Primary Irritation Patch Test on Humans with Normal Skin Type

Not yet recruiting

Conditions: Healthy Human Volunteers with Normal Skin Type & Sensitive Skin Type

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 Draizeâ€™s scale of each product at different time points (0 hr, 24 hrs and day 7 after patch removal)

Recruitment & Eligibility

Inclusion Criteria

Group 1 Specific: Subjects scoring less than or equal to 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ€™s skin type questionnaire.
Group 2 Specific: Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ€™s skin type questionnaire.
Common to Group 1 & 2: 1.Healthy male and female subjects (1:1 ratio) in the age group of 18-65 years (both age inclusive).
2.Subjects representing with normal, oily, dry and combination skin type in equal ratio.
3.Subjects with normal Fitzpatrick skin type III to V.
4.Female subjects with child bearing potential willing to undergo Urine Pregnancy Test.
5.Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results.
6.Subjects willing to give a voluntary written informed consent.
7.Subjects willing to maintain the patch test in position for 24 hours.
8.Subject having not participated in a similar investigation in the past two weeks.
9.Subjects willing to come for regular follow up visits.
10.Subjects ready to follow instructions during the study period.

Exclusion Criteria

Common to Group 1 & 2: 1.Infection, allergy on the tested area.
2.Skin allergy antecedents or atopic subjects.
3.Subjects with known hypersensitivity to any of the study products or constituents.
4.Subjects with any significant skin pathology in the investigational area 5.Athletes and subjects with history of excessive sweating.
6.Cutaneous disease which may influence the study result.
7.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.
8.Subjects on oral corticosteroid.
9.Subjects participating in any other cosmetic or therapeutic study.
10.Female subjects who are pregnant or lactating.
11.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 Adult Healthy Human Subjects with Normal skin type and sensitive Skin Type	Evaluation of Dermatological Safety of Investigational Products By 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Subjects with Normal skin type and sensitive Skin Type

Secondary Outcome Measures

Name	Time	Method

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