Dermatitis, Atopic
Conditions
Brief summary
this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.
Detailed description
The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis. The secondary objectives are to evaluate to evaluate adverse event (AE) profiles of DSXS administered to patients with moderate to severe atopic dermatitis.
Interventions
DRUGDSXS
Active treatment
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a definite clinical diagnosis of stable atopic dermatitis
Exclusion criteria
* Patient is under the age of 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HPA Axis Suppression | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSXS Topical Product Cohort 1 treatment with DSXS twice daily for 28 days in patients age 18 years and older
DSXS: Active treatment | 19 |
| DSXS Topical Product Cohort 2 treatment with DSXS twice daily for 28 days in patients age 12-17 years of age
DSXS: Active treatment | 4 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Enrolled In Error | 1 | 0 |
Baseline characteristics
| Characteristic | DSXS Topical Product Cohort 2 | DSXS Topical Product Cohort 1 | Total |
|---|---|---|---|
| Age, Continuous | 15.25 years STANDARD_DEVIATION 2.36 | 43.32 years STANDARD_DEVIATION 11.18 | 38.43 years STANDARD_DEVIATION 14.87 |
| Baseline IGA Almost Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA Mild Disease | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA Moderate Disease | 2 Participants | 17 Participants | 19 Participants |
| Baseline IGA Severe Disease | 2 Participants | 2 Participants | 4 Participants |
| Baseline Total BSA | 1.78 meters squared STANDARD_DEVIATION 0.31 | 2.03 meters squared STANDARD_DEVIATION 0.29 | 1.98 meters squared STANDARD_DEVIATION 0.3 |
| Eczema Area and Severity Index (EASI) Score | 28.50 units on a scale STANDARD_DEVIATION 19.91 | 19.74 units on a scale STANDARD_DEVIATION 9.08 | 21.26 units on a scale STANDARD_DEVIATION 11.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 13 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 14 Participants | 17 Participants |
| Sex: Female, Male Female | 2 Participants | 10 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 9 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 4 |
| other Total, other adverse events | 4 / 19 | 0 / 4 |
| serious Total, serious adverse events | 0 / 19 | 0 / 4 |
Outcome results
Primary
Number of Participants With HPA Axis Suppression
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.
Time frame: 28 days.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSXS Topical Product Cohort 1 | Number of Participants With HPA Axis Suppression | Yes | 3 Participants |
| DSXS Topical Product Cohort 1 | Number of Participants With HPA Axis Suppression | No | 16 Participants |
| DSXS Topical Product Cohort 2 | Number of Participants With HPA Axis Suppression | Yes | 1 Participants |
| DSXS Topical Product Cohort 2 | Number of Participants With HPA Axis Suppression | No | 3 Participants |