Psoriasis
Conditions
Brief summary
This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.
Detailed description
This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.
Interventions
DRUGDFD06 Cream
Twice daily topical application for 14 days.
DRUGVehicle Cream
Twice daily topical application for 14 days.
Sponsors
Promius Pharma, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study. 2. Subject must be at least 18 years of age. 3. Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis. 4. Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas. 5. Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit. 6. Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment. 7. Subject must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
Exclusion criteria
1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. 2. Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis). 3. Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters. 4. History of psoriasis unresponsive to biological or topical treatments. 5. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state. 6. Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept). 7. 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. 8. Use within 60 days prior to the Baseline Visit of: 1) systemic or topical immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin). 9. Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed. 10. Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids. 11. Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Treatment Success at Day 15 | Day 15 Visit | The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Body Surface Area at Day 15 | Baseline and Day 15 | Percent change from baseline in body surface area affected by psoriasis at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets. |
| Percent of Subjects With Treatment Success at Day 8 Visit | Baseline and Day 8 | Percent of subjects with treatment success at Day 8 Visit defined as an IGA of 0 or 1 with at least a 2 grade reduction from baseline. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DFD-06 Cream Participants applied DFD-06 Cream twice daily for 14 days. | 178 |
| Vehicle Cream Participants received Vehicle Cream and was applied twice daily for 14 days. | 89 |
| Total | 267 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Vehicle Cream | DFD-06 Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 27 Participants | 41 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants | 151 Participants | 226 Participants |
| Age, Continuous | 50.6 years STANDARD_DEVIATION 15.93 | 49.5 years STANDARD_DEVIATION 13.59 | 49.8 years STANDARD_DEVIATION 14.4 |
| Region of Enrollment United States | 89 Participants | 178 Participants | 267 Participants |
| Sex: Female, Male Female | 45 Participants | 78 Participants | 123 Participants |
| Sex: Female, Male Male | 44 Participants | 100 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 178 | 0 / 89 |
| other Total, other adverse events | 24 / 178 | 17 / 89 |
| serious Total, serious adverse events | 1 / 178 | 0 / 89 |
Outcome results
Primary
Percentage of Subjects With Treatment Success at Day 15
The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Time frame: Day 15 Visit
Population: Intention to treat population defined as all subjects who were randomized and dispensed medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DFD-06 Cream | Percentage of Subjects With Treatment Success at Day 15 | 30.2 percentage of participants |
| Vehicle Cream | Percentage of Subjects With Treatment Success at Day 15 | 9.0 percentage of participants |
Secondary
Percent Change From Baseline in Body Surface Area at Day 15
Percent change from baseline in body surface area affected by psoriasis at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Time frame: Baseline and Day 15
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DFD-06 Cream | Percent Change From Baseline in Body Surface Area at Day 15 | -28.9 percentage change in body surface area | Standard Deviation 34 |
| Vehicle Cream | Percent Change From Baseline in Body Surface Area at Day 15 | -6.1 percentage change in body surface area | Standard Deviation 32.67 |
Secondary
Percent of Subjects With Treatment Success at Day 8 Visit
Percent of subjects with treatment success at Day 8 Visit defined as an IGA of 0 or 1 with at least a 2 grade reduction from baseline. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Time frame: Baseline and Day 8
Population: Intention to treat population defined as all subjects who were randomized and dispensed medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DFD-06 Cream | Percent of Subjects With Treatment Success at Day 8 Visit | 15.7 percentage of subject |
| Vehicle Cream | Percent of Subjects With Treatment Success at Day 8 Visit | 5.6 percentage of subject |