Trial Outcomes & Findings for Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis (NCT NCT02595073)
NCT ID: NCT02595073
Last Updated: 2018-12-07
Results Overview
Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear \[0\] or almost clear \[1\]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
124 participants
Primary outcome timeframe
28 days
Results posted on
2018-12-07
Participant Flow
Participant milestones
| Measure |
DSXS Topical Product
Desoximetasone (DSXS) Active treatment
DSXS: Active treatment
|
Placebo Topical Product
Placebo treatment
Placebo: Placebo treatment
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
63
|
|
Overall Study
COMPLETED
|
59
|
62
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
DSXS Topical Product
Desoximetasone (DSXS) Active treatment
DSXS: Active treatment
|
Placebo Topical Product
Placebo treatment
Placebo: Placebo treatment
|
|---|---|---|
|
Overall Study
Progressive Disease
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
DSXS Topical Product
n=61 Participants
DSXS Active treatment
DSXS: Active treatment
|
Placebo Topical Product
n=63 Participants
Placebo treatment
Placebo: Placebo treatment
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 18.8 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 18.5 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 18.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 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
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
99 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Baseline Total Body Surface Area (BSA)
|
1.8 meters squared
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.9 meters squared
STANDARD_DEVIATION 0.3 • n=7 Participants
|
1.9 meters squared
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
%BSA Affected with Atopic Dermatitis (AD)
|
23.4 percent
STANDARD_DEVIATION 7.5 • n=5 Participants
|
23.3 percent
STANDARD_DEVIATION 10.1 • n=7 Participants
|
23.4 percent
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Baseline Investigator Global Assessment (IGA) Score
Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator Global Assessment (IGA) Score
Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator Global Assessment (IGA) Score
Mild Disease
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator Global Assessment (IGA) Score
Moderate Disease
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Baseline Investigator Global Assessment (IGA) Score
Severe Disease
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Eczema Area and Severity Index (EASI) Score
|
18.8 units on a scale
STANDARD_DEVIATION 4.4 • n=5 Participants
|
18.6 units on a scale
STANDARD_DEVIATION 3.6 • n=7 Participants
|
18.7 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysClinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear \[0\] or almost clear \[1\]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema
Outcome measures
| Measure |
DSXS Topical Product
n=61 Participants
DSXS Active treatment
DSXS: Active treatment
|
Placebo Topical Product
n=63 Participants
Placebo treatment
Placebo: Placebo treatment
|
|---|---|---|
|
The Number of Patients in Each Treatment Group That Have Clinical Success
|
21 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 28 daysThe change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2)
Outcome measures
| Measure |
DSXS Topical Product
n=61 Participants
DSXS Active treatment
DSXS: Active treatment
|
Placebo Topical Product
n=63 Participants
Placebo treatment
Placebo: Placebo treatment
|
|---|---|---|
|
Change From Baseline in %BSA Affected at Day 28 ± 2
|
-13.81 percentage of BSA
Standard Error 0.99
|
-13.24 percentage of BSA
Standard Error 0.96
|
Adverse Events
DSXS Topical Product
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Topical Product
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DSXS Topical Product
n=61 participants at risk
DSXS Active treatment
DSXS: Active treatment
|
Placebo Topical Product
n=63 participants at risk
Placebo treatment
Placebo: Placebo treatment
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/61 • Number of events 1 • 1 year, 4 months
|
0.00%
0/63 • 1 year, 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/61 • Number of events 1 • 1 year, 4 months
|
3.2%
2/63 • Number of events 2 • 1 year, 4 months
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61 • Number of events 1 • 1 year, 4 months
|
0.00%
0/63 • 1 year, 4 months
|
|
General disorders
Application site pain
|
1.6%
1/61 • Number of events 1 • 1 year, 4 months
|
1.6%
1/63 • Number of events 1 • 1 year, 4 months
|
|
General disorders
Application site pruritus
|
1.6%
1/61 • Number of events 1 • 1 year, 4 months
|
0.00%
0/63 • 1 year, 4 months
|
|
General disorders
Pyrexia
|
1.6%
1/61 • Number of events 1 • 1 year, 4 months
|
0.00%
0/63 • 1 year, 4 months
|
|
Infections and infestations
Herpes zoster
|
1.6%
1/61 • Number of events 1 • 1 year, 4 months
|
0.00%
0/63 • 1 year, 4 months
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
2/61 • Number of events 2 • 1 year, 4 months
|
4.8%
3/63 • Number of events 3 • 1 year, 4 months
|
|
Infections and infestations
Oral herpes
|
1.6%
1/61 • Number of events 1 • 1 year, 4 months
|
1.6%
1/63 • Number of events 1 • 1 year, 4 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/61 • 1 year, 4 months
|
1.6%
1/63 • Number of events 1 • 1 year, 4 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/61 • 1 year, 4 months
|
1.6%
1/63 • Number of events 1 • 1 year, 4 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.6%
1/61 • Number of events 1 • 1 year, 4 months
|
0.00%
0/63 • 1 year, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/61 • 1 year, 4 months
|
1.6%
1/63 • Number of events 1 • 1 year, 4 months
|
|
Nervous system disorders
Dizziness
|
1.6%
1/61 • Number of events 1 • 1 year, 4 months
|
0.00%
0/63 • 1 year, 4 months
|
|
Nervous system disorders
Headache
|
4.9%
3/61 • Number of events 6 • 1 year, 4 months
|
3.2%
2/63 • Number of events 2 • 1 year, 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/61 • 1 year, 4 months
|
3.2%
2/63 • Number of events 2 • 1 year, 4 months
|
|
Vascular disorders
Spider vein
|
0.00%
0/61 • 1 year, 4 months
|
1.6%
1/63 • Number of events 1 • 1 year, 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place