CompletedPhase 1ACTRN12610000412033

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.


Sponsor

Phosphagenics Limited

Enrollment

50 participants

Start Date

May 18, 2009

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 49 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a pain-relief gel applied to the skin to check if it causes irritation or allergic reactions. It is for healthy men and women aged 18 to 49 who are not on any prescription medications and have no skin conditions that would interfere with the test.

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

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)

Australia

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ACTRN12610000412033


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