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

Phase 1

Completed

• Conditions: Transdermal drug delivery; Musculoskeletal conditions; Musculoskeletal - Other muscular and skeletal disorders; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12608000574347
• Lead Sponsor: Phosphagenics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Inclusion Criteria:
1. Mare or female, aged between 18 to 55 years, inclusive.
2. Healthy, defined as free from clinically significant illness or disease as determined by their medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory determinations.
3. Have Body Mass Index (BMI) 19-30kg/m2 and weight > 50 kg.
4. Have adequate venous access on left or right arm to allow collection of a number of samples.
5. Are willing to undergo frequent blood sampling.
6. Fluent in the English language.
7. Able to understand and sign the written Informed Consent Form.
8. Willing to follow the protocol requirements and comply with protocol restrictions.
9. Individuals free of any dermatological or systemic disorder that will interfere with the results, at the discretion of the Investigator.

Exclusion Criteria

Exclusion Criteria:
1. Hypersensitivity to, or persons considered at increase risk of hypersensitivity to diclofenac; other non-steroidal anti-inflammatory drugs (NSAIDS) such as arylalkanoic acids (indomethacin), salicylates (aspirin), profens (ibuprofen), fenamic acids, pyrazolidine derivates (phenazone), ozicams (piroxicam), COX-2 inhibitors (celecoxib), sulphonanilides (nimesulid); propylene glycol, isopropyl alcohol or other ingredients of the gel; or any other medications.
2. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs or any other medications.
3. Treatment with any medication that may mask or interfere with the results, including: another non-steroidal anti-inflammatory drug (NSAIDS), aspirin, corticosteroids, cyclosporine, methotrexate, digoxin, lithium, warfarin or any other anticoagulants or blood thinning medications.
4. Participation in any clinical trial during the 30 days preceding the screening period for this trial.
5. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in section 9.4.6 from at least 14 days prior to the first dose of trial medication until completion of follow-up procedures.
6. Blood donation within 28 days prior to screeing.
7. is planning to have surgery, including dental surgery at any point during the trial.
8. Individuals diagnosed with chronic, contagious viral infections such as Human Immunodeficiency Virus (HIV), hepatitis or herpes.
9. Participants diagnosed with diabetes mellitus, stomach and/or duodennal ulceration or gastrointestinal bleeding, hemorrhoids, inflammative intestinal disorders such Crohn's disease or ulcerative colitis, kidney stones, renal insufficiency, cardiovascular failure, fluid retention (swelling of feet or edema), anemia, hepatic porphyria, asthma, epilepsy, Parkinson's disease or any disease that would increase the risk associated with study participation.
10. Participants with a history of any form of skin cancer, melanoma, lupus, psoriasis, connective tissue disease, diabetes or any disease that would increase the risk associated with study participation.
11. Individuals diagnosed with chronic skin allergies.
12. Individuals with blemishes, nevi, sunburn, suntan, scars, moles, active dermal lesions, uneven pigmentation in the test sites.
13. Individuals with known hypersensitivity to cosmetic products in general and moisturizers in particular.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the single dose pharmacokinetics of TPM/Diclofenac HS and TPM/Diclofenac LS. Eight blood samples will be collected in Periods 1, 2 and 3 for assessment of systemic pharmacokinetics.[Weeks 1, 2 and 3: 8 Blood samples on each study day for plasma pharmacokinetics with be collected pre-dose, then 0.5, 1, 2, 3, 4, 5 and 6 hours post-dose.]