Trial Outcomes & Findings for Effect of Topical CBD Cream for Degenerative Hallux Disorders (NCT NCT04103814)
NCT ID: NCT04103814
Last Updated: 2024-10-15
Results Overview
Weekly visual analog system (VAS) pain scores will be measured daily for four weeks. The VAS pain score is a measure of pain severity. It is measured on a scale from 0 to 10, with 10 being the worst pain the patient has experienced. No patients completed full enrollment so no data was analyzed.
TERMINATED
PHASE2/PHASE3
11 participants
4 weeks
2024-10-15
Participant Flow
Participant milestones
| Measure |
CBD Cream
Patients will be treated with CBD cream
|
Control
Patients will be treated with a placebo cream not containing CBD
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
No data were collected/analyzed
Baseline characteristics by cohort
| Measure |
CBD Cream
n=8 Participants
Patients will be randomized to CBD cream
|
Control
n=3 Participants
Patients will be randomized to a placebo cream without CBD
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
|
Age, Categorical
>=65 years
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
|
Sex: Female, Male
Female
|
0 Participants
No data were collected/analyzed.
|
0 Participants
No data were collected/analyzed.
|
0 Participants
No data were collected/analyzed.
|
|
Sex: Female, Male
Male
|
0 Participants
No data were collected/analyzed.
|
0 Participants
No data were collected/analyzed.
|
0 Participants
No data were collected/analyzed.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
|
Race (NIH/OMB)
Asian
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
|
Race (NIH/OMB)
White
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
0 Participants
No data were collected/analyzed
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
3 participants
n=3 Participants
|
11 participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: No data were analyzed for this outcome because there were no participants data collected.
Weekly visual analog system (VAS) pain scores will be measured daily for four weeks. The VAS pain score is a measure of pain severity. It is measured on a scale from 0 to 10, with 10 being the worst pain the patient has experienced. No patients completed full enrollment so no data was analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 weeksPopulation: No data were analyzed for this outcome because there were no participants data collected
The foot function index (FFI) is a questionnaire that measures foot pain and disability. It is self-administered and consists of 23 items divided into 3 subscales (pain, disability, and activity limitation). The pain subcategory consists of 9 questions (scored out of 90) and is a measure of pain in different situations, such as walking with shoes versus barefoot. The disability subcategory consists of 9 questions (scored out of 90) and measures functional activities, such as difficulty walking upstairs. The activity limitation subcategory consists of 5 questions (scored out of 50) and measures limitations caused by the foot problem. All three subcategories are summed together to get a final number, with higher numbers indicating worse pain.
Outcome measures
Outcome data not reported
Adverse Events
Mg-CBDa Cream
Placebo Cream
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place