CompletedPhase 1ACTRN12608000574347

A proof of concept study comparing the skin penetration abilities of the novel penetration enhancer Tocopheryl Phosphate Mix (TPM)/Diclofenac compared with Voltaren Gel

A Phase I study to assess the bioavailability of topically applied Diclofenac in combination with the novel penetration enhancer Tocopheryl Phosphate Mix (TPM), compared with Voltaren Gel in 12 healthy male or female participants.

Sponsor

Phosphagenics Limited

Enrollment

12 participants

Start Date

Oct 17, 2008

Study Type

Interventional

Conditions

Transdermal drug delivery

Summary

The purpose of this study is to compare the penetration of Diclofenac with the penetration enhancer Tocopheryl Phosphate Mix (TPM) across intact skin against a currently marketed treatment Voltaren Gel. For the first visit you will be randomly allocated to receive a topical application of one of TPM/Diclofenac HS, TPM/Diclofenac LS or Voltaren Gel applied to your back. At the second visit you will receive a topical application of another one of TPM/Diclofenac HS, TPM/Diclofenac LS or Voltaren Gel, different to the treatment you received at the first visit. At the third visit you will receive a topical application of the other one of TPM/Diclofenac HS, TPM/Diclofenac LS or Voltaren Gel, different to the treatments you received at the first and second visits. At the fourth visit, you will receive all three treatments and undergo a procedure called skin stripping to evaluate how well Diclofenac penetrates the skin. For each of the visits you will stay at the study centre for approximately 6 hours after the gel has been applied. You will then be required to return to the study centre for approximately 1 hour for a follow up visit. Blood samples will be collected in visits 1, 2 and 3 (8 samples per visit) by either cannula or venipuncture. A total of 192 mL of blood will be collected during the study, which includes the amount required for the clinical laboratory tests and for the measurement of Diclofenac in your blood.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares a new skin-penetrating pain relief gel containing diclofenac with the standard Voltaren Gel to see which delivers the medication through the skin more effectively. Healthy adults aged 18 to 55 with a normal BMI are eligible. People with skin conditions, allergies to anti-inflammatory drugs, or chronic diseases cannot participate.

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

Subjects will be dosed once a week over a 4 week period and will receive each treatment regime. Subjects will be randomised at their Period 1 Visit (Day 1) to receive either a single dose of 1.0g TPM

Subjects will be dosed once a week over a 4 week period and will receive each treatment regime. Subjects will be randomised at their Period 1 Visit (Day 1) to receive either a single dose of 1.0g TPM/Diclofenac HS (high solvent), a single dose of 2.0g TPM/Diclofenac LS (low solvent) or the reference treatment, a single dose of 2.0g Voltaren Gel. This single dose equates to an applied dose of 20mg of Diclofenace. The single topical dose will be applied to the subjects back area at their Period 1 Visit (Day 1). At the Period 2 Visit (Day 8) subjects will have been randomally allocated to receive either a single dose of 1g TPM/Diclofenac HS (high solvent), a single dose of 2.0g TPM/Diclofenac LS (low solvent) or the reference treatment, a single dose of 2.0g Voltaren Gel. This single dose equates to an applied dose of 20mg of Diclofenace. This treatment will be an alternate treatment to the treatment they received at their Period 1 Visit. Subjects will receive a single topical dose to their back area at their Period 2 Visit (Day 8). At the Period 3 Visit (Day 15) subjects will have been randomally allocated to receive either a single dose of 1.0g TPM/Diclofenac HS (high solvent), a single dose of 2.0g TPM/Diclofenac LS (low solvent) or the reference treatment, a single dose of 2.0g Voltaren Gel. This single dose equates to an applied dose of 20mg of Diclofenace. This treatment will be an alternate treatment to the treatments they received at their Period 1 and 2 Visits. Subjects will receive a single topical dose to their back area at their Period 3 Visit (Day 15). Therefore over Periods 1, 2 and 3 Visits subjects will have received a single dose of all three treatments TPM/Diclofenac HS (high solvent), TPM/Diclofenac LS (low solvent) and the reference treatment Voltaren Gel in a randomised cross-over design. At the Period 4 Visit (Day 22) subjects will receive all three treatments TPM/Diclofenac HS (high solvent), TPM/Diclofenac LS (low solvent) and the reference treatment Voltaren Gel simultaneously to 3 different areas of their back on this Visit 22 study day. Approximately 31.25mg of TPM/Diclofenac HS Gel will be applied topically to the first area of the the subject's back, approximatley 62.5mg of TPM/Diclofenac LS Gel will be applied topically to the second area of the subject's back and 62.5mg of the reference treatment Voltaren Gel will be applied topically to the third area of the subject's back. This equates to a total applied dose of 2.5mg of diclofenac for each formulation (7.5mg total).

Locations(1)

Australia

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ACTRN12608000574347