None listed
Conditions
Interventions
Intervention1: Xerina Roll On: 0.04 ml of test samples is dispensed into the aluminium chambers of the patch and applied on the volunteers backs at the T0 visit. There will be a total of 10 applicat
Sponsors
Sun Pharmaceutical Industries Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female and male Asian Indian 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 checkup) 3.Between 18 and 65 years of age. 4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
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 or 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, anti histamines, 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. 10)Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 11)The day of the patch application: no cosmetic product must be used (test site clean with water only). 12)Refusing to follow the restrictions below during the study, For female Do not become pregnant nor breastfeed, Do not take part in another study liable to interfere with this study, Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol), Do not change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitization potentialTimepoint: Baseline, T2, T4, T6, T9, T11, T13, T16, T18, T20, T23, T24, T25 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) and serious adverse events (SAEs)Timepoint: Baseline, T2, T4, T6, T9, T11, T13, T16, T18, T20, T23, T24, T25 | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed