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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424565
• Other study ID #: 204663
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2015
• Last updated: December 21, 2015
• Start date: May 2015
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain

Intervention

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.

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.

Locations

Country	Name	City	State
India	GSK Investigational Site	Indiranagar, Banglador

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to significant increase in local surface temperature	Local surface temperature is measured by the spectral order of colour after application of product. Infra-red (IR) camera are 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 convert the IR energy radiated by the body into electrical impulses, which are then digitally indicated on a spatial temperature map. There is an approximate temperature difference of 0.5°C between adjacent colours on the map. Significance is established if there is an increase of minimum 0.5°C after application of the product. The earliest time to bring about a significant increase in temperature is compared between test and placebo.	Every minute from baseline to 10 minutes	No