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

NCT02424565 | Completed Phase 4 Results

• 1 other identifier: 204663
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test

EXPERIMENTAL

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

Drug: IODEX® balm

Placebo

PLACEBO COMPARATOR

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

Other: Placebo balm

Interventions

IODEX® balm DRUG

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.

Test

Placebo balm OTHER

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.

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Indiranagar, Banglador, 560038, India

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Primary outcome measure was to detect significant increase in surface temperature. Since this was not observed for either treatment, there was no statistical analysis comparing the two arms.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 23, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 29, 2016
• Results First Posted: August 29, 2016

Record last verified: 2016-02

Locations

IN (1)