Dermatological Safety Study on Healthy Human Subjects with sensitive Skin

Phase 2/3

Completed

• Conditions: Sensitive Skin

• Registration Number: CTRI/2016/12/007514
• Lead Sponsor: Dabur India Limited

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, and all the subjects completed the study. The study was conducted over a period of approximately 9 days for each subject. 40 micro litre of the test product was patched on the back of the subject perceived to have sensitive skin , under occlusion for 24 hrs. The skin was evaluated for signs of irritation identified under Erythema and odema, using Draize’s scale. 

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). SLS was used as positive control in the study 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: 2014-06-25
• Last Update Posted: 2019-11-02

Recruitment & Eligibility

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

Inclusion Criteria

• •Subjects in age group 18 -55 years •Healthy male & female subjects •Subjects with Fitzpatrick skin type IIIto 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.
• •Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-Iand by dermatological evaluation for the confirmation of the same.

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 •Chronic illness which may influence the cutaneous state.
• •Subjects on oral corticosteroid more than 10 mg/day •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	O hr, 24 hr, 7 days

Secondary Outcome Measures

Name	Time	Method
Over all safety of the subjects	0 hr, 24 hr, 7 days

Trial Locations

Locations (1)

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

MS Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Sapna R

Principal investigator

918040917253

sapna.r@mscr.in