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

Not Applicable

Active, not recruiting

• Conditions: The objective of this study is to evaluate the Dermatological efficacy of Tejasvi Emulsion on healthy volunteers

• Registration Number: CTRI/2022/08/044898
• Lead Sponsor: Mountain Valley Springs India Pvt Ltd

Brief Summary

It is a single center, prospective study to evaluateefficacy and safety of skin care formulations (TEJASVI EMULSION) in healthyvolunteers. This study will be conducted in compliance with applicable nationalregulations for post marketing requirement of cosmetic products with the aim ofidentifying or quantifying safety hazards relating to an authorized cosmeticproduct and is aligned with various guidelines and recommendations for goodpharmacovigilance practices for cosmetic products.

This study will also be conducted according to theprinciples of the declaration of Helsinki, GCP guidelines, and all applicablenational regulations for cosmetic trials. Subjects will be invited tovoluntarily participate in the study and no study procedure will be conductedon any subject prior to written informed consent for the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-09
• Last Update Posted: 2023-09-02

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 50

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.	Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application
The evaluation will be performed using the following scale: 0- None, 1- Slight, 2- Moderate and 3-Severe	Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application
on a clinical examination.	Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application
2.Dryness	Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application
3.Itching	Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application
Parameters:	Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application
1.Redness	Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application
4.Irritation	Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application
5.Burning sensation on skin.	Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application

Trial Locations

Locations (1)

Qaaf Healthcare International; 🇮🇳 South, DELHI, India

Qaaf Healthcare International

🇮🇳South, DELHI, India

Dr Esha Roy

Principal investigator

9254425442

dresharoy5@gmail.com