Phase 4
N=15
Effect of Topical Application of Iodex® Balm on Local Surface Temperature
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02424565 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Time to Significant Increase in Local Surface Temperature
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IODEX® balm (Drug); Placebo balm (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Significant Increase in Local Surface Temperature |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02424565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.