A study to evaluate the Safety and Efficacy of 1 test product in adult subjects with mild to moderate Atopic Dermatitis

Not Applicable

Completed

• Conditions: Health Condition 1: L209- Atopic dermatitis, unspecified

• Registration Number: CTRI/2023/03/050902
• Lead Sponsor: AVT Natural Products Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-07-19
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

1) Subjects with an Investigators Global Assessment (IGA) score of 2 to 3 at screening and baseline.

2) Subjects with mild to moderate eczema determined by Eczema Area and Severity Index (EASI) score [Subjects with moderate erythema (Redness: score 2) and mild scratch mark (Scratching: score 1)].

3) Subjects with a history of AD for at least 2 years.

Exclusion Criteria

1) Subjects who have used systemic treatments that could affect AD or have taken treatment for AD within 30 days or 5 half- lives. (i.e., retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids or similar medication).

2) Subjects who require any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies).

3) Subjects who have any active infections or has used antibiotics in the past 7 days.

4) Subjects who have any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments (i.e., cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne).

5) Subjects who have an immunologic or infectious disease (e.g., hepatitis, tuberculosis, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results.

6) Subjects who have other skin conditions that might interfere with AD diagnosis and/or evaluation (i.e., psoriasis current active viral, bacterial and fungal skin infections) as assessed by the Investigator.

7) Subjects with chronic illness which may influence the cutaneous state.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Assessment of severity of atopic dermatitis using Investigator global assessment (IGA). <br/ ><br>2. Assessment of eczema using Eczema Area and Severity Index (EASI). <br/ ><br>3. Assessment of skin’s itchiness using Itch NRS. <br/ ><br>4. Assessment of Skin Moisturization using Corneometer / MoistureMeterSC <br/ ><br>5. Assessment of skin barrier function by measuring TEWL using TEWAmeter / Vapometer <br/ ><br>Timepoint: Day 01 (before application & after application), Day 15, Day 30, Day 45 and Day 60