A Clinical Study on Treatment of Tacrolimus (0.03% and 0.1%) Topical Ointment Versus Protopic(0.03% and 0.1%)Topical Ointment in multiple hospitals randomly distributed Atopic Dermatitis in Children and Adults patient population in India

Phase 4

Completed

• Conditions: Health Condition 1: null- Atopic Dermatitis

• Registration Number: CTRI/2011/12/002237
• Lead Sponsor: Biocon Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 378

Inclusion Criteria

•Male or female patients aged between 2 -75 years

•Patients diagnosed with atopic dermatitis as per Hanifin and Rajka diagnostic standards

•Patient/parents/guardian is capable of understanding the purposes and risks of the trial and has given written Informed Consent

•Patient has documented evidence that they have been unresponsive to alternative 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.

•Patients with an IGA score of 3 (moderate) or 4 (severe) at the time of screening

•Patients with Eczema Area and Severity Index (EASI) score of at least 15 at the time of screening

•Treatment naive patients and/or patients receiving treatments for atopic dermatitis other than tacrolimus can be included in the study after 3 days of wash out period

•Female patients of child bearing potential, using double barrier method or use a reliable method of contraception during the study

Exclusion Criteria

•Patient has clinically infected atopic dermatitis at baseline

•Patient with known hypersensitivity to macrolides in general, to tacrolimus or any excipients of the ointment

•Any dermatological condition other than atopic dermatitis that in the Investigators opinion may interfere with the evaluation of the patients atopic dermatitis

•Patients using non-sedating anti-histamines 7 days prior to the first dosing day or at any point during the study

•Current diagnosis or history or any disease, which in the Investigators opinion would contraindicate the use of immunosuppressantâ??s, including but not limited to human immunodeficiency virus (HIV) and cancer.

•Females who are pregnant, lactating or likely to become pregnant during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified