To Evaluate the Moisturization Properties of Test Products in Healthy Adult Human Subjects.

Suspended

Conditions: Male and Female subjects of age of 18 to 65 years old (both are inclusive at the time of consent) will be enrolled in the study.

Brief Summary: The aim of this observational study is determined the effect of moisturizers properties of various skincare products on all skin types in healthy adultsâ€™ subjects. The proposedbenefits are evaluated by the dermatologist/dermatologist trained evaluator andassessment questionnaire at 24 hours after test product application. Theinstrumental evaluation of skin hydration will be done at beforeapplication to 1 hour (+15mins), 4 hours (+15mins), 8 hours (+15mins), and 24hours (+15mins) after application of 4 skin careproducts.

Recruitment & Eligibility

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

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.

Primary Outcome Measures

Name	Time	Method
Skin moisture i.e., hydration state of the skin by Corneometer CM 825 or MoistureMeterSC	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 Outcome Measures

Name	Time	Method
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 softness	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.
Product response index (perception about product)	T24 hours (plus 15mins) after application on Day 2

Locations (1): Cliantha Research
🇮🇳
Ahmadabad, GUJARAT, India
Cliantha Research
🇮🇳Ahmadabad, GUJARAT, India
Dr Parth Joshi
Principal investigator
8000085049
pjoshi@ofacto.com