Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream when applied twice daily for 15 days.
Detailed description
This was a 15-day, randomized, multicenter, comparator-controlled, open-label study. Approximately 50 subjects with moderate to severe plaque psoriasis were to be randomized to treatment with DFD-06 Cream or clobetasol propionate cream in a 1:1 ratio. Study products were applied twice daily for 15 days to all affected areas on the body excluding face, scalp, groin, axillae, and other intertriginous areas. Subject visits were scheduled at Screening, Baseline (Day 1), Day 8, Day 15, and Day 43 (if needed to confirm recovery). Clinical determinations of disease severity were conducted using the Investigator's Global Assessment (IGA) for overall severity at each visit.
Interventions
DRUGDFD06 Cream
DRUGClobetasol Propionate Cream 0.05%
Sponsors
Promius Pharma, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis. Subjects with psoriasis involving 20 to 50% Body Surface Area (BSA), not including the face, scalp, groin, axillae and other intertriginous areas. Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit Subjects whose results from the screening Adrenocorticotropic hormone (ACTH) stimulation test are considered normal (cortisol level \>18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA function or adrenal response
Exclusion criteria
Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state. Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit. Use within 60 days prior to the baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) psoralen and ultraviolet A (PUVA) therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) ultraviolet B (UVB) therapy. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed. Subjects who have an abnormal sleep schedule or work at night. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects With HPA Axis Suppression. | Day 15 | HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test) |
Countries
United States
Participant flow
Pre-assignment details
Washout was needed at Screening Visit if prohibited therapies were in use. The screening adrenocorticotropic hormone (ACTH) stimulation test was conducted at least 14 days and no more than 28 days prior to the Baseline Visit.
Participants by arm
| Arm | Count |
|---|---|
| DFD06 DFD06 Active | 24 |
| Comp01 Comp01 Comparator | 22 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | DFD06 | Comp01 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 22 Participants | 45 Participants |
| Age, Continuous | 43.5 years STANDARD_DEVIATION 14.5 | 50.9 years STANDARD_DEVIATION 11.2 | 47.0 years STANDARD_DEVIATION 13.4 |
| Body Surface Area (BSA) affected by psoriasis | 26.5 cm^2 STANDARD_DEVIATION 8.6 | 27.0 cm^2 STANDARD_DEVIATION 8.3 | 26.8 cm^2 STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 13 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 19 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 | 0 Participants | 0 Participants | 0 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 | 24 Participants | 22 Participants | 46 Participants |
| Region of Enrollment United States | 24 participants | 22 participants | 46 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 17 Participants | 14 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 24 |
| other Total, other adverse events | 11 / 22 | 5 / 24 |
| serious Total, serious adverse events | 0 / 22 | 1 / 24 |
Outcome results
Primary
The Percentage of Subjects With HPA Axis Suppression.
HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
Time frame: Day 15
Population: All summaries and analyses were performed on the safety population. All subjects who received at least one confirmed dose of study product and provided any post-baseline safety information were included in the safety population. No imputation was made for missing safety data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Cream, 0.05% | The Percentage of Subjects With HPA Axis Suppression. | 36.4 percentage of participants |
| DFD06 Cream | The Percentage of Subjects With HPA Axis Suppression. | 12.5 percentage of participants |
Comparison: Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.p-value: 0.086ANOVA