To evaluate whether the test products causes skin sensitivity / irritation after patch application on human volunteers.

Completed

• Conditions: Skin Sensitivity

• Registration Number: CTRI/2013/01/003306
• Lead Sponsor: ITC RD Center

Brief Summary

It is a dermatologically controlled primary irritation patch test. A patch test under occlusion is carried out using IQ Chambers with an inside area of 9X9mm (81mm2).This will be  followed by assessment using Draize scale scoring.

24 Healthy human volunteers (Male and Female subjects) will be enrolled into the study.

Study duration is 9 days for each subject.

Approximately 40 microliters of the test samples will be loaded onto chambers prefixed on tape.

This patch will then be applied on the test site i.e. between the scapulae and waist of the subjects. 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 hr and 1 week of patch removal.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-11
• Last Update Posted: 2013-03-10

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 • Skin allergy antecedents or atopic subjects • 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	0 hour post patch removal, 24 hour and 7 days reading

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

918040917253

mukta.sachdev@mscr.in