Dermatology study in healthy volunteers

Completed

• Conditions: Fasting Condition

• Registration Number: CTRI/2017/02/007875
• Lead Sponsor: ITC Life Sciences and Technology Centre

Brief Summary

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. 10 test product will tested against 01 control with 24 subjects. total study duration is 10 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-21
• Study Completion: 2017-01-19
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 1. Healthy male and female subjects in the age group of 18.
• 55 years (both the ages inclusive). 2. Subjects with Fitzpatrick skin type III to V. 3. Subjects willing to give a voluntary written informed consent. 4. Subjects willing to maintain the patch test in position for 24 hours. 5.Subject having not participated in a similar investigation in the past two weeks. 6. Subjects willing to come for regular follow up visits. 7. Subjects ready to follow instructions during the study period. 8. Subjects without any open wounds, cuts, abrasions, irritation symptoms.

Exclusion Criteria

• • Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application.
• • Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results.
• • Athletes and subjects with history of excessive sweating.
• • Subjects on oral corticosteroid.
• • Subjects participating in any other cosmetic or therapeutic trial.
• • Subjects with 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

Primary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Trial Locations

Locations (1)

SpinoS Life Science and Research Pvt Ltd; 🇮🇳 Coimbatore, TAMIL NADU, India

SpinoS Life Science and Research Pvt Ltd

🇮🇳Coimbatore, TAMIL NADU, India

Dr K Senthil Kumar

Principal investigator

9994689336

senthilkumar.k@spinoslifescience.com