None listed
Conditions
Interventions
Intervention1: Excela Lite Daily Skin Nourishing Lotion: Marketed By: Cipla Limited
Test Product: Excela Lite Daily Skin Nourishing Lotion
Mode of usage: Apply the required amount of test product afte
Sponsors
Cipla Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 55 years(both inclusive) at the time of consent. 2. Sex: Healthy male and non-pregnant/non-lactating female. 3. Females of childbearing potential must have a self-reported negative urine pregnancy test. 4. Subjects with skin hydration less than 40 percentage at application site though the instrumental assessment and as per the dermatologist ( for dry skin subjects) 5.Subject is in good general health as determined by the Investigator on the basis of medical history. 6.Subjects should be willing and able to follow the study protocol to participate in the study. 7.Subject must be able to understand and provide written informed consent to participate in the study. 8.Subject is willing to refrain from vigorous physical exercise during the study period. 9.Subjects is willing not to use any other marketed product on application site during the study visit.
Exclusion criteria
Exclusion criteria: 1.Subject has any known allergy to test product ingredient. 2.Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc. 3.Participation in any similar clinical trial within the past 90 days. 4.Currently have any allergies or chronic allergies or sensitivities to soaps, shampoos, conditioners, or any other skin care products as well as fragrances. 5.Currently using any topical medications. 6.Consume any alcoholic beverages during the days of the study. 7.Pregnant or lactating females. 8.Self-reported Positive HIV test. 9.History of Hepatitis B or C virus self-reported. 10.Have any other condition or factor that the Investigator believes may affect interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the effectiveness of the test product in terms of change in skin barrier repair using Tewameter TM Hex. 2.To assess the effectiveness of the test product in terms of change in skin hydration using MoisturemeterEpiD/ Corneometer CM 825. 3. To assess the effectiveness of the test product in terms of change in skin texture using MoisturemeterEpiD/ Corneometer CM 825. 4.To assess the effectiveness of the test product in terms of change in skin dryness, redness, smoothness, roughness, itchiness, and scaliness at application site by dermatologist and dermatologist trained evaluator.Timepoint: Baseline before application of the test product to after application at T0 (20 mins), T1 (01 hrs), and T2 (12 hrs) on Day 01, T24 hrs on Day 2, and 28 Days post usage. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the efficacy of the test product in terms of subjective product perception questionnaire using 9-point hedonic scale. 2. To assess the safety of the test product in terms of adverse events reported by subjects or assessed by the InvestigatorTimepoint: Baseline before application of the test product to after application at T0 (20 mins), T1 (01 hrs), and T2 (12 hrs) on Day 01, T24 hrs on Day 2, and 28 Days. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed