To test the safety of the products by skin sensitivity test on human subjects.

Completed

• Conditions: Healthy Subjects

• Registration Number: CTRI/2018/02/012202
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

Study Objective: The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects.

Study Population: 24 healthy human volunteers (Male and Female 1:1) with Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio).

Duration of study: Approximately 9 days for each volunteer.

Test Site: Between the scapula and waist of the subjects, the test site should be free of pigmentation, pimple, hair, mole or any dermatological condition that can interfere with the reading.

This patch will then be applied on the test site. The patch will be kept for 24 hours. After which the patches will be removed and the first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hrs and 1 week of patch removal.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-08
• Study Completion: 2017-10-08
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

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

Inclusion Criteria

• 1. Subjects in age group 18.
• 55 years (both the ages inclusive). 2) Healthy male & female subjects. 3) Subjects with Fitzpatrick skin type III to V. 4) Subjects willing to give a voluntary 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 two weeks. 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 trial.
• 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

Primary Outcome Measures

Name	Time	Method
To evaluate the dermatological safety of the investigational products on healthy human subjects	Approximately 9 days for each subject

Trial Locations

Locations (1)

MS Clinical Research Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

MS Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Rachana Shilpakar

Principal investigator

08040917253

rachana.shilpakar@mscr.in