Skin Safety Study on Healthy Human Subjects

Phase 2/3

Completed

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 under occlusion for 24 hrs. The skin was evaluated for signs of irritation identified under Erythema and odema, using Draizeâ€™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 nonÂ irritant category at all time points of evaluation by 24 hrs occlusive patch test method (reference BIS 4011:1997).3% 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

Recruitment & Eligibility

Inclusion Criteria

1 Subjects in age group 18- 55 years 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 Hyper sensitivity to any component of the tested products 4 Athletes and subjects with history of excessive sweating 5 Cutaneous disease which may influence the study result 6 Chronic illness which may influence the cutaneous state.
7 Subjects on oral corticosteroid 8 Subjects participating in any other cosmetic or therapeutic study.
9 Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Primary Outcome Measures

Name	Time	Method
Evaluation of dermatological safety of investigational products by 24 hours patch test under complete occlusion on healthy human subjects.	0 hr, 24 hr, 7 days

Secondary Outcome Measures

Name	Time	Method
Overall safety of Subjects	0 hr, 24 hr, 7 days

Locations (1): MS Clinical Research Pvt. Ltd,
🇮🇳
Bangalore, KARNATAKA, India
MS Clinical Research Pvt. Ltd,
🇮🇳Bangalore, KARNATAKA, India
Dr Sapna R
Principal investigator
8040917253
sapna.r@mscr.in