An evaluation of the irritation and sensitization of an opioid analgesic gel applied to the skin in healthy volunteers.
A repeat insult patch test (RIPT) to evaluate the irritation and sensitization of transdermally delivered oxycodone in combination with the novel penetration enhancer, tocopheryl phosphate mix (TPM) in healthy volunteers.
Phosphagenics Limited
50 participants
May 18, 2009
Interventional
Conditions
Summary
The purpose of this study is to determine if tocopheryl phosphate mix, in combination with oxycodone (TPM/O) in the form of a patch, will cause irritation when applied daily for a long period of time (9 consecutive days).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The study consists of 1 test group. A gel containing Tocopheryl phosphate mix in combination with approximately 9 mg of oxycodone (TPM/O). TPM/O will be applied and covered using an occlusive patch to 50 healthy volunteers for a series of nine consecutive 24 hour exposures, every day.
Locations(1)
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ACTRN12610000412033