None listed
Conditions
Interventions
Intervention1: Cebhydra Intense: Patch application as per BIS standard.0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volun
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/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 13)Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area 14)Having disorder of the healing (whatever the considered area) 15)Having a rhinitis, allergic conjunctivitis or rhino sinusitis 16)Having an allergy to perfumes and/or preservatives in cosmetic products 17)Having an allergy to plaster 18)Having a food allergy 19)Having a cardiovascular pathology (taking a beta blocker treatment) 20)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc. 21)Taking a retinoid-based treatment by general or oral route 22)Taking specific treatment on the back 23)Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study 24)Having miliaria (prickly heat) on the back. 25)Presenting too many naevi on the back 26)Having high pilosity on the back 27)Having scars, excessive terminal hair or tattoo on the study area 28)Refusing to follow the restrictions below during the study:During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back , Till the follow up period of until T8 days, only water is accepted from the first reading i.e., T2 days (24 hours after the patch removal), Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches), Do not expose the back to the sun.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of sensitization potential at Induction phase using the Draize scale and in Challenge phase using the ICDRG scaleTimepoint: Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 17, Day 19, Day 21, Day 38, Day 39, Day 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) and serious adverse events (SAEs)Timepoint: Day1, Day2, Day 3, Day 4, Day 5, Day 6, Day 7,Day 8, Day 9, Day 10, Day 11, Day 12, Day 13,Day 14,Day 15, Day 16, Day 17,Day 18, Day 19, Day 20, Day 21, Day 36, day 37,Day 38, Day 39, Day 40 | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed