None listed
Conditions
Interventions
Intervention1: Cebhydra Intense: Patch application as per BIS standard. A Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep a
Sponsors
Sun Pharmaceutical Industries Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1)Female and male Asian Indian subjects with phototype III-V. 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 (e.g., free of eczema, wounds, inflammatory scar) 5)Subjects representing sensitive skin type (as per the Baumann s questionnaire answered by subjects)
Exclusion criteria
Exclusion criteria: 1)For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2)Having eczema, psoriasis, lichen planus, vitiligo at the test site of analysis. 3)Having disorder of the healing at the test site of analysis 4)Having rhinitis, allergic conjunctivitis or rhino sinusitis 5)Having hypersensitivity/ allergy to any cosmetics, perfumes and/or conservatives in cosmetic products, etc. 6)Having an allergy to plaster 7)Having a food allergy 8)Having scar excessive terminal hair or tattoo on studied area 9)Having a cardiovascular pathology (taking a beta blocker treatment) 10)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc. 11)Taking a retinoid-based treatment by general or oral route 12)Taking specific treatment on the back. 13)Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study 14)Having miliaria (prickly heat) on the back. 15)Presenting too many naevus on the back 16)Having high pilosity on the back. 17)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 use of water is acceptable 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 |
|---|---|
| Mean score calculation for assessment of irritation potential (i.e., erythema, scaling, dryness wrinkling & oedema)Timepoint: 24 hours after the patch removal | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) and serious adverse events (SAEs) reported by the subject and the dermatologist, throughout the studyTimepoint: Baseline, 24 hours after patch application, 24 hours after patch removal, week after patch removal | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed