None listed
Conditions
Interventions
Intervention1: Tedibar Ceramax Head to Toe Bodywash (TB003B): 0.04 mL (40 microlitres) of an 8% w/w product solution prepared in distilled water is dispensed into the aluminium chambers of the patch a
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit 3)Having Photo type III to V
Exclusion criteria
Exclusion criteria: 1)For female: Pregnant/nursing mothers 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)Having participated in study in past one month. 5)Being diabetic. 6)Being asthmatic. 7)Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol). 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)Having Scars, excessive terminal hair or tattoo on the studied area. 13)Having Henna tattoo anywhere on the body (in case of studies involving hair dyes). 14)Having Dermatological infection/pathology on the level of studied area. 15)Having Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye). 16)Having any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. 17)Having chronic illness which may influence the outcome of the study. 18)Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). 19)Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitization potentialTimepoint: 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 |
|---|---|
| NilTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed