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

Lynk Biotechnologies

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Drug: Transdermal Glucosamine Cream

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03743896

CTC1600169 (Registry Identifier)

ASC/CPROJ/14/15/16

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Control group

No Intervention group

Description:

No intervention

Test group

Experimental group

Description:

single dose (2g), topical application of Transdermal Glucosamine Cream (containing 10% w/w of glucosamine sulfate)

Treatment:

Drug: Transdermal Glucosamine Cream