24hrs occlusive Primary irritation Patch test on healthy human volunteers

Completed

• Conditions: Skin Sensitivity Test

• Registration Number: CTRI/2018/02/012014
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

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|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.

Results: Investigational products 1-10 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 0hr and 24 hrs post patch removal and was non irritant when observed at day 7 post patch removal. The assessment was done as per Draize scale for scoring irritation mentioned in Clause 4.3.1.3 in IS 4011:1997 Methods of test for safety evaluation of cosmetics, reaffirmed (2004), Edition 3.2 (2007-11), second revision (ICS 71.100.40), clause 4.3.1,4.3.1.2 BIS 2008 at 0 hr, 24 hrs and day 7  post patch removal readings. Slight erythema and oedema is observed in some subjects and was resolved after sometime.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-04
• Study Completion: 2015-04-14
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Subjects in the 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 investigational products on healthy human subjects.	Ohr,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 Rachana Shilpakar

Principal investigator

08041125934

rachana.shilpakar@mscr.in