Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: SoC + Cream: SoC will be applied on each affected areas of skin followed by application of test product. Both SoC and test product will be used twice daily (morning & evening) for 28 da
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male OR non-pregnant and non-lactating female subjects with age of 18-55 years (both inclusive at the time of consent). 2) Subjects diagnosed with atopic dermatitis based on Atopic Dermatitis Severity Index (ADSI) score between 2 - 8 (Mild to Moderate Eczema). 3) Subjects with two independent lesions. 4) Subject must be willing and able to apply the test product as directed, comply with study instructions and commit to all subsequent visits for the duration of the study. 5) Subjects having good general health and free of any disease state or physical condition that might impair evaluation which in the Investigators opinion, exposes the participant to an unacceptable risk by study participation. 6) Female subjects of childbearing potential must have a negative urine pregnancy test performed at screening visit. 7) Subjects willing to follow all the acceptable forms of contraception as applicable. 8) Subjects who are willing to participate in the study and give voluntary written informed consent. 9) Subjects who are willing and able to follow the study protocol to participate in the study. 10) Subjects willing to not participate in any other clinical study during participation in the current study.
Exclusion criteria
Exclusion criteria: 1) Female subjects who are pregnant or breastfeeding or planning pregnancy during the study period. 2) Subjects with dry skin and chronic illness. 3) Subjects with psoriasis (psoriatic lesions). 4) Subjects with any clinically significant systemic disease. 5) Subjects having known allergy to active ingredient OR raw material of the test product. 6) Presence of any cutaneous condition on test site that could interfere with study. 7) Subject who has used an Investigational product in any form or participated in any clinical trial within 30 days prior to first application. 8) Any other condition which could warrant exclusion from the study, as per the investigators discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of test product on eczema by Dermatologist.Timepoint: Day 01, Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Product Response Index (Perception about Product)Timepoint: Day 28;Subject Satisfaction QuestionnaireTimepoint: Day 02, Day 14 and Day 28;To assess the effect of test product on skin barrier function by measuring Transepidermal Water Loss (TEWL)Timepoint: Day 01 and Day 02;To assess the effect of test product on Skin MoisturizationTimepoint: Day 01 and Day 02 | — |
Countries
India
Contacts
Public ContactDr Sagar Katare
Dr. Reddy’s Laboratories Limited
Outcome results
None listed