To evaluate and compare the in vivo safety and efficacy of Skin Care Formulation versus Untreated control in terms of the Skin Moisturization or Hydration, Skin pH, Skin Brightness, Skin elasticity, Transepidermal Water Loss and Skin Glow on healthy human subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Skin Moisturization or Hydration, Skin pH, Skin Brightness, Skin Elasticity, Transepidermal Water Loss and Skin Glow
Study Overview
Brief Summary
OBJECTIVE- The objective of this study will be to evaluate and compare the in-vivosafety and efficacy of Skin Care Formulation versus Untreated control in terms of the Skin Moisturization/Hydration,Skin pH, Skin Brightness, Skin Elasticity, Transepidermal Water Loss and SkinGlow on healthy human subjects The evaluation will be performed using, Subject Self Evaluation (SSE), Dermatological Evaluation for Cosmetic Acceptability, Corneometry, Skin pH metry,Tewametry , Glossymetry, Denolite, Chromametry, Cutometry
POPULATION- 33 Femalesubjects will be selected for the study. Thesubjects selected for this study will be healthy females, aged between 18 and 40 years old, having dry skin type.STUDY DURATION- 72 hoursfollowing the first application of the product.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Indian or Asian female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Subject having dry skin type.
Exclusion Criteria
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give her/his assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Being epileptic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
- •Having cutaneous hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
Outcomes
Primary Outcomes
Skin Moisturization or Hydration, Skin pH, Skin Brightness, Skin Elasticity, Transepidermal Water Loss and Skin Glow
Time Frame: Baseline, 15 minutes, 30 minutes, 24 Hours, 48 Hours and 72 Hours after product application
Secondary Outcomes
No secondary outcomes reported