Trial Outcomes & Findings for Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis (NCT NCT02595008)
NCT ID: NCT02595008
Last Updated: 2018-12-07
Results Overview
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
28 days.
Results posted on
2018-12-07
Participant Flow
Participant milestones
| Measure |
DSXS Topical Product Cohort 1
treatment with DSXS twice daily for 28 days in patients age 18 years and older
DSXS: Active treatment
|
DSXS Topical Product Cohort 2
treatment with DSXS twice daily for 28 days in patients age 12-17 years of age
DSXS: Active treatment
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
4
|
|
Overall Study
COMPLETED
|
19
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
DSXS Topical Product Cohort 1
treatment with DSXS twice daily for 28 days in patients age 18 years and older
DSXS: Active treatment
|
DSXS Topical Product Cohort 2
treatment with DSXS twice daily for 28 days in patients age 12-17 years of age
DSXS: Active treatment
|
|---|---|---|
|
Overall Study
Enrolled In Error
|
1
|
0
|
Baseline Characteristics
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
DSXS Topical Product Cohort 1
n=19 Participants
treatment with DSXS twice daily for 28 days in patients age 18 years and older
DSXS: Active treatment
|
DSXS Topical Product Cohort 2
n=4 Participants
treatment with DSXS twice daily for 28 days in patients age 12-17 years of age
DSXS: Active treatment
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.32 years
STANDARD_DEVIATION 11.18 • n=99 Participants
|
15.25 years
STANDARD_DEVIATION 2.36 • n=107 Participants
|
38.43 years
STANDARD_DEVIATION 14.87 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Baseline Total BSA
|
2.03 meters squared
STANDARD_DEVIATION 0.29 • n=99 Participants
|
1.78 meters squared
STANDARD_DEVIATION 0.31 • n=107 Participants
|
1.98 meters squared
STANDARD_DEVIATION 0.30 • n=206 Participants
|
|
Baseline IGA
Clear
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Baseline IGA
Almost Clear
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Baseline IGA
Mild Disease
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Baseline IGA
Moderate Disease
|
17 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Baseline IGA
Severe Disease
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Eczema Area and Severity Index (EASI) Score
|
19.74 units on a scale
STANDARD_DEVIATION 9.08 • n=99 Participants
|
28.50 units on a scale
STANDARD_DEVIATION 19.91 • n=107 Participants
|
21.26 units on a scale
STANDARD_DEVIATION 11.53 • n=206 Participants
|
PRIMARY outcome
Timeframe: 28 days.Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.
Outcome measures
| Measure |
DSXS Topical Product Cohort 1
n=19 Participants
treatment with DSXS twice daily for 28 days in patients age 18 years and older
DSXS: Active treatment
|
DSXS Topical Product Cohort 2
n=4 Participants
treatment with DSXS twice daily for 28 days in patients age 12-17 years of age
DSXS: Active treatment
|
|---|---|---|
|
Number of Participants With HPA Axis Suppression
No
|
16 Participants
|
3 Participants
|
|
Number of Participants With HPA Axis Suppression
Yes
|
3 Participants
|
1 Participants
|
Adverse Events
DSXS Topical Product Cohort 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DSXS Topical Product 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
| Measure |
DSXS Topical Product Cohort 1
n=19 participants at risk
treatment with DSXS twice daily for 28 days in patients age 18 years and older
DSXS: Active treatment
|
DSXS Topical Product Cohort 2
n=4 participants at risk
treatment with DSXS twice daily for 28 days in patients age 12-17 years of age
DSXS: Active treatment
|
|---|---|---|
|
Investigations
ACTH stimulation test abnormal
|
15.8%
3/19 • Number of events 3 • 1 year, 6 months
|
0.00%
0/4 • 1 year, 6 months
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • 1 year, 6 months
|
0.00%
0/4 • 1 year, 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place