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

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ClinicalTrials.gov Identifier: NCT02424565
Recruitment Status : Completed
First Posted : April 23, 2015
Results First Posted : August 29, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Drug: IODEX® balm Other: Placebo balm Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: An Exploratory Study to Assess the Effect of Topical Application of Iodex® Balm on Local Surface Temperature Using Infra Red Thermal Imaging Technique
Study Start Date : May 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Test
2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.
 Drug: IODEX® balm
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.
Placebo Comparator: Placebo
2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.
 Other: Placebo balm
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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to Significant Increase in Local Surface Temperature [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424565


Locations
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India
GSK Investigational Site
Indiranagar, Banglador, India, 560038
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02424565    
Other Study ID Numbers: 204663
First Posted: April 23, 2015    Key Record Dates
Results First Posted: August 29, 2016
Last Update Posted: August 29, 2016
Last Verified: February 2016