Atopic Dermatitis
Conditions
Brief summary
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS in Patients with Atopic Dermatitis
Detailed description
To evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe atopic dermatitis.
Interventions
DRUGDSXS topical
topical treatment
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Parent/legal guardian has signed informed consent form, which meets all criteria of current FDA regulations.
Exclusion criteria
* Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients in the Study With HPA Axis Suppression | 29 Days | Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSXS Topical Cohort 1 active treatment
DSXS topical: topical treatment | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | HPA Suppress | 2 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | DSXS Topical Cohort 1 |
|---|---|
| Age, Continuous | 14.36 years STANDARD_DEVIATION 1.64 |
| Baseline IGA Clear | 0 Participants |
| Baseline IGA Mild | 0 Participants |
| Baseline IGA Minimal | 0 Participants |
| Baseline IGA Moderate Disease | 17 Participants |
| Baseline IGA Severe Disease | 11 Participants |
| Baseline Total BSA | 1.61 meters squared STANDARD_DEVIATION 0.24 |
| Eczema Area and Severity Index (EASI) Score | 17.64 units on a scale STANDARD_DEVIATION 2.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 3 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
The Number of Patients in the Study With HPA Axis Suppression
Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator
Time frame: 29 Days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSXS Topical Cohort 1 | The Number of Patients in the Study With HPA Axis Suppression | Yes | 8 Participants |
| DSXS Topical Cohort 1 | The Number of Patients in the Study With HPA Axis Suppression | No | 9 Participants |