Primary Irritation Patch Test on Humans with Normal Skin Type

Not yet recruiting

• Conditions: Healthy Human Volunteers with Normal Skin Type

• Registration Number: CTRI/2020/05/025311
• Lead Sponsor: Dabur India Limited

Brief Summary

The participants will be selected from a volunteer panel with normal skin at the study site. Twenty Four (male and female, in equal ratio) adult subjects in the age group of 18 years to 65 years with normal skin types will be selected according to inclusion and exclusion criteria. Assessment of the irritation potential of investigational products in comparison to positive and negative control will be done using Draize’s scale of each product at different time points (0 hr, 24 hrs, 48 hrs and day 7 after patch removal).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-05-18
• Study Start: 2020-05-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 1.Healthy male and female subjects (1:1 ratio) in the age group of 18-65 years (both age inclusive).
• Subjects with normal skin 3.
• Subjects with Fitzpatrick skin type III to V.
• Female subjects with child bearing potential willing to undergo Urine Pregnancy Test.
• Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results.
• Subjects willing to give a voluntary 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 willing to avoid UV exposure (sun or artificial UV) on test site during the course of study.
• Subjects willing to avoid excessive water contact (e.g. swimming) or activity which causes excessive sweating (like exercises, sauna etc.) during the course of study.
• Subjects should have healthy skin on test area.
• Subjects having valid proof of identity and age.

Exclusion Criteria

• Infection, allergy on the tested area.
• Skin allergy antecedents or atopic subjects.
• Subjects with known hypersensitivity to any of the study products or constituents.
• Subjects with any significant skin pathology in the investigational area 5.
• Athletes and subjects with history of excessive sweating.
• Cutaneous disease which may influence the study result.
• Subjects using any topical or systemic treatment that could interfere with the study treatments/assessments within the last 4 weeks prior to participation in the study and during the study.
• Subjects on oral corticosteroid.
• Subjects participating in any other cosmetic or therapeutic study.
• Female subjects who are pregnant or lactating.
• 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
Evaluation of Dermatological Safety of Investigational Products By 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Subjects with Normal skin	0 hr, 24 hr, 48 hr & 7 days

Trial Locations

Locations (1)

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

MS Clinical Reserch Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Mukesh Ramnane

Principal investigator

8040917253

mukesh.ramnane@mscr.in