Safety and Efficacy of Body Lotion and Body Wash in Adult Female Subjects with Mild To Moderate Eczema.

Not Applicable

Completed

• Conditions: Health Condition 1: L208- Other atopic dermatitis

• Registration Number: CTRI/2021/03/032149
• Lead Sponsor: Wipro Manufacturing Services Sdn Bhd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

1. Age: 18 to 65 years (both inclusive) old healthy, non-pregnant, and non-lactating female at the time of consent.

2. Females who have childbearing potential should have a negative urine pregnancy test at the time of the screening visit.

3. Mild to Moderate Eczema determined by Eczema Area and Severity Index (EASI) score on screening visit. [Subjects with moderate erythema (Redness: score 2) and mild scratch mark (Scratching: score 1) will be enrolled in the study].

4. Subjects with at least two active lesions on feet/face/hands or any part of the body.

5. Subjects have only a few or no pigmentation on the selected test site.

6. The subjectââ?¬•s in general good health as determined by Investigator based on medical history.

7. Subjects must agree to refrain from shower/bath or generally wet their skin within 3 hours before scheduled study visits.

8. Subjects must agree to wear loose clothing to allow easy exposure to the entire body during study visits.

9. Subjects must be able to understand and provide written informed consent to participate in the study.

10. Subjects should be willing and able to follow the study protocol to participate in the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Selection of unaffected and affected test sites by the dermatologist using instrument evaluations. <br/ ><br>2.Calculation of eczema area by dermatologist using Eczema Area and Severity Index (EASI). <br/ ><br>Timepoint: 1.On Day 01 before application and on Day 14 and Day 28 after product usage <br/ ><br>2.On Day 01 before application and Day 14 and Day 28 after product usage <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.cutaneous tolerance/ local irritation i.e. Erythema, Oedema, Dryness, Flaking, Scaling, Itching, Peeling, Pigmentation for body wash and body lotion <br/ ><br>2.Global Assessment Scale (IGA) for body wash and body lotion <br/ ><br>3.itchiness of skin using Itch NRS scale for body lotion <br/ ><br>4.subjective self-assessment i.e. perceived symptoms of irritation such as Burning, Itching, and Stinging for body wash and body lotion <br/ ><br>5.subjective perception about product for body wash and body lotion <br/ ><br>Timepoint: 1.On Day 01, Day 14 and Day 28 <br/ ><br>2.On Day 01, Day 14 and Day 28 <br/ ><br>3.Day 01 i.e. Baseline, 0 sec before application, to 10 sec, 20 sec, 30 sec, 40 sec, 50 sec, 60 sec, 2 min, 5 min, 10 min and 15 min after application on Day 01. <br/ ><br> <br/ ><br>4.On Day 01, Day 14 and Day 28 <br/ ><br>5.On Day 14 and Day 28 <br/ ><br>