Trial Outcomes & Findings for An Open Label, Safety Study to Assess the Potential for Adrenal Suppression (NCT NCT02932878)
NCT ID: NCT02932878
Last Updated: 2018-12-06
Results Overview
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
28 Days
Results posted on
2018-12-06
Participant Flow
Participant milestones
| Measure |
DSXS Topical Cohort 1
administered twice daily for 28 days in patients age 12-18 years of age
DSXS topical: topical treatment
|
DSXS Topical Cohort 2
administered twice daily for 28 days in patients age 6-11 years or age
DSXS topical: topical treatment
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
1
|
|
Overall Study
COMPLETED
|
13
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
DSXS Topical Cohort 1
administered twice daily for 28 days in patients age 12-18 years of age
DSXS topical: topical treatment
|
DSXS Topical Cohort 2
administered twice daily for 28 days in patients age 6-11 years or age
DSXS topical: topical treatment
|
|---|---|---|
|
Overall Study
Due to Lab Results
|
2
|
1
|
Baseline Characteristics
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression
Baseline characteristics by cohort
| Measure |
DSXS Topical Cohort 1
n=15 Participants
administered twice daily for 28 days in patients age 12-18 years of age
DSXS topical: topical treatment
|
DSXS Topical Cohort 2
n=1 Participants
administered twice daily for 28 days in patients age 6-11 years or age
DSXS topical: topical treatment
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.13 years
STANDARD_DEVIATION 1.88 • n=5 Participants
|
8.00 years
n=7 Participants
|
14.69 years
STANDARD_DEVIATION 2.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Total BSA
|
1.86 meters squared
STANDARD_DEVIATION 0.35 • n=5 Participants
|
1.31 meters squared
n=7 Participants
|
1.83 meters squared
STANDARD_DEVIATION 0.37 • n=5 Participants
|
|
Baseline IGA
Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline IGA
Minimal
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline IGA
Mild
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Baseline IGA
Moderate
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Baseline IGA
Severe
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: The one patient in Cohort 2 did not qualify for evaluation of HPA axis suppression.
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin
Outcome measures
| Measure |
DSXS Topical Cohort 1
n=11 Participants
administered twice daily for 28 days in patients age 12-18 years of age
DSXS topical: topical treatment
|
DSXS Topical Cohort 2
administered twice daily for 28 days in patients age 6-11 years or age
DSXS topical: topical treatment
|
|---|---|---|
|
Proportion of Patients in the Study With HPA Axis Suppression
Yes
|
1 Participants
|
0 Participants
|
|
Proportion of Patients in the Study With HPA Axis Suppression
No
|
10 Participants
|
0 Participants
|
Adverse Events
DSXS Topical Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DSXS Topical Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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