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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: IODEX® balm; Other: Placebo balm

• Registration Number: NCT02424565
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-23
• Study Start: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Status Verified: 2016-02
• Results First Submitted: 2016-02-04
• Results First Submitted QC: 2016-07-18
• Last Update Submitted: 2016-07-18
• Results First Posted: 2016-08-29
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test	IODEX® balm	2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.
Placebo	Placebo balm	2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.

Primary Outcome Measures

Name	Time	Method
Time to Significant Increase in Local Surface Temperature	Every minute from baseline to 10 minutes	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇮🇳 Indiranagar, Banglador, India