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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03743896

Enrollment

240

Registered

2018-11-16

Start date

2016-05-18

Completion date

2017-03-10

Last updated

2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Transdermal Delivery, Glucosamine, Synovial Fluid, Osteoarthritis, Knee, Human, Arthrocentesis

Brief summary

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.

Interventions

DRUGTransdermal Glucosamine Cream

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Masking description

There is no possibility of subjective bias or placebo effect since the primary outcome is the drug concentration in the synovial fluid. Hence no blinding or randomization needed.

Intervention 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)

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Concentration of glucosamine in synovial fluid	1 to 3 hours post-intervention	For the Test group

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026