A SINGLE CENTRE PROSPECTIVE STUDY TO EVALUATE THE EFFICACY (HYDRATE ,TONES, BRIGHTNESS AND RADIANCE) OF SOUNDARYA RADIANCE CREAM
Not Applicable
Active, not recruiting
- Conditions
- The objective of the study is to evaluate the dermatological efficacy of Soundarya Radiance Cream in healthy volunteers
- Registration Number
- CTRI/2022/03/041259
- Lead Sponsor
- Mountain Valley Springs India Pvt Ltd
- Brief Summary
It is a single centre, prospective, open label, non-comparative study to evaluate the efficacy of skin care formulation, SOUNDARYA RADIANCE CREAM in healthy volunteers. This study will be conducted in compliance with applicable national regulations for Post Marketing Surveillance of cosmetic product with the aim of identifying or quantifying safety hazards relating to an authorized cosmetic product and is aligned with various guidelines and recommendations for guideline on PMS practices for cosmetic products.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- 1)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) 2)Indian Male/Female subjects.
- 3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar etc) 4)Between 20 to 65 years of age, with normal skin condition.
- 5)Written informed consent signed by the subject in line with applicable regulation of country.
Exclusion Criteria
- 1)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis).
- 2)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
- 3)Having cutaneous hypersensitivity.
- 4)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 The criteria for the assessment of will be described in terms to evaluate specific parameters that hydrate, tones and bring brightness & radiance in skin care formulations (Soundarya Radiance cream) in healthy volunteer Evaluation will be based on: Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application Subject’s self-assessment Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application Dermatological evaluation by medically qualified study investigator Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application
- Secondary Outcome Measures
Name Time Method Safety evaluation by the investigator will be done at the end of the study. 40 days
Trial Locations
- Locations (1)
QAAF HEATHCARE INTERNATIONAL
🇮🇳South, DELHI, India
QAAF HEATHCARE INTERNATIONAL🇮🇳South, DELHI, IndiaDr Esha RoyPrincipal investigator9254425442esharoy86@gmail.com