To know the safety of Investigational products by assessing the irritation after patch application onhealthy human volunteers.
- Registration Number
- CTRI/2022/03/040975
- Lead Sponsor
- ITC LIMITED ITC Life Sciences and Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
1) Healthy Human Subjects
2) Skin should be healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.).
3) Subjects willing to come for regular follow up and ready to follow instructions during the study period.
4) Subjects representing varied skin types (ideally equal representation of all 4 skin types â?? Oily, Normal, Dry and combination)
1) DetailsFor female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2) Having refused to give his/her assent by signing the consent form
3) Taking part in another study liable to interfere with this study
4) Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area
5) Having disorder of the healing
(whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Irritation potential on skinTimepoint: Baseline,0 hrs,24 hrs and 7 days
- Secondary Outcome Measures
Name Time Method not applicableTimepoint: not applicable