A prospective dermatological cosmetic study to evaluate the skin care formulations (Ojas Beauty Balm) on various skin parameter in healthy participants
- Registration Number
- CTRI/2022/07/044112
- Lead Sponsor
- Mountain Valley Springs India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
1. Having refused to give her consent by not signing the consent form. Taking part in another study liable to interfere with this study.
2. 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.
6. 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.Timepoint: Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI