A prospective dermatological study of cosmetic cream containing Date & Litchi to evaluate the skin parameters like revitalizes, nourishes, plumps & lifting, enhances & retains skin hydration on healthy volunteers
Not Applicable
Active, not recruiting
- Conditions
- The objective of this study is to evaluate the Dermatological efficacy of cosmetic cream containing Date & Litchi on healthy volunteers
- Registration Number
- CTRI/2022/07/044183
- 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 **cosmetic cream containing Date & Litchi** to to evaluate the parameters like revitalizes, nourishes, plumps& lifting, enhances & retains skin hydration with skin careformulations 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
- 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.
- Between 20 to 65 years of age, with normal skin texture.
- Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 5.
- Written informed consent signed by the subject or legally acceptable representative(s) in line with applicable regulation of country.
Exclusion Criteria
- Having refused to give her assent by not signing the consent form 2.
- Taking part in another study liable to interfere with this study 3.
- Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 4.
- Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products 5.
- 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 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 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 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 The evaluation of the skin acceptability will be carried out by the Physician at T0, T+30 minutes after test product application, T+20-days, T+40 days was based on the discussion with the subject and on a clinical examination. Subject Assessment will be done at 30 minutes, 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