 days

• % change in ISGA

  14 days

• Safety and adverse event profile

  14 days

Study Arms (3)

Tacrolimus 0.1% Taro

EXPERIMENTAL

Tacrolimus 0.1% manufactured by Taro applied for 14 days

Drug: Tacrolimus 0.1% manufactured by Taro

Protopic - Tacrolimus 0.1%

ACTIVE COMPARATOR

Protopic, Tacrolimus 0.1% applied for 14 days

Drug: Protopic - Tacrolimus 0.1%

Vehicle

PLACEBO COMPARATOR

Tacrolimus vehicle applied for 14 days

Drug: Tacrolimus Vehicle manufactured by Taro

Interventions

Tacrolimus 0.1% manufactured by Taro DRUG

Treatment applied as a thin layer to target area twice daily for 14 days

Tacrolimus 0.1% Taro

Protopic - Tacrolimus 0.1% DRUG

Treatment applied as a thin layer to target area twice daily for 14 days

Protopic - Tacrolimus 0.1%

Tacrolimus Vehicle manufactured by Taro DRUG

Treatment applied as a thin layer to target area twice daily for 14 days

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 30, 2009
• Study Start: October 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 22, 2014

Record last verified: 2014-01