skin sensitivity occlusive patch test for 24hrs on healthy human volunteers

Completed

• Conditions: Skin Sensitivity test

• Registration Number: CTRI/2018/02/012000
• 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 required quantity of the sample will be put on the upper back of  subjects and closed with IQ 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.

 Results: Investigational products emerged as non irritant products when observed at 0hr, 24 hrs and 7 days post patch removal. Positive control was confirmed as irritant when observed at 0 hr and 24 hrs post patch removal and was non irritant when observed at day 7 post patch removal.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-25
• Study Completion: 2014-10-07
• Last Update Posted: 2018-02-16

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 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 with dose >10mg/day.
• 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 given investigational products on healthy human volunteers of varied skin types.	0hrs,24 hrs and 7 days post patch removal reading volunteers of varied skin types.

Trial Locations

Locations (1)

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

MS Clinical Rsearch Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Sapna r

Principal investigator

918040917253

sapna.r@mscr.in