None listed
Conditions
Interventions
None listed
Sponsors
Mountain Valley Springs India Pvt Ltd
Eligibility
Inclusion criteria
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. 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.
Exclusion criteria
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 hair & scalp cleaned with water is accepted).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactMr Nishant Singh
Mountain Valley Springs India Pvt. Ltd.
Outcome results
None listed