Dermatological Safety Study on skin of Healthy Human Subjects

Not Applicable

Completed

• Registration Number: CTRI/2021/03/032229
• Lead Sponsor: Vasu Research Centre A division of Vasu Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-02
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Healthy male and female volunteers aged 18 to 65 with no active

dermatological conditions

2. Good general and mental health with, in the opinion of the

investigator or medically qualified designee with no clinically

significant and relevant abnormalities in medical history or upon

physical examination

3. Subjects who have intact skin on the proposed application site;

dorsum (scapular region)

4. Fitzpatrick phototype I to IV skin type

5. Willingness to participate as evidenced by voluntary written

informed consent

Exclusion Criteria

1. Women who are known to be pregnant or who are intending to

become pregnant over the duration of the study

2. Women who are breast-feeding

3. Any history of significant dermatological diseases or conditions or

medical conditions known to alter skin appearance or physiologic

response (e.g. diabetes,) which could, in the opinion of the

Investigator, preclude topical application of the investigational

products and/or interfere with the evaluation of the test site reaction.

4. Presence of open sores, pimples, or cysts at the application site.

5. Active dermatosis (local or disseminated) that might interfere with

the results of the study.

6. Considered immune compromised.

7. History of diseases aggravated or triggered by ultraviolet radiation.

8. Participants with dermatographism.

9. Currently using any medication which in the opinion of the

investigator, may affect the evaluation of the study product, or place

the subject at undue risk.

10. Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal

anti-inflammatory drugs, and corticosteroids up to 2 weeks before

screening visit.

11. Oral or topical treatment with vitamin A acid and/or its derivatives

up to 1 month before the screening visit

12. Intention of being vaccinated during the study period or

vaccination within 3 weeks of the screening visit.

13. Currently receiving allergy injections, or due to receive an

injection within 7 days prior to Visit1, or expects to begin injections

during study participation

14. Previous history of atop, allergic reactions, irritation or intense

discomfort feelings to topical use products, cosmetics, or medication

15. Known or suspected intolerance or hypersensitivity to any of the

study

materials (or closely related compounds) or any of their stated

ingredient including any component of the patches

16. History of sensitization in a previous patch study

17. Participation in another clinical study (including cosmetic studies)

or receipt of an investigational drug within 30days of the screening

visit

18. Recent history (within the last years) of alcohol or other

substance abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trained evaluator assessment of product <br/ ><br>tolerability through visual assessment of <br/ ><br>cutaneous irritation 24 ±2 and 48 ±2 hours, and <br/ ><br>7 days post patch removal on Day 2.Timepoint: Trained evaluator assessment of product <br/ ><br>tolerability through visual assessment of <br/ ><br>cutaneous irritation 24 ±2 and 48 ±2 hours, and <br/ ><br>7 days post patch removal on Day 2.

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of Adverse EventsTimepoint: Day 2, Day 3 & Day 7