Plaque Psoriasis
Conditions
Keywords
122-0551, steroid, HPA
Brief summary
Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of the formulation.
Interventions
DRUG122-0551
Applied twice daily for 2 weeks
Sponsors
Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has a clinical diagnosis of stable plaque psoriasis
Exclusion criteria
* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis * Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis * Subject has used any phototherapy, photo-chemotherapy or systemic psoriasis therapy within 30 days prior to initiation of treatment * Subject has used systemic corticosteroids or topical, inhaled, intranasal corticosteroids within 30 days and 14 days, respectively, prior to study screening * Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to initiation of treatment * Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to initiation of treatment * Subject has used emollients/moisturizers on areas to be treated within one day prior to initiation of treatment * Subject is currently using lithium or Plaquenil (hydroxychloroquine) * Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has not been stabilized * Subject is pregnant, nursing or planning a pregnancy during the study period * Subject is currently enrolled in an investigational drug, biologic or device study * Subject has received an investigational drug, biologic or an investigational device within 30 days prior to study start * Subject has been previously enrolled in this study and treated with the test article * Subject has an irregular sleep schedule or works night shifts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypothalamic-Pituitary-Adrenal (HPA) Axis Response | Day 15 | HPA axis response to stimulation by cosyntropin, dichotomized to normal and abnormal. Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: April 2012 to March 2013 The location of clinical sites included private dermatology clinics and clinical research centers.
Pre-assignment details
All subjects who met the entry criteria were enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| 122-0551 122-0551: Applied twice daily for 2 weeks | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | 122-0551 |
|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 11.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants |
| Race/Ethnicity, Customized Race Islander | 1 Participants |
| Race/Ethnicity, Customized Race White | 21 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 8 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Hypothalamic-Pituitary-Adrenal (HPA) Axis Response
HPA axis response to stimulation by cosyntropin, dichotomized to normal and abnormal. Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.
Time frame: Day 15
Population: Analysis shown is based on the ITT population, defined as all enrolled participants who applied at least one dose of the test article and returned for at least one post-Baseline visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 122-0551 | Hypothalamic-Pituitary-Adrenal (HPA) Axis Response | Normal | 19 Participants |
| 122-0551 | Hypothalamic-Pituitary-Adrenal (HPA) Axis Response | Abnormal | 6 Participants |