None listed
Conditions
Interventions
Intervention1: Test Product A (moisturising cream): Dosage Form: Cream
Duration: 7 Days
Route of Administration: Topical
Frequency: Twice A Day
Dose: 0.2 ml/Site
Mode of Usage: Apply on the designate
Sponsors
S H Kelkar and Company Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject is aged between 18 and 55 years (both inclusive) at the time of informed consent. 2. The subject is a non-pregnant, non-lactating healthy adult female. 3. No previous history of adverse skin conditions, and not under any medication likely to interfere with the results. 4. The subject has a self-reported negative urine pregnancy test. 5. The subject is in a good general health as determined from recent medical history. 6. The subject has willingness and ability to adhere to study directions, and agrees not to use any other skin creams, lotions, serums, etc. at the application sites, except for the specified test products, and return for all specified visits. 7. The subject possesses the ability to comprehend and provide written informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1. The subject is currently pregnant or lactating or is planning to become pregnant during the study period. 2. The subject has a history of allergies or specific allergic reactions upon using dermatological or cosmetic products. 3. The subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment. 4. The subject suffers from any active clinically significant disease or any condition that according to the discretion of the investigator warrants exclusion from the study. 5. The subject is taking or has taken a medication which, in the judgement of the Investigator, makes the subject ineligible or places the subject at undue risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the efficacy of the test products in healing of the wounds on skin, in terms of change in skin barrier function. 2. To assess the efficacy of the test products in healing of the wounds on skin, in terms of change in skin hydration. 3. To assess the efficacy of the test products in healing of the wounds on skin, by evaluating the skin surface topography in terms of skin roughness, wrinkles, scaliness, smoothness, and a 3D skin ultrasound. Timepoint: On Day -01, at two time-points on Day 01 (pre-dose and post dose at T12 hours), and subsequently on Days 02, 03, and 07. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the efficacy of the test products in healing of the wounds on skin, in terms of change in skin irritation, dryness, scaling, peeling, itching, swelling, and smoothness.Timepoint: On Day -01, at two time-points on Day 01 (pre-dose and post dose at T12 hours), and subsequently on Days 02, 03, and 07. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed