Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Participants diagnosed with Mild to Moderate Eczema (score between 2 - 8) based on Atopic Dermatitis Severity Index (ADSI) 2) Participants with itchy skin. 3) Participants with at least one prominent lesion. 4) Participants 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 5) Female participants of childbearing potential must have a negative urine pregnancy test at enrollment visit.
Exclusion criteria
Exclusion criteria: 1) Participants with serious skin conditions like psoriasis, Uraemic pruritus, etc. 2) Presence of any medical condition or disability that could interfere with study. 3) Participants with any clinically significant systemic disease. 4) Participants having known allergy to active ingredient/raw material of the test product. 5) Presence of any cutaneous condition on test site that could interfere with study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Dermatological assessment for severity of eczema 2) Assessment of Skin ItchinessTimepoint: 1) Day 01 i.e., baseline (before product application) to after application on Day 01 [at 30 mins, 04 hours, 06 hours and 08 hours] and Day 28. 2) Day 01 i.e., baseline (before product application) to after application on Day 01 [10 secs, 20 secs, 30 secs, 40 secs, 50 secs, 60 secs, 02 mins, 30 mins, 04 hours, 06 hours and 08 hours] | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrumental Assessment for skin barrier function by measuring Transepidermal Water Loss (TEWL)Timepoint: Day 01 i.e., baseline (before product application) to after application on Day 01 [at 30 mins, 04 hours, 06 hours and 08 hours] and Day 28.;Instrumental Assessment for skin erythema (anti-redness effect)Timepoint: Day 01 i.e., baseline (before product application) to after application on Day 01 [at 30 mins, 04 hours, 06 hours and 08 hours] and Day 28.;Subjective Evaluation QuestionnaireTimepoint: Day 01 i.e., baseline (before product application), 08 hours post product application on Day 01 and Day 28. | — |
Countries
India
Contacts
Cliantha Research