None listed
Conditions
Interventions
Intervention1: 13-133: A single application of about 0.04ml of product is applied under semi-occlusion for 24hrs on the subjects back.
Intervention2: 13-139A: A single application of about 0.04ml of p
Sponsors
ITC LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1)Female and male Asian Indian subjects. 2)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 3)Subjects who have not participated in a similar investigation in the past eight weeks. 4)Subjects representing varied skin types
Exclusion criteria
Exclusion criteria: 1)For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis. 2) Having eczema, psoriasis, lichen planus, vitiligo etc. in the concerned area. 3)Having healing disorder in the concerned area. 4)Having rhinitis, allergic conjunctivitis, or rhino sinusitis. 5) Having an allergy to perfumes and/or preservatives in cosmetic products. 6)Having an allergy to plaster / adhesives used in plaster. 7) Having a food allergy. 8)Having a cardiovascular pathology that requires beta blocking treatments. 9)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc. 10)Taking a retinoid-based treatment by general or oral route. 11)Taking specific treatment on the back. 12) Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study. 13)Having miliaria (prickly heat) on the back. 14) Presenting too many neavi on the back. 15) Having high pilosity on the back.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome TimePoints Dermatological safety / Irritation potential on skinTimepoint: Baseline,0 hrs,24 hrs & 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed