Registration Dossier
Registration Dossier
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EC number: 432-770-2 | CAS number: 139189-30-3
Endpoint summary
Administrative data
Description of key information
According to the methodology used to assess the skin sensitization potential of the product PX-200, it could be concluded that:
-During the study, no subjects presented skin clinical signs related to the product.
-The product did not induce a skin sensitization process in the study group.
-The product was considered safe under the study conditions.
Additional information
STUDY OBJECTIVE
To prove the absence of the skin sensitization potential of a product applied to the skin, under maximized conditions, with controlled product amount and application site, supervised by a dermatologist.
METHODOLOGY
Both the test-product and control were applied to patch test filter paper discs and then applied to the right or left back (scapular area) of the study subjects. The applications were performed on Mondays, Wednesdays and Fridays, during 3 consecutive weeks. Forty-eight hours (48h) after the application, the patch test was removed by trained technicians and, approximately 30 minutes after the patch test removal, the site was assessed in order to check the presence of possible clinical signs.
After this period (induction) there was a, minimum, 10 day-period when no patch was applied to the study subjects' back (rest period).
Then, the challenge period started. A single application of the patch test was performed, followed by readings after 48h and 72h.
The study subjects were assessed by a dermatologist at the start and at the end of the study and supervised all along the study.
STUDY LENGTH
6 weeks.
FREQUENCY OF APPLICATION
9 applications on the 3 first weeks (induction period).
1 application on the last week (challenge period).
APPLICATION SITE
Back (Scapular area).
NUMBER OF SUBJECTS
58 study subjects.
POPULATION DESCRIPTION
Female and male, age range from 18 to 67 years old, phototype II to IV (Fitzpatrick).
ETHICS
This study was conducted in conformance with the Declaration of Helsinque principles, the applicable regulatory requirements, including Resolution CNS no. 466/12, and in spirit of the Good Clinical Practices (Document of the Americas and ICH E6: Good Clinical Practice).
RESULTS
During the study, no subjects presented skin clinical signs related to the product.
CONCLUSION
The product did not induce a skin sensitization process in the study group.
The product was considered safe under the study conditions.
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