Trial Outcomes & Findings for An Open Label, Safety Study to Assess the Potential for Adrenal Suppression. (NCT NCT02932891)
NCT ID: NCT02932891
Last Updated: 2018-12-07
Results Overview
Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
29 Days
Results posted on
2018-12-07
Participant Flow
Participant milestones
| Measure |
DSXS Topical Cohort 1
active treatment
DSXS topical: topical treatment
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
DSXS Topical Cohort 1
active treatment
DSXS topical: topical treatment
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
HPA Suppress
|
2
|
Baseline Characteristics
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.
Baseline characteristics by cohort
| Measure |
DSXS Topical Cohort 1
n=28 Participants
active treatment
DSXS topical: topical treatment
|
|---|---|
|
Age, Continuous
|
14.36 years
STANDARD_DEVIATION 1.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 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
|
|
Baseline Total BSA
|
1.61 meters squared
STANDARD_DEVIATION 0.24 • n=5 Participants
|
|
Baseline IGA
Clear
|
0 Participants
n=5 Participants
|
|
Baseline IGA
Minimal
|
0 Participants
n=5 Participants
|
|
Baseline IGA
Mild
|
0 Participants
n=5 Participants
|
|
Baseline IGA
Moderate Disease
|
17 Participants
n=5 Participants
|
|
Baseline IGA
Severe Disease
|
11 Participants
n=5 Participants
|
|
Eczema Area and Severity Index (EASI) Score
|
17.64 units on a scale
STANDARD_DEVIATION 2.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: 29 DaysHypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator
Outcome measures
| Measure |
DSXS Topical Cohort 1
n=17 Participants
active treatment
DSXS topical: topical treatment
|
|---|---|
|
The Number of Patients in the Study With HPA Axis Suppression
Yes
|
8 Participants
|
|
The Number of Patients in the Study With HPA Axis Suppression
No
|
9 Participants
|
Adverse Events
DSXS Topical Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DSXS Topical Cohort 1
n=28 participants at risk
active treatment
DSXS topical: topical treatment
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.6%
1/28 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.6%
1/28 • Number of events 1 • 8 months
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 2 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.6%
1/28 • Number of events 1 • 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place