Trial Outcomes & Findings for A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris (NCT NCT03173547)
NCT ID: NCT03173547
Last Updated: 2021-08-10
Results Overview
Number of participants that show at least a 2 level improvement of overall severity of disease (as measured by IGA score) at 6 weeks. The IGA score is a static evaluation of the overall or "average" degree of severity of a participant's disease, taking into account all of the participant's scaling, erythema, and fissuring in the Treatment Area. IGA was assessed using the following 5-point scale: clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Day 43 (6 weeks)
Results posted on
2021-08-10
Participant Flow
Participant milestones
| Measure |
146-9251 Cream
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
146-9251 cream: 146-9251 cream contains an active drug and is applied topically.
|
Vehicle Cream
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
146-9251 Cream
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
146-9251 cream: 146-9251 cream contains an active drug and is applied topically.
|
Vehicle Cream
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris
Baseline characteristics by cohort
| Measure |
146-9251 Cream
n=40 Participants
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
146-9251 cream: 146-9251 cream contains an active drug and is applied topically.
|
Vehicle Cream
n=40 Participants
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 19.41 • n=99 Participants
|
51.4 years
STANDARD_DEVIATION 17.42 • n=107 Participants
|
53.1 years
STANDARD_DEVIATION 18.41 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Investigator's Global Assessment (IGA) Score
3-Moderate
|
30 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Investigator's Global Assessment (IGA) Score
4-Severe
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 43 (6 weeks)Population: ITT population.
Number of participants that show at least a 2 level improvement of overall severity of disease (as measured by IGA score) at 6 weeks. The IGA score is a static evaluation of the overall or "average" degree of severity of a participant's disease, taking into account all of the participant's scaling, erythema, and fissuring in the Treatment Area. IGA was assessed using the following 5-point scale: clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Outcome measures
| Measure |
146-9251 Cream
n=39 Participants
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
146-9251 cream: 146-9251 cream contains an active drug and is applied topically.
|
Vehicle Cream
n=39 Participants
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.
|
|---|---|---|
|
Treatment Success
|
21 Participants
|
28 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 through study completion, average 6 weeks, Day 43.Population: ITT population
AEs will be assessed by the investigator and the number of participants with any local and systemic AEs will be reported.
Outcome measures
| Measure |
146-9251 Cream
n=40 Participants
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
146-9251 cream: 146-9251 cream contains an active drug and is applied topically.
|
Vehicle Cream
n=40 Participants
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.
|
|---|---|---|
|
Adverse Events (AEs)
Number of Subjects with any AE
|
9 Participants
|
14 Participants
|
|
Adverse Events (AEs)
Number of Subjects without an AE
|
31 Participants
|
26 Participants
|
Adverse Events
146-9251 Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle Cream
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
146-9251 Cream
n=40 participants at risk
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
146-9251 cream: 146-9251 cream contains an active drug and is applied topically.
|
Vehicle Cream
n=40 participants at risk
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/40 • AEs were collected from study day 1 to end of study (week 6).
|
12.5%
5/40 • Number of events 5 • AEs were collected from study day 1 to end of study (week 6).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place