A study to evaluate the skin care product (Tejasvi emulsion) on healthy volunteers for rejuvenated, plump & radiant skin makes the skin soft, supple, and nourished

Phase 4

Registration Number: CTRI/2022/08/044898

Lead Sponsor: Mountain Valley Springs India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Healthy subjects (no infectious and evaluative pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up)

Indian Male/Female subjects.

Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar etc)

Between 20 to 65 years of age, with normal skin condition.

Written informed consent signed by the subject in line with applicable regulation of country.

Exclusion Criteria

Having refused to give her consent by not signing the consent form.

Taking part in another study liable to interfere with this study.

Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis).

Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.

Having cutaneous hypersensitivity.

Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted).

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation will include assessment of local adverse events of redness, itching, rashes and burning sensations and any other local side effect and will be categorized non serious (based on severity grades, patterns, and causality) and serious adverse events. There will be two types of assessment, subject self-assessment and dermatological evaluation by study investigator. <br/ ><br>on a clinical examination. <br/ ><br> <br/ ><br>Parameters: <br/ ><br> <br/ ><br>1.Redness <br/ ><br> <br/ ><br>2.Dryness <br/ ><br> <br/ ><br>3.Itching <br/ ><br> <br/ ><br>4.Irritation <br/ ><br> <br/ ><br>5.Burning sensation on skin. <br/ ><br>The evaluation will be performed using the following scale: 0- None, 1- Slight, 2- Moderate and 3-SevereTimepoint: Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application

Secondary Outcome Measures