Effect of Topical Application of Iodex® Balm on Local Surface Temperature

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Other: Placebo balm; Drug: IODEX® balm

Study type: Interventional

Funder types: Industry

Identifiers

NCT02424565

204663

Details and patient eligibility

About

The rationale of this study is to map out changes in temperature distribution brought about by topical application of our test product, and use this physiological phenomenon to visualize the onset of action involved in overall mechanism of action of the product.

Enrollment: 15 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants suffering from chronic osteoarthritis of knee joint (as per American College of Rheumatology criteria) for > 3 months
• Participants in good general and mental health with no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion criteria

• Women of child bearing potential, pregnant and lactating women
• Intolerance/hypersensitivity to study material/ingredient
• Recent history of alcohol or drug abuse
• Participants receiving topical non-steroidal antiinflammatory drugs (NSAIDs), other topical analgesics/counterirritants/mineral oils, or other medication, which might interfere with study results
• Participants having psoriasis/active atopic dermatitis/eczema/skin infected lesions/burn/wound at the site of application

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups, including a placebo group

Test

Experimental group

Description:

2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.

Treatment:

Drug: IODEX® balm

Placebo

Placebo Comparator group

Description:

2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.

Treatment:

Other: Placebo balm