Psoriasis
Conditions
Brief summary
The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.
Interventions
Sponsors
Prosoft Clinical
Primus Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis. * Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas. * Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit
Exclusion criteria
* Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. * Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis). * Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters. * History of psoriasis unresponsive to topical treatments. * History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Success According to the Investigator Global Assessment (IGA) | Day 15 | IGA of clear or almost clear |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DFD01 Spray DFD01 Spray twice daily for 28 days
DFD01 Spray | 174 |
| Vehicle Spray Vehicle Spray twice daily for 28 days
Vehicle Spray | 87 |
| Comp01 Lotion Comp01 Lotion twice daily for 14 days
Comp01 Lotion | 90 |
| Vehicle Lotion Vehicle Lotion twice daily for 28 days
Vehicle Lotion | 43 |
| Total | 394 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 2 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 5 | 3 | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 | 0 |
| Overall Study | Worsening of condition | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | DFD01 Spray | Vehicle Spray | Comp01 Lotion | Vehicle Lotion | Total |
|---|---|---|---|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 14.54 | 50.2 years STANDARD_DEVIATION 14.12 | 51.0 years STANDARD_DEVIATION 12.75 | 51.6 years STANDARD_DEVIATION 12.67 | 50.0 years STANDARD_DEVIATION 13.85 |
| Region of Enrollment United States | 174 participants | 87 participants | 90 participants | 43 participants | 394 participants |
| Sex: Female, Male Female | 63 Participants | 36 Participants | 34 Participants | 19 Participants | 152 Participants |
| Sex: Female, Male Male | 111 Participants | 51 Participants | 56 Participants | 24 Participants | 242 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 23 / 173 | 15 / 87 | 19 / 90 | 20 / 43 |
| serious Total, serious adverse events | 0 / 173 | 1 / 87 | 2 / 90 | 0 / 43 |
Outcome results
Primary
Percentage of Participants With Success According to the Investigator Global Assessment (IGA)
IGA of clear or almost clear
Time frame: Day 15
Population: Efficacy was only done on DFD01 Spray and Vehicle Spray. Protocol specifically noted no efficacy would be done on comparator or its vehicle.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DFD01 Spray | Percentage of Participants With Success According to the Investigator Global Assessment (IGA) | 19.0 percentage of patients |
| Vehicle Spray | Percentage of Participants With Success According to the Investigator Global Assessment (IGA) | 2.3 percentage of patients |
p-value: <0.001Cochran-Mantel-Haenszel