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Clinical Testing of Phototoxicity & Photosensitisation

Clinical Testing of Phototoxicity & Photosensitisation

Prove that your ingredients are safe for use in an in vivo situation when the product is exposed to UV light and allows you to make safety claims for the consumer on the packaging and advertisements.

Claims Substantiated:

  • Non-Phototoxic, Non-Photosensitive

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Briefly, what you can expect

Phototoxicity Test:

  • A phototoxicity test comprises 10 healthy male and female subjects to investigate the skin phototoxic potential of 1 test article plus 2 standard controls.
  • Active Phase: patch is applied four times with 23 hours between each patch to the subject with UV exposure implemented 1 hour after each patch removal. Scoring of any reactions takes place 24 hours after the first, second, third and fourth UV exposure.
  • We have various patch types and adhesive materials to use depending on whether we are performing a fully-occlusive or semi-occlusive study.

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Photosensitization Test:

  • A photosensitization test takes a minimum of 25 subjects over a 6 week study period.
  • Active Phase: Induction patches containing “Finn Chambers” are applied on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19. UV exposures are then performed on Days 3, 5, 8, 10, 12, 15, 17, 19 and 22,  followed 24 hours later by skin assessments. Challenge patches are applied on Day 36 to a naive skin site. UV exposures are then performed on Days 38 and 40 followed 24 hours later by Challenge assessments.
  • We use various patch types and adhesive materials depending on whether we are performing a fully-occlusive or semi- occlusive study.