Primary irritation Patch test on healthy human volunteers under occlusion for 24hrs

Completed

• Conditions: Skin Sensitivity Test

• Registration Number: CTRI/2016/07/007072
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

Objective:

The objective of this study is to evaluate the dermatological safety of the given investigational products on healthy human volunteers of varied skin types.

Subject 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

The patch will be applied at the test site of study subjects starting with the lower edge of the patch system and slowly pressing upwards till the top edge in order to squeeze out the air.

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: 2015-04-29
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

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

Inclusion Criteria

• •Subjects in the age group 18.
• 55 years (both the ages inclusive). •Healthy male & female subjects. •Subjects with Fitzpatrick 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 having not participated in a similar investigation in the past two weeks. •Subjects willing to come for regular follow up visits. •Subjects ready to follow instructions during the study period.

Exclusion Criteria

• •Infection, allergy on the tested area.
• •Skin allergy, antecedents or atopic subjects.
• •Athletes and subjects with history of excessive sweating.
• •Cutaneous disease which may influence the study result.
• •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 investigational products on healthy human subjects.	Time points 0hr, 24hr and 7days post patch removal

Trial Locations

Locations (1)

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

MS Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr SapnaR

Principal investigator

918040917253

sapna.r@mscr.in