An evaluation of the irritation and sensitization of an opioid analgesic gel applied to the skin in healthy volunteers.

Phase 1

Completed

• Conditions: Irritation; Sensitization; Skin - Dermatological conditions

• Registration Number: ACTRN12610000412033
• Lead Sponsor: Phosphagenics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male and female participants aged 18 to 49 years inclusive.
2. Participants who are not presently and have not for a period of 30 days prior to screening, been under the influence of prescription medication.
3. Able to read, understand and adhere to the study visits and procedures.
4. Participants who provide written informed consent for participation in this study.

Exclusion Criteria

1. Participants who, in the opinion of the investigator, may express a negative reaction to a test sample based upon medical history or other pre-test conditions.
2. Pregnant or lactating females. Females of child bearing potential who do not agree to use highly effective methods of birth control.
3. Participants currently under a doctor's care.
4. Participant who intend to become pregnant within the next 60 days.
5. Participants who have taken any anti-inflammatories, anti-histamines, steroids (topical or oral) or prescription medication within 30 days prior to screening (not including sunscreen), with the exception of contraception for females; or any over the counter medications within 48 hours prior to screening;
6. Participants who exhibit physical or dermatological conditions, which would preclude application of the test material.
7. Known allergy or hypersensitivity reactions to oxycodone or other opioid analgesics or allergy to any contents of the gel.
8. Known allergy or hypersensitivity to tapes, patches, adhesives or to topical preparations, such as sunscreens.
9. Participants who have participated in a clinical trial or received an experimental therapy within 30 days prior to dosing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the irritation and sensitization of tocopheryl phosphate mix combined with oxycodone (TPM/O) after transdermal applications.<br>Visual evaluations of skin reactions will be scored according to a skin response table.[After removal of patches and immediately prior to each subsequent dose on days 1, 3, 5, 7, 9, 11, 13, 15, 17 and 28.]

Secondary Outcome Measures

Name	Time	Method
n/a[n/a]