None listed
Conditions
Interventions
Intervention1: Vatika Henna HAIR COLOUR Henna & Coffee (EPV30036): 1:4 solution of the investigational product is prepared in distilled water. 0.04 ml of test samples is applied on the previously mark
Sponsors
Dabur International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Asian Indian male and female subjects 2) Healthy human subjects (no infectious and evolutive 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) 3) Between 18 and 65 years of age 4) Skin is healthy on the studied anatomic unit (free of eczema,wounds, inflammatory scar….) 5)subjects who show no allergic / irritation symptoms to the test product at skin sensitivity test will be enrolled in the study.
Exclusion criteria
Exclusion criteria: 1 For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give his/her assent by not signing the consent form 3 Taking part in another study liable to interfere with this study 4 Being diabetic. 5 Being asthmatic. 6 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). 7 Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin). 8 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 9 Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dermatological safety / Irritation potential on skinTimepoint: Baseline,0 hrs,24 hrs and 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed