None listed
Conditions
Interventions
Intervention1: Cliantha Code A: Skin care Product (01): Single Application, Approx. 50mg of test products will be applied on subjectâ??s volar forearms, on 3 x 3 cm square test site, as per randomizat
Sponsors
Duosis BioInnovations Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject between ages of 18 to 65 (both inclusive) years old at the time of consent. 2. Gender: Males and non-pregnant, non-lactating females. 3. Female subjects of childbearing potential must have a negative urine pregnancy test performed on Screening visit and Enrolment. 4. Subject general in good health as determined from a recent medical history. 5. Subject is willing to participate in the study, give a voluntary written informed consent. 6. Subjects willing to abide by and comply with the study protocol. 7. Subjects should not participate in any other clinical study during participation in the current study.
Exclusion criteria
Exclusion criteria: 1. Use of Body milk /lotion / cream, cosmetics or any other body moisturizing product before 3-5 days prior to study and during the study period. 2. Chronic illness which may influence the cutaneous state. 3. Subjects on any systemic medication. 4. Subject with history of diabetes. 5. Subjects participating in a similar clinical study, currently or during the previous 30 days. 6. Any subjects, in the Investigator opinion not considered suitable for enrollment. 7. A known history or present condition of allergic response to any other concern that may require medical attention. 8. Subjects with medical history (past/present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g., porphyria) chronic urticaria, or sunburn, rashes. 9. Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos, scars, and sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. volar forearm that can interfere with the reading.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin moisture i.e., hydration state of the skin by Corneometer CM 825 or MoistureMeterSCTimepoint: Baseline i.e., Day 1 before application, T1 hour (plus 15mins), T4 hours (plus 15mins), T8 hours (plus 15mins) after application on Day 1 and T24 hours (plus 15mins) after application on Day 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Product response index (perception about product)Timepoint: T24 hours (plus 15mins) after application on Day 2;Skin physical parameter by Dermatologist | Dermatologist Validated Scorer using 5-point scoring scale for skin dryness, skin roughness, skin redness/erythema, burning, itching and stinging and 8-point scoring scale for skin suppleness and softnessTimepoint: Baseline i.e., Day 1 before application, T1 hour (plus 15mins), T4 hours (plus 15mins), T8 hours (plus 15mins) after application on Day 1 and T24 hours (plus 15mins) after application on Day 2. | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed