Transdermal Delivery of Glucosamine to the Synovial Fluid of Male and Female With Knee Osteoarthritis

Study Overview
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Brief Summary
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Glucosamine is commonly used as a treatment for Osteoarthritis (OA). While oral administration remains the most commonly used route, topical administration could offer numerous advantages such as targeted delivery to affected joints and overcoming the negative effects of the passage of the drug through the digestive system. The objective of this study is to assess the bioavailability of glucosamine in the synovial fluid of osteoarthritic joints, following the topical application of a commercially available transdermal glucosamine cream. Joint fluid samples will be collected from 2 groups of participants with knee OA: the Control group will not be subjected to any treatment while the Test group will apply 2g of transdermal glucosamine cream 1 to 3 hours before the joint fluid collection. Glucosamine concentration will be determined and the results obtained from both groups will be compared. This trial will potentially provide data to support that glucosamine can cross the skin and be delivered to the affected joint fluid when formulated in a transdermal cream base.

Official Title
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An Open Label, Single Dose, Bioavailability Study of Topical Transdermal Glucosamine Cream on the Synovial Fluid Tapped From Osteoarthritic Adult, Male and Female Human Subjects Already Undergoing Arthrocentesis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Transdermal Glucosamine Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and non-pregnant female human subjects 21 to 80 years old Subjects who need to undergo arthrocentesis (prescribed during prior medical assessment) Willingness to follow the protocol requirements Exclusion Criteria: Known allergy to shellfish Known history of hypersensitivity to Glucosamine or related drugs. Known history of hypersensitivity to Capsaicin (Capsicum extract) Known history of skin sensitivity Subjects who have taken any kind of glucosamine during the last 24 hours Subjects who have taken any kind of treatment for joint pain during the last 24 hours Subjects having scars/cut/dermatological abnormality at application site Pregnant or nursing women

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects who agreed to participate in the study could decide to be part of the Control group (no intervention) or the Test group (single dose, topical application of Transdermal Glucosamine Cream)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No intervention | |
| Experimental: Test group<br>single dose (2g), topical application of Transdermal Glucosamine Cream (containing 10% w/w of glucosamine sulfate) | Drug: Transdermal Glucosamine Cream<br> <br> * Other names: TGC® Plus Capsaicin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of glucosamine in synovial fluid | For the Test group | 1 to 3 hours post-intervention | 
| Concentration of glucosamine in synovial fluid | For the Control group | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transdermal Delivery, Glucosamine, Synovial Fluid, Osteoarthritis, Knee, Human, Arthrocentesis