None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy babies with dry skin and/or normal skin determined clinically. 2. Between 3 months and 24 months of age. 3. Parents accepting not to use products with the same end benefit on babies during the entire study duration. 4. Parents cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 5. Parents having signed a Consent Form after being informed orally and in writing of all information concerning the study procedures and study objectives.
Exclusion criteria
Exclusion criteria: 1. Skin allergy antecedents or atopic subject. 2. Hypersensitivity to any cosmetic product, raw material. 3. Any clinically significant systemic or cutaneous disease, which may interfere with study procedures. 4. Babies on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Skin Hydration using MoistureMeter SC after product application. Timepoint: 12 hour | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Skin Hydration using MoistureMeter SC at 24 hours after product application 2.TEWL measurements using VapoMeter at 12 hours and 24 hours after product application. 3. Clinical evaluation for skin tolerance (erythema and oedema), using Draize scale after product applicationTimepoint: 12 hour, 24 hour | — |
Countries
India
Contacts
Sun Pharmaceuticals Industries Ltd