Skin Safety Study on Healthy Human Subjects

Completed

• Conditions: Healthy human with Sensitive Skin

• Registration Number: CTRI/2017/08/009257
• Lead Sponsor: Dabur India Ltd

Brief Summary

Study was designed to test the safety of topical products provided by Dabur India Limited on healthy human subjects. 24 subjects were enrolled in the study, out of which all 24 subjects completed the study. Study was conducted over a period of 9 days for each subject. Products were evaluated through single application closed patch test under occlusion for 24 hrs. After patch removal, skin was observed for irritation reactions at 0 hr, 24 hrs post patch removal for immediate reactions and 7 days post patch removal for delayed reactions. As per Draize scale for scoring irritation, all the investigational products emerged as non irritant products when observed at Ohr, 24 hours and 7 days post patch removal All the test products were deemed to be dermatologically safe as per their classification into non­ irritant category at all time points of evaluation by 24 hrs occlusive patch test method (reference BIS 4011:1997).Positive control was confirmed as irritant when observed at Ohr & 24hrs and was confirmed as mild irritant when observed at 7 days post patch removaL

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-15
• Study Completion: 2014-05-28
• Last Update Posted: 2019-11-02

Recruitment & Eligibility

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

Inclusion Criteria

• 1 Subjects in age group 18 -55 years 2 Healthy male and 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 9 Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-I and by dermatological evaluation for the confirmation of the same.

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 •Subjects participating in any other cosmetic or therapeutic study.
• •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 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type	Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type

Secondary Outcome Measures

Name	Time	Method
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type	9 days

Trial Locations

Locations (1)

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

MS Clinical Research Pvt. Ltd.

🇮🇳Bangalore, KARNATAKA, India

Dr Mukesh Ramnane

Principal investigator

8040917253

mukesh.ramnane@mscr.in