Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: AD-X: Approx. 1 - 2 gm (1-2 fingertip units) of test product to be applied on the face, body and affected area. Product to be used twice daily (morning & evening).
Intervention2: AD-Y:
Sponsors
AVT Natural Products Ltd.
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of severity of atopic dermatitis using Investigator global assessment (IGA). 2. Assessment of eczema using Eczema Area and Severity Index (EASI). 3. Assessment of skin’s itchiness using Itch NRS. 4. Assessment of Skin Moisturization using Corneometer / MoistureMeterSC 5. Assessment of skin barrier function by measuring TEWL using TEWAmeter / Vapometer Timepoint: Day 01 (before application & after application), Day 15, Day 30, Day 45 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Desquamation using 5-point ordinal scaleTimepoint: Day 01 (before application & after application), Day 15, Day 30, Day 45 and Day 60;Assessment of Lichenification using 4-point grading scaleTimepoint: Day 01 (before application & after application), Day 15, Day 30, Day 45 and Day 60;Assessment of Primary Lesions by Punch Biopsy and Histopathologic diagnosisTimepoint: Day 01 (before application & after application), Day 30 and Day 60;Assessment of Product Response Index (Perception about Product) after product usageTimepoint: Day 15, Day 30, Day 45 and Day 60;Assessment of skin erythema / redness using 5-point grading scaleTimepoint: Day 01 (before application & after application), Day 15, Day 30, Day 45 and Day 60;Assessment of skin sebum level using SebumeterTimepoint: Day 01 (before application & after application), Day 15, Day 30, Day 45 and Day 60;Assessment of skin thickness by UltrasonographyTimepoint: Day 01 (before application & after application), Day 30 and Day 60;Assessment of Subject Satisfaction Questionnaire after product usageTimepoint: Day 15, Day 30, Day 45 and Day 60 | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed