Evaluation of Dermatological safety of the investigational products by applying patch on the upper back of healthy human volunteers

Completed

• Conditions: Healthy male & female volunteers with no Skin Allergy /Infection

• Registration Number: CTRI/2011/11/002113
• Lead Sponsor: ICHIMARU PHARCOS CO Ltd

Brief Summary

Objective:To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test Subject Population: 24 Healthy Human Volunteers (Male and Female). Duration of Study: 5 Visits (9 Days for each volunteer) **Inclusion Criteria:**1.     Subjects age group 18 - 55 years

2.     Healthy male & female volunteers

3.     Subjects with skin type III to V.

4.     Subjects willing to give a written informed consent.

5.     Subjects willing to maintain the patch test in positionfor  24 hours

6.      Subjecthas not participated in a similar investigation in the past two weeks.

7.     Subjects willing to come for regular follow up.

8.     Subjects ready to follow instructions during the studyperiod.

1.     Infection, allergy on the testedarea

2.     History of skin allergyantecedents or atopic subjects

3.     History of hyper sensitivity toany component of the tested products

4.     Athletes and subjects with history of excessive sweating

5.     Cutaneous disease which mayinfluence the study result

6.     Chronic illness whichmay influence the cutaneous state.

7.     Subjects on oral corticosteroid with dose >10mg/day

8.     Subjects participating in anyother cosmetic or therapeutic trial.

Exclusion Criteria:

1.     Infection, allergy on the testedarea

2.     History of skin allergyantecedents or atopic subjects

3.     History of hyper sensitivity toany component of the tested products

4.     Athletes and subjects with history of excessive sweating

5.     Cutaneous disease which mayinfluence the study result

6.     Chronic illness whichmay influence the cutaneous state.

7.     Subjects on oral corticosteroid with dose >10mg/day

8.     Subjects participating in anyother cosmetic or therapeutic trial.

9.     Any history of underlyinguncontrolled medical illness including diabetes, liver disease or history ofalcoholism, HIV or any other serious medical illness.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-11
• Last Update Posted: 2012-12-26

Recruitment & Eligibility

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

Inclusion Criteria

• 1)Subjects with skin type III to V.
• 2)Subjects willing to give a written informed consent.
• 3)Subjects willing to maintain the patch test in position for 24 hours 4)Subject has not participated in a similar investigation in the past two weeks.
• 5)Subjects willing to come for regular follow up.
• 6)Subjects ready to follow instructions during the study period.

Exclusion Criteria

• 1)Infection, allergy on the tested area 2)History of skin allergy antecedents or atopic subjects 3)History of 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 with dose >10mg/day 8)Subjects participating in any other cosmetic or therapeutic trial.
• 9)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
To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test.	To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test on Day 1, Day 2 & Day 7 of post patch application.

Secondary Outcome Measures

Name	Time	Method
To gather safety information prior to a pilot study and/or larger study, in order to improve the latter’s quality and efficiency of the study design.	Dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test on Day 1, Day 2 & Day 7 of post patch application.

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

918040917253

mukta.sachdev@mscr.in