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

July 18, 2016 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Indiranagar, Banglador, India, 560038
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every minute from baseline to 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (ESTIMATE)

April 23, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 204663

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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