A phase 1 study in healthy volunteers to determine the dermatopharmacokinetics of topically applied diclofenac in combination with the novel penetration enhancer Tocopheryl Phosphate Mixture (TPM), compared with Votaren(registered trademark) gel

A phase 1 study in healthy volunteers to determine the dermatopharmacokinetics of topically applied diclofenac in combination with the novel penetration enhancer Tocopheryl Phosphate Mixture (TPM), compared with Votaren (registered trademark) gel

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000505202

Enrollment

Registered

2009-06-24

Start date

2008-10-17

Completion date

2008-12-18

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 study is being conducted to see if a TPM/Diclofenac gel mix will penetrate into the skin more, and more quickly, than Voltaren. It will also assess how safe the gel mix is.

Interventions

A gel mixture of Tocopheryl Phosphate Mixture (TPM) and Diclofenac 1% and 2% applied topically to the volar forearms once for a 6 hour period. Each subject will receive 4 applications of 62.5mg each of each concentration

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy males and females aged 18 to 55 years inclusive.

Exclusion criteria

Pregnant or breast-feeding, skin conditions preventing gel application, current clinically significant medical conditions, on chronic medications, on medications which may interact with non-steroidal anti-inflamatory drugs

Outcome results