A prospective dermatological study of Soundarya Night Elixir formulation to evaluate age defying parameters in healthy human participants.
Not Applicable
Active, not recruiting
- Conditions
- The objective of this study is to evaluate the efficacy of Soundarya Night Elixir on healthy human subjects for age defying parameters.
- Registration Number
- CTRI/2022/07/044457
- Lead Sponsor
- Mountain Valley Springs India Pvt Ltd
- Brief Summary
It is a single centre, prospective, open label,non-comparative cosmetic study to evaluate the efficacy of Soundarya NightElixir formulation to evaluate age defying parameters like reduce wrinkles& lifting, restores elasticity illuminates & hydrate skin in 50 healthyadult participants. This study will be conducted in compliance with applicablenational regulations for Post Marketing Surveillance of cosmetic product withthe aim of identifying or quantifying safety hazards relating to an authorizedcosmetic product and is aligned with various guidelines and recommendations forguideline 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
- 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.
- Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar etc) 5.
- 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 0 minutes, discharge, 20 days and 40 days after test product application
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Qaaf Healthcare International
🇮🇳South, DELHI, India
Qaaf Healthcare International🇮🇳South, DELHI, IndiaDr Esha RoyPrincipal investigator9254425442dresharoy5@gmail.com