To know the safety of Investigational products by assessing the irritation after patch application on healthy human volunteers.

Completed

• Conditions: Healthy human volunteers with varied skin type.

• Registration Number: CTRI/2012/05/002648
• Lead Sponsor: Kaya Skin Clinic

Brief Summary

Itis a primary irritation patch test under dermatological control. A patch testunder occlusion is carried out using IQ Chambers  an inside area of 9X9mm (81mm2)followed by assessment using Draize scale scoring.

24 healthy human volunteers will be enrolled into the study. Study duration is 9 days for each subject.

Therequired quantity of sample (as updated in the Investigational product manual)will be put on chambers prefixed on tape.

This patch will thenbe applied on the test site i.e. between the scapulae and waist of thesubjects.  The patch will be kept for 24hours. After which the patches will be removed and the first observation willbe made at 30 minutes of patch removal (24 hr reading). The further observationswill be at 48 hr and 7th day post patch application.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-04
• Last Update Posted: 2012-12-26

Recruitment & Eligibility

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

Inclusion Criteria

• Subjects age group 18.
• 55 years. Healthy male & female volunteers. Subjects with skin type III to V. Subjects willing to give a written informed consent. Subjects willing to maintain the patch test in position for 24 hours. Subject has not participated in a similar investigation in the past two weeks. Subjects willing to come for regular follow up. Subjects ready to follow instructions during the study period.

Exclusion Criteria

• Infection, allergy on the tested area History of skin allergy antecedents or atopic subjects History of hyper sensitivity to any component of the tested products Athletes and subjects with history of excessive sweating Cutaneous disease which may influence the study result Chronic illness which may influence the cutaneous state.
• Subjects on oral corticosteroid with dose >10mg/day Subjects participating in any other cosmetic or therapeutic trial.
• 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 given investigational product/s on skin of healthy human volunteers by primary irritation patch test	24 hours, 48 hours and 7 days post patch removal.

Trial Locations

Locations (1)

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

MS Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Mukta Sachdev

Principal investigator

9180-40917253

mukta.sachdev@mscr.in