To compare the efficacy and safety of Herbavate vs. the conventional steroid therapy in the management of hand dermatitis.

Phase 4

Completed

• Conditions: Health Condition 1: null- Hand Dermatitis

• Registration Number: CTRI/2009/091/000212
• Lead Sponsor: Troikaa Pharmaceuticals 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: 60

Inclusion Criteria

1.18 years of age or older;

2.Have mild to moderate hand dermatitis, according to the Investigator Global Assessment (score2-3);

3.Be generally healthy, as determined by brief medical history;

4.Be capable of understanding and signing the consent form.

Exclusion Criteria

1.Have clinically relevant allergic or irritant contact dermatitis and the inability to avoid exposure;

2.Have severe dermatitis according to the Investigator Global Assessment (score 4);

3.Have severe vesiculation or bullae;

4.Have a history of psoriasis, contact urticaria, and/or pustular diseases;

5.Have had therapy with potent topical corticosteroids within one month prior to enrollment;

6.Have used systemic treatment with oral retinoids, corticosteroids, or with PUVA within the 8 week period prior to the beginning of the study;

7.Have a history or current evidence of a chronic or infectious skin disease

8.Are pregnant or lactating, or women not using highly effective contraception;

9.Current participation in any other interventional clinical trial;

10.Patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use) within 4 weeks prior to randomisation; and

11.Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).

Study & Design

• Study Type: Interventional
• Study Design: Not specified