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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000412033

Enrollment

Registered

2010-05-21

Start date

2009-05-18

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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).

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 49 Years

Healthy volunteers

Yes

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.

Outcome results