None listed
Conditions
Interventions
Intervention1: 1. Skin Leave On 2. Skin Leave On 3. Skin Leave On 4. Skin Leave On 5. Skin Leave On 6. Skin Leave On 7. Skin Leave On 8. Skin Leave On 9. Skin Leave On 10. Skin Leave On
: Skin Leave O
Sponsors
ITC Limited ITC Life Sciences Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects in the age group of 18-55 years (both age inclusive) 2. Subjects in good general health 3. Subjects with Fitzpatrick skin type III to V 4.Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannââ?¬•s skin type questionnaire 5.Subject identified to have sensitive skin basis dermatologistââ?¬•s assessment of skin with fine texture and closeness of blood vessels to the surface 6.Subjects willing to give a voluntary written informed consent 7. Subjects willing to maintain the test patches in designated positions for 24 hours 8. Subjects having not participated in a similar investigation in the past eight weeks 9. Subjects willing to come for regular follow up visits 10. Subjects ready to follow instructions during the study period 11. Subjects without any open wounds, cuts, abrasions, irritation symptoms
Exclusion criteria
Exclusion criteria: 1. Subjects with a present condition of allergic response to any cosmetic product 2. Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study 3. Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy) 4. Subjects with cutaneous disease that could interfere with the study results 5. Subjects with chronic illness that may influence the cutaneous state or any other illness including Diabetes, liver disease, HIV or any other serious medical illness 6. Subjects participating in any other cosmetic or therapeutic trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment of investigational products for irritation potential using Draize scaleTimepoint: Safety assessment of investigational products for irritation potential using Draize scale done on 0 hour after patch removal, 24 hours after patch removal and 7 days post patch removal | — |
Secondary
| Measure | Time frame |
|---|---|
| N/ATimepoint: N/A | — |
Countries
India
Contacts
Public ContactRajat Gupta
CIDP Biotech India Pvt Ltd
Outcome results
None listed