Plaque Psoriasis
Conditions
Brief summary
The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.
Interventions
DRUGDFD01 Spray
DRUGComp01 Lotion
Sponsors
Prosoft Clinical
Primus Pharmaceuticals
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
1. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis. 2. Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin, axillae and other intertriginous areas. 3. Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit 4. Subjects whose results from the screening 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
1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. 2. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state. 3. 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. 4. 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) 5. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene)2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. 6. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed. 7. Subjects who have an abnormal sleep schedule or work at night. 8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors. 9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Subjects With HPA Axis Suppression | Day 15 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DFD01 Spray Group 1 DFD01 Spray, bid, 28 days
DFD01 Spray | 27 |
| Comp01 Lotion Comp01 Lotion, bid, 14 days
Comp01 Lotion | 22 |
| DFD01 Spray Group 2 DFD01 Spray, bid, 14 days
DFD01 Spray | 25 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Subject moved | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Comp01 Lotion | Total | DFD01 Spray Group 1 | DFD01 Spray Group 2 |
|---|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 11.32 | 46.7 years STANDARD_DEVIATION 11.55 | 46.8 years STANDARD_DEVIATION 9.99 | 47.6 years STANDARD_DEVIATION 13.71 |
| Investigator's Global Assessment (IGA) IGA 3 (Moderate) | 21 Participants | 63 Participants | 20 Participants | 22 Participants |
| Investigator's Global Assessment (IGA) IGA 4 (Severe/Very Severe) | 1 Participants | 11 Participants | 7 Participants | 3 Participants |
| Normal Adrenal Corticotropic Hormone (ACTH) test | 22 Participants | 74 Participants | 27 Participants | 25 Participants |
| Percent Body Surface Area (BSA) involved | 26.8 Percent BSA affected STANDARD_DEVIATION 6.32 | 27.4 Percent BSA affected STANDARD_DEVIATION 8.9 | 26.5 Percent BSA affected STANDARD_DEVIATION 8.61 | 29.0 Percent BSA affected STANDARD_DEVIATION 11.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 64 Participants | 24 Participants | 20 Participants |
| Region of Enrollment United States | 22 Participants | 74 Participants | 27 Participants | 25 Participants |
| Sex: Female, Male Female | 6 Participants | 21 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 16 Participants | 53 Participants | 21 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 27 | 6 / 22 | 8 / 25 |
| serious Total, serious adverse events | 0 / 27 | 0 / 22 | 0 / 25 |
Outcome results
Primary
The Number of Subjects With HPA Axis Suppression
Time frame: Day 15
Population: Three subjects in the 28 day DFD01 Treatment Group, three subjects in the 14 day Comp01 Treatment Group, and one subject in the 14 day DFD01 Treatment Group did not have ACTH stimulation test results.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DFD01 Spray Group 1 | The Number of Subjects With HPA Axis Suppression | 0 Participants |
| Comp01 Lotion | The Number of Subjects With HPA Axis Suppression | 5 Participants |
| DFD01 Spray Group 2 | The Number of Subjects With HPA Axis Suppression | 5 Participants |