Plaque Psoriasis
Conditions
Brief summary
The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.
Detailed description
An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.
Interventions
DRUGTopicort® (desoximetasone) Topical Spray, 0.25%
Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
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 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative * Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp) * Physicians Global Assessment score of 3 or 4 at baseline
Exclusion criteria
* Has other dermatological conditions that may interfere with clinical assessments * Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results * History of an adverse reaction to Cortrosyn™ or similar test reagents * Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test | 28 days | A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria: * their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (\< basal + 7) * the post stimulation level is ≤ 18 mcg/100 ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | 28 days | The total number of subjects experiencing adverse events. |
| Cpre-ss | 28 Days | Concentration prior to dosing at steady state. |
Countries
United States
Participant flow
Recruitment details
The first patient enrolled in the study 23 January 2015. The last patient completed the study 22 November 2019. The Patients were enrolled in 3 cohorts. Cohort 1, 12 to 17 years and 11 months, Cohort 2, 6 year to 11 and 11 Months and Cohort 3, 2 years to 5 years and 11 months. In total 129 subjects were enrolled across 7 Investigator sites.
Pre-assignment details
Prior to the Protocol Amendment if a subject was found to have an abnormal adrenal function test after the baseline Cortisol Response test the subject was notified to discontinue the drug and follow up with the Investigator. After the protocol amendment a screening visit was added so that subjects with abnormal tests would not be randomized to study drug.
Participants by arm
| Arm | Count |
|---|---|
| Topicort® Topical Spray, 0.25% Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days
Topicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days | 129 |
| Total | 129 |
Baseline characteristics
| Characteristic | Topicort® Topical Spray, 0.25% |
|---|---|
| Age, Customized Cohort 1 - 12 to 17 years of age | 84 Participants |
| Age, Customized Cohort 2- 6 to 11 years of age | 35 Participants |
| Age, Customized Cohort 3 - 2 to 5 years of age | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 126 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hypothalamic-Pituitary-Adrenal (HPA) Axis Function Cohort 1 - 12 to 17 years of age | 60 Participants |
| Hypothalamic-Pituitary-Adrenal (HPA) Axis Function Cohort 2 - 6 to 11 years of age | 30 Participants |
| Hypothalamic-Pituitary-Adrenal (HPA) Axis Function Cohort 3 - 2 to 5 years of age | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 26 Participants |
| Race (NIH/OMB) White | 102 Participants |
| Region of Enrollment El Salvador | 26 participants |
| Region of Enrollment Panama | 27 participants |
| Region of Enrollment United States | 76 participants |
| Sex: Female, Male Cohort 1 -12 to 17 years of age Female | 35 Participants |
| Sex: Female, Male Cohort 1 -12 to 17 years of age Male | 49 Participants |
| Sex: Female, Male Cohort 2 - 6 to 11 years of age Female | 23 Participants |
| Sex: Female, Male Cohort 2 - 6 to 11 years of age Male | 12 Participants |
| Sex: Female, Male Cohort 3- 2 to 5 years of age Female | 4 Participants |
| Sex: Female, Male Cohort 3- 2 to 5 years of age Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 129 |
| other Total, other adverse events | 0 / 129 |
| serious Total, serious adverse events | 0 / 129 |
Outcome results
Primary
The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test
A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria: * their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (\< basal + 7) * the post stimulation level is ≤ 18 mcg/100 ml
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test | 21 Participants |
| Cohort 2 | The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test | 13 Participants |
| Cohort 3 | The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test | 2 Participants |
Secondary
Adverse Event
The total number of subjects experiencing adverse events.
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Adverse Event | 1 Participants |
Secondary
Cpre-ss
Concentration prior to dosing at steady state.
Time frame: 28 Days
Population: PK sampling from was taken from a subset of patients in cohorts 1 and 2
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Cpre-ss | 527.64 pg/mL | Geometric Coefficient of Variation 574.47 |
| Cohort 2 | Cpre-ss | 475.41 pg/mL | Geometric Coefficient of Variation 215.66 |