SENSITISATION TEST

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.
Procedura:	Induction phase: • 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. Challenge phase: • 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.