Trial Outcomes & Findings for Effect of Topical Application of Iodex® Balm on Local Surface Temperature (NCT NCT02424565)
NCT ID: NCT02424565
Last Updated: 2016-08-29
Results Overview
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.
COMPLETED
PHASE4
15 participants
Every minute from baseline to 10 minutes
2016-08-29
Participant Flow
Participants were recruited at one center in India.
Of the 19 participants screened, 15 were randomized, 14 completed the study.
Participant milestones
| Measure |
First Test Balm Then Placebo Balm
2 ± 0.2 g of test balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of placebo balm of 9g balm packed in each primary package .
|
First Placebo Balm Then Test Balm
2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of test balm of 9g balm packed in each primary package .
|
|---|---|---|
|
Period 1 (D0)
STARTED
|
8
|
7
|
|
Period 1 (D0)
COMPLETED
|
8
|
6
|
|
Period 1 (D0)
NOT COMPLETED
|
0
|
1
|
|
Washout Period
STARTED
|
8
|
6
|
|
Washout Period
COMPLETED
|
8
|
6
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Period 2 (D3)
STARTED
|
8
|
6
|
|
Period 2 (D3)
COMPLETED
|
8
|
6
|
|
Period 2 (D3)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
First Test Balm Then Placebo Balm
2 ± 0.2 g of test balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of placebo balm of 9g balm packed in each primary package .
|
First Placebo Balm Then Test Balm
2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of test balm of 9g balm packed in each primary package .
|
|---|---|---|
|
Period 1 (D0)
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Effect of Topical Application of Iodex® Balm on Local Surface Temperature
Baseline characteristics by cohort
| Measure |
Overall Participants
n=14 Participants
Total number of participants randomized and treated in the study.
|
|---|---|
|
Age, Continuous
|
49.9 Years
STANDARD_DEVIATION 8.0 • n=39 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Every minute from baseline to 10 minutesPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Test Balm
Placebo Balm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER