To evaluate the Bio equivalence of two Tacrolimus 0.03% topical Ointment formulations in adult patients with moderate to Severe Atopic Dermatitis

Not Applicable

Completed

• Conditions: Health Condition 1: L209- Atopic dermatitis, unspecified

• Registration Number: CTRI/2016/03/006735
• Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-05-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 346

Inclusion Criteria

1.Male or female aged 18 to 70 years of age (both inclusive)

2.Patients with a diagnosis of atopic dermatitis for at least 3 months

3.Patient with affected area of AD involvement at least 20% body surface area (BSA)

4.Patients with disease severity of grading moderate to severe AD (i.e. a score of 3 or 4) as defined by the scoring system IGA of disease severity

5.Patient treated with bland emollient for at least 7 days prior to randomization

6.Both male and female patients of child bearing potential must be practicing adequate contraception and female patients of childbearing potential must not be/likely to be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization

7.Patient is capable of understanding the purposes and risks of the trial and has given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

8.Patient has not taken and agrees not to take any medication or therapy prohibited by the protocol for the entire study period

Exclusion Criteria

1.Newly diagnosed or treatment naive patients

2.Patients with very severe atopic dermatitis requiring systemic therapy for AD

3.Patient with active cutaneous bacterial or viral infection in any treatment area at baseline

4.History of allergy or hypersensitivity to tacrolimus or any other component of the test product or RLD

5.Patient not willing to minimize or avoid natural and artificial sunlight exposure during treatment

6.Patient with confounding skin conditions

7.Patients with diagnosed renal and hepatic failure

8.Positive Urine drug scan at screening visit for drugs likely to cause abuse

9.Simultaneous participation in any other clinical study

10.Clinically significant laboratory test results or any other condition

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish the therapeutic equivalence between tacrolimus ointment 0.03%, manufactured by Intas Pharmaceuticals Ltd., India and Protopic® (tacrolimus), 0.03% topical ointment manufactured by Astellas Pharma US, Inc.Timepoint: At the end of Study

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety profiles of both ointments and to compare their systemic absorption at steady state.Timepoint: At the end of Study