|Titlu:||Human Repeated Insult Patch Test (HRIPT) – Final Safety Clinical Test (FSCT).|
|Obiective:||To confirm the absence of delayed contact sensitisation potential and assess the skin compatibility of a product after repeated applications under maximalising conditions.|
|Planificare:||Duration of the study: 6/8 weeks.
Beginning: According to annual schedule (several panels once a month).
Report: 2/3 weeks after the end of the study.
|Metodologie:||Clinical assessment of the cutaneous response, according to adapted method of Marzulli & Maibach or Shelanski.|
• Skin examination of application site.
• Application of the product to the back of the subjects 3 times per week for 3 consecutive weeks under occlusive or semi occlusive patch (according to its composition and/orcategory or class of product).
• Patch removal after 24/48 or 72 hour-contact with the skin.
• Skin examination of the application site after each patch removal.
Rest period: 2 consecutive weeks at least (4 weeks at the most) with no product application.
• Single application of the product under patch to the induction site and to a virgin site.
• Patch removal after 24 / 48 hour-contact with the skin.
• Skin examination of the application sites before application and at least 15 minutes/24 hours/48 hours/72 hours/96 hours after patch removal.