A dermatological study to evaluate the skin care formulations (intensive eye cream) for skin like reduce dry & dehydrated lines, clears, brightens, smoothens and nourishes the eye area, brightens dark circles, improve under eye puffiness on healthy participants.
Not Applicable
Active, not recruiting
- Conditions
- The objective of study is to evaluate the Dermatological efficacy with skin care formulations (intensive eye cream) on healthy participants
- Registration Number
- CTRI/2022/07/044410
- Lead Sponsor
- Mountain Valley Springs India Pvt Ltd
- Brief Summary
It is a single center, prospective study to evaluate efficacyand safety of skin care formulations (INTENSIVE EYE CREAM) 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
- 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) 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 Assessment will be done at 30 min, 20 days and 40 days of 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