Last updated: 11/03/2018 22:42:11
Effect of topical application of Iodex® balm on local surface temperature
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Time to Significant Increase in Local Surface Temperature
Timeframe: Every minute from baseline to 10 minutes
Secondary outcomes:
Not applicable
Interventions:
Drug: IODEX® balm
Other: Placebo balm
Enrollment:
15
Observational study model:
Not applicable
Primary completion date:
2015-09-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pain
Product
GR53318, GSK3417943, GW407501, SB271004, SB271029, SB274402
Collaborators
Not applicable
Study date(s)
May 2015 to June 2015
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
35 - 65 years
Accepts healthy volunteers
No
- 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
- Women of child bearing potential, pregnant and lactating women
- Intolerance/hypersensitivity to study material/ingredient
Inclusion and exclusion 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
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-09-06
Actual study completion date
2015-09-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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