A study to check comedogenic potential of cosmetic skin care for 4 weeks

Not Applicable

Completed

• Registration Number: CTRI/2023/01/049199
• Lead Sponsor: ITC Life Sciences & Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-02
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 27

Inclusion Criteria

1.Healthy male and female subjects in the age group of 18-55 years (both age inclusive).

2.Subjects with Fitzpatrick skin type III to V.

3.Subjects willing to give a voluntary written informed consent.

4.Subjects who have apparently healthy skin with prominent follicular orifices on the upper back on visual observation by the investigator.

5.Subjects willing to maintain the test patches in designated positions for 24 Hours after application.

6.Subjects 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.

9.Subjects without any open wounds, cuts, abrasions, irritation symptoms on upper back.

10.Female of childbearing potential, who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study, and throughout the study. The effective contraceptive methods: sexually active females of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intravaginal device, intrauterine device (IUD), condom with spermicide.

Exclusion Criteria

1.Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application.

2.Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results.

3.Subject is Pregnant or Lactating.

4.Athletes and subjects with history of excessive sweating.

5.Subjects on oral corticosteroid, antihistamines or using any topical or systemic medicine which might interfere with the study results.

6.Subjects participating in any other cosmetic or therapeutic trial.

7.Subjects with 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
Primary Outcome is to check the comedogenic potential of test products in comparison to positive and negative <br/ ><br>controls applied topically under occlusion using patch on upper back of healthy human subjects with prominent follicular orifices.Timepoint: Primary Outcome will be assessed on Visit 02 (Baseline visit) and on Visit 25 (End of Study Visit).

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of test products by cutaneous intolerance and Adverse event monitoring. <br/ ><br>Timepoint: At Every Subject Visit (visit01 to Visit 25).