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

Study Overview
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Brief Summary
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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.

Official Title
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An Exploratory Study to Assess the Effect of Topical Application of Iodex® Balm on Local Surface Temperature Using Infra Red Thermal Imaging Technique

Conditions
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Pain

Intervention / Treatment
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* Drug: IODEX® balm
* Other: Placebo balm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 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: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint. | Drug: IODEX® balm<br>* 2 ± 0.2 g of test balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications.<br>|
| Placebo Comparator: Placebo<br>2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint. | Other: Placebo balm<br>* 2 ± 0.2 g of placebo balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Significant Increase in Local Surface Temperature | Local surface temperature was measured by the spectral order of colour after application of product. Infra-red camera was used to take 11 images with one just before application of product and remaining 10 images at every minute for first 10 minutes after application of product. IR camera converted the IR energy radiated by the body into electrical impulses, which were then digitally indicated on a spatial temperature map. IR camera represents the temperature distribution in a so-called rainbow or spectral order of colors. The predominant colour will be determined on a 5 point scale based on Thermal Images produced using Infra-Red Thermography (IRT) technique and recorded as either Blue, Green, Yellow, Orange or Deep Orange/Red (In increasing order of temperature). There was an approximate temperature difference of 0.5°C between adjacent colours on the map which was supposed to brought about by application of the product and considered significant. | Every minute from baseline to 10 minutes |