A study to evaluate effectiveness of Tacrolimus 0.1% Topical Ointment in the patients of the allergic dermatitis.

Phase 3

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

• Registration Number: CTRI/2012/05/002636
• Lead Sponsor: Accord Healthcare Ltd

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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 650

Inclusion Criteria

1.Male or non-pregnant, non-lactating female of any ethnic group, 18 â?? 70 years of age (both inclusive) at the time of signing the informed consent.

2.Patients having atopic dermatitis according to Hanifin and Rajka diagnostic criteria (Appendix I).

3.Patients with a grading of moderate to severe AD (i.e. a score of at least 4.5) as defined by the scoring system of Rajka and Langeland (Appendix II).

4.Non-immunocompromised adults who have failed to respond adequately to other topical prescription treatments for AD, or when those treatments are not advisable in the opinion of the Investigator.

5.Last application of medicated topical agents, intake of systemic antihistamines, intranasal or inhaled corticosteroids ( > 1 mg/day) should be minimum 7 days prior to randomization.

6.Last application of tacrolimus ointment, intake of systemic corticosteroids and nonsteroidal immunosuppressants should be minimum 3 weeks prior to randomization.

Exclusion Criteria

1.Newly diagnosed or Treatment naïve patients

2.Patients with mild (Rajka and Langeland score of < 4.5) or very severe atopic dermatitis that requires systemic therapy

1.Patients in need of undergoing UV treatments for AD.

2.Clinically infected atopic dermatitis at the baseline visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified