None listed
Conditions
Interventions
Intervention1: FW 134: Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal).
Int
Sponsors
ITC Limited Peenya Industrial Area Peenya Bangalore
Eligibility
Inclusion criteria
Inclusion criteria: 1.Volunteer (female/ male) in generally good health. 2.Volunteer between the ages of 18 and 50 years. 3.Volunteer has not participated in a similar clinical investigation in the past four weeks. 4.Volunteer willing to give a written informed consent and come for regular observation.
Exclusion criteria
Exclusion criteria: 1.A known history or present condition of allergic response to any cosmetic products. 2.Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings. 3.Medications (e.g. steroids or antihistamines), which would compromise the study. 4.Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| irritation potentialTimepoint: first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hrs and 1 week of patch removal | — |
Secondary
| Measure | Time frame |
|---|---|
| investigational products to be tested for irritancy testTimepoint: On each subjectââ?¬â?¢s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). | — |
Countries
India
Contacts
Public ContactMs Vaishali Dhavan
Outcome results
None listed