CTRI/2024/07/070779
Not Yet Recruiting
N/A
To evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers with varied skin - NI
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC LIMITED
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Female and male Asian Indian subjects.
- •2\)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
- •3\)Subjects who have not participated in a similar investigation in the past eight weeks.
- •4\)Subjects representing varied skin types
Exclusion Criteria
- •1\)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.
- •2\) Having eczema, psoriasis, lichen planus, vitiligo etc. in the concerned area.
- •3\)Having healing disorder in the concerned area.
- •4\)Having rhinitis, allergic conjunctivitis, or rhino sinusitis.
- •5\) Having an allergy to perfumes and/or preservatives in cosmetic products.
- •6\)Having an allergy to plaster / adhesives used in plaster.
- •7\) Having a food allergy.
- •8\)Having a cardiovascular pathology that requires beta blocking treatments.
- •9\)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
- •10\)Taking a retinoid\-based treatment by general or oral route.
Outcomes
Primary Outcomes
Not specified
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