To evaluate the safety of test products

Phase 1

Completed

• Conditions: Healthy Male and Female subjects

• Registration Number: CTRI/2021/03/032121
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

StudyObjective:

Theobjective of this study is to evaluate the dermatological safety of theinvestigational products on healthy human subjects.

StudyPopulation:

24 healthyhuman volunteers (Male and Female 1:1) with Skin types (Oily, Dry, Normal andCombination, 1:1:1:1 ratio).

Duration ofstudy:

Approximately9 days for each volunteer.

Test Site:

Between thescapula and waist of the subjects, the test site should be free ofpigmentation, pimple, hair, mole or any dermatological condition that caninterfere with the reading.

PatchApplication:

The loadedpatch system is applied at the test site of study subjects starting with thelower edge of the patch system and slowly pressing upwards till the top edge inorder to squeeze out the air.

PatchMethodology:

The patchwill be kept for 24 hours. The patch will be removed after 24 hours. The testsites will be wiped with a clean tissue to remove any residue prior toevaluation. Dermatologist will visually assess the skin condition of each testsite at the following frequencies- 20-30 minutes’ post patch removal (0 hourreading), 24 hrs and 7 days’ post patch removal as per Draize scoring system.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-22
• Study Completion: 2021-03-31
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Subjects in age group 18.
• 65 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 Mukesh Ramnane

Principal investigator

08041125934

mukesh.ramnane@mscr.in