Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers

Completed

Conditions: Normal Condition

Registration Number: CTRI/2011/12/002246

Lead Sponsor: ITC RD Centre

Brief Summary: **. Objective:**

The objective of this study is to evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers.

Product/s will be evaluated by carrying out patch test under occlusion for 24 hours.

**. Subject Population:**

24 healthy human volunteers (Male and Female 1:1)

Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio).

**Duration of study:**

5 visits (9 days for each volunteers)

**7. Inclusion / Exclusion Criteria:**

**7.1 Inclusion Criteria:**

ï¿½         Subjects age group 18 - 55 years

ï¿½         Healthy male & female volunteers

ï¿½         Subjects with skin type III to V.

ï¿½         Subjects willing to give a written informed consent.

ï¿½         Subjects willing to maintain the patch test in position for 24 hours

ï¿½         Subject has not participated in a similar investigation in the past two weeks.

ï¿½         Subjects willing to come for regular follow up.

ï¿½         Subjects ready to follow instructions during the study period.

**7.2 Exclusion Criteria:**

ï¿½         Infection, allergy on the tested area

ï¿½         Skin allergy antecedents or atopic subjects

ï¿½         Hyper sensitivity to any component of the tested products

ï¿½         Athletes and subjects with history of excessive sweating

ï¿½         Cutaneous disease which may influence the study result

ï¿½         Chronic illness which may influence the cutaneous state.

ï¿½         Subjects on oral corticosteroid with dose >10mg/day

ï¿½         Subjects participating in any other cosmetic or therapeutic trial.

ï¿½         Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 24

Inclusion Criteria

ï¿½ Subjects age group 18.
55 years ï¿½ Healthy male & female volunteers ï¿½ Subjects with skin type III to V. ï¿½ Subjects willing to give a written informed consent. ï¿½ Subjects willing to maintain the patch test in position for 24 hours ï¿½ Subject has not participated in a similar investigation in the past two weeks. ï¿½ Subjects willing to come for regular follow up. ï¿½ Subjects ready to follow instructions during the study period.

Exclusion Criteria

ï¿½ Infection, allergy on the tested area ï¿½ Skin allergy antecedents or atopic subjects ï¿½ Hyper sensitivity to any component of the tested products ï¿½ Athletes and subjects with history of excessive sweating ï¿½ Cutaneous disease which may influence the study result ï¿½ Chronic illness which may influence the cutaneous state.
ï¿½ Subjects on oral corticosteroid with dose 10mg/day ï¿½ Subjects participating in any other cosmetic or therapeutic trial.
ï¿½ 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
The objective of this study is to evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by dermatological visual assessment.	24HRS, 48HRS, 1 WEEK

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1): MS Clinical Research Pvt. Ltd
🇮🇳
Bangalore, KARNATAKA, India
MS Clinical Research Pvt. Ltd
🇮🇳Bangalore, KARNATAKA, India
Dr Mukta Sachdev
Principal investigator
91-40917253
mukta.sachdev@mscr.in