Phase 3 Open label clinical study designed to evaluate the dermatological safety on healthy human subjects.

Phase 3

Completed

• Registration Number: CTRI/2020/02/023304
• Lead Sponsor: Almora Botanica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-03-16
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Subjects in age group 18 - 65 years (both the ages inclusive)

2.Healthy male subjects.

3.Subjects with Fitzpatrick skin type III to V.

4.Subjects willing to give a written informed consent.

5.Subjects willing to maintain the patch test in position for 24 hours.

6.Subject having not participated in a similar investigation in the past one month.

7.Subjects willing to come for regular follow up visits.

8.Subjects ready to follow instructions during the study period.

Exclusion Criteria

1.Infection, allergy on the tested area.

2.Skin allergy, antecedents or atopic subjects.

3.Athletes and subjects with history of excessive sweating.

4.Cutaneous disease which may influence the study result.

5.Subjects on oral corticosteroid.

6.Subjects participating in any other cosmetic or therapeutic study.

7.Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified