safety testing of Investigational products by assessing the irritation after patch application onhealthy human volunteers.
- Registration Number
- CTRI/2018/01/011525
- 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
- 24
Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.)
Subjects representing varied skin types (ideally equal representation of all 4 skin types â?? Oily, Normal, Dry and combination) Subjects willing to come for regular follow up and ready to follow instructions during the study period
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the dermatological safety of <br/ ><br>investigational products by primary irritation <br/ ><br>patch test on healthy human volunteers of varied <br/ ><br>skin types <br/ ><br>Timepoint: T0, T1, T2 AND T8
- Secondary Outcome Measures
Name Time Method not applicableTimepoint: not applicable