A single centre study to analyse the safety and efficacy of hair vitalizer containing Bhringraj
- Registration Number
- CTRI/2022/03/040992
- 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
- 50
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.
Hair & scalp is healthy on the studied anatomic unit (free of eczema, wounds,
inflammatory scar etc)
Between 18 to 65 years of age, with normal Hair condition.
Written informed consent signed by the subject in line with applicable regulation
of country.
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 hair & scalp 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 investigatorTimepoint: Subject will be assessmentd Cosmetic products will be applied and will be observed for 30 minutes for any safety concern and the subject will return for follow-up to the investigator/site staff 15 and 30 days after the first application of cosmetic product (HAIR VITALIZER (BHRINGRAJ). Follow-up visits (at 15th and 30th day) can be done telephonically also
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI