Trial Outcomes & Findings for A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers (NCT NCT03473184)
NCT ID: NCT03473184
Last Updated: 2020-02-10
Results Overview
The mean of the total irritation scores 24 and 48 hours post the site irradiation procedure. ( i.e. Day 3 and 4) Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score= 0; Maximum score = 5; higher score = worse outcome.
COMPLETED
PHASE1
34 participants
Days 3 and 4 (24 and 48 hours post site irradiation procedure)
2020-02-10
Participant Flow
Unit of analysis: skin sites
Participant milestones
| Measure |
Single Cohort (Healthy Volunteers)
Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.
|
|---|---|
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Overall Study
STARTED
|
34 170
|
|
Overall Study
Diacerein 1% Ointment Irradiated
|
34 34
|
|
Overall Study
Vehicle Ointment Irradiated
|
34 34
|
|
Overall Study
Diacerein 1% Ointment Non-irradiated
|
34 34
|
|
Overall Study
Vehicle Ointment Non-irradiated
|
34 34
|
|
Overall Study
Untreated Irradiated
|
34 34
|
|
Overall Study
COMPLETED
|
34 170
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Single Cohort (Healthy Volunteers)
n=34 Participants
Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.
|
|---|---|
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Age, Continuous
|
55.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 3 and 4 (24 and 48 hours post site irradiation procedure)Population: 5 skin sites on each of 34 participants for a total of 170 skin sites evaluated.
The mean of the total irritation scores 24 and 48 hours post the site irradiation procedure. ( i.e. Day 3 and 4) Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score= 0; Maximum score = 5; higher score = worse outcome.
Outcome measures
| Measure |
Single Cohort (Healthy Volunteer)
n=170 skin sites
Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.
|
|---|---|
|
Observed Phototoxicity
Diacerein 1% ointment irradiated
|
0.15 Score on a scale
Standard Deviation 0.31
|
|
Observed Phototoxicity
Vehicle ointment irradiated
|
0.15 Score on a scale
Standard Deviation 0.31
|
|
Observed Phototoxicity
Diacerein 1% ointment non-irradiated
|
0.00 Score on a scale
Standard Deviation 0.00
|
|
Observed Phototoxicity
Vehicle ointment non-irradiated
|
0.00 Score on a scale
Standard Deviation 0.00
|
|
Observed Phototoxicity
Untreated irradiated
|
0.15 Score on a scale
Standard Deviation 0.31
|
Adverse Events
Single Cohort (Healthy Volunteers)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mary Spellman; Chief Medical Officer
Castle Creek Pharmaceuticals, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place