Pain
Conditions
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.
Interventions
DRUGIODEX® 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.
OTHERPlacebo 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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Significant Increase in Local Surface Temperature | 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. |
Countries
India
Participant flow
Recruitment details
Participants were recruited at one center in India.
Pre-assignment details
Of the 19 participants screened, 15 were randomized, 14 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Total number of participants randomized and treated in the study. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (D0) | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 49.9 Years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
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.
Time frame: Every minute from baseline to 10 minutes
Population: Intent-to-treat (ITT) population included all participants of safety population with any post-treatment assessment. Since no significant increase in surface temperature was observed in subjects for either treatment, therefore, number of subjects analyzed for this outcome is zero.