A Phase IIa safety study of topical R-flurbiprofen in patients with a history of non-melanoma skin cancer

A randomised, double blind, placebo controlled, Phase IIa study of the safety of R-flurbiprofen administered as a topical gel to patients with a history of non-melanoma skin cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000192583

Enrollment

Registered

2006-05-24

Start date

2006-08-01

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

This Phase IIa trial will assess the safety and tolerability of a topical gel containing 1% R-flurbiprofen, when applied to the skin of subjects with a history of non-melanoma skin cancer. This will be a double-blind, randomised, placebo-controlled trial. All subjects and study personnel will be blinded, except for the person allocating the active or placebo tubes to each subject, based on the randomisation schedule. Thirty subjects will receive the R-flurbiprofen gel, and 10 will receive a placebo gel. The gel will be applied topically once daily, for 28 consecutive days, to the face, ears, neck, forearms and hands. The primary outcome measure will be skin irritation at the site of gel application. Lay statement: This trial will test the safety of a gel when applied to the skin of people who have had at least one non-melanoma skin cancer. A future trial will test if this gel can prevent, or reduce the occurrence of, non-melanoma skin cancer.

Interventions

This trial will assess the safety and tolerability of a topical gel containing 1% R-flurbiprofen, when applied to the skin of subjects with a history of non-melanoma skin cancer. This will be a double-blind, randomised, placebo-controlled trial. Thirty subjects will receive the R-flurbiprofen gel. The gel will be applied topically once daily, for 28 consecutive days, to the face, ears, neck, forearms and hands.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

Must have had at least one non-melanoma skin cancer in the past 5 years.

Exclusion criteria

Any significant medical disorder;Current use of NSAIDs (and unwilling to cease use).

Outcome results