Plaque Psoriasis
Conditions
Brief summary
The purpose of this study is to assess clinical response and patient satisfaction when DFD-01 is used topically twice a day for moderate plaque psoriasis.
Detailed description
This multicenter, multi-dose, open-label study was designed to assess clinical response and patient-reported satisfaction after dosing with DFD-01 twice daily for 28 days. The product was approved for the treatment of mild to moderate plaque psoriasis by the FDA on February 5, 2016 before the first patient was enrolled. Forty five (45) adult males and females, 18 years of age and older with a clinical diagnosis of moderate plaque psoriasis who met inclusion/exclusion criteria were randomized at the Baseline Visit. Each site attempted to enroll 50% of the patients with 3% to 10% body surface area (BSA) involved and 50% of the patients with \> 10% BSA involved. The initial dose of study product was self-administered by the patient and supervised by clinic staff during the Baseline Visit. Patients continued to apply the study product to all affected areas (avoiding the face, scalp, groin, axillae or other intertriginous areas) twice daily (approximately 12 hours apart) for 28 days. Patients visited the clinic for a total of up to five scheduled visits: * Screening (Day -60 to 1)\* * Baseline (Day 1) * Interim Visit (Day 8 ± 2) * Interim Visit (Day 14 ± 3) * End of Study (Day 29 ± 3)
Interventions
DRUGDFD-01 (betamethasone dipropionate) Spray, 0.05%
DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
Sponsors
Prosoft Clinical
Primus Pharmaceuticals
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
1. Patient understands the study procedures and agrees to participate by giving written informed consent. Patients must be willing to authorize use and disclosure of protected health information collected for the study. 2. Patient must be at least 18 years of age. 3. Patient must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis. 4. At least 3% Body Surface Area involved, not including the face, scalp, groin, axillae and other intertriginous areas. 5. Female patients of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the patient become sexually active. A female is considered of childbearing potential unless she is: 1. Postmenopausal for at least 12 months prior to study product administration; 2. Without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal ligation) for at least 6 months prior to study product administration. Reliable methods of contraception are: 1. Hormonal methods or intrauterine device in use \> 90 days prior to study product administration; or 2. Barrier methods plus spermicide in use at least 14 days prior to study product administration. 3. Partner has had a vasectomy at least 3 months previous to study product administration. 4. Essure® that has been in place for at least 3 months before the screening visit with radiograph confirmation of fallopian tube blockage. Exception: Sexually inactive female patients of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study. An abstinent female must agree that if she becomes sexually active during the study she will use an acceptable form of contraception. All women must complete a urine pregnancy test at the Baseline Visit (Day 1) and the test result must be negative to be eligible for enrollment. 6. Patient 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 (temperature, blood pressure and pulse). 7. Patient is physically able to apply study product to all affected areas or can obtain help.
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, pigmented lesions, tattoos or sunburn that could interfere with the rating of efficacy parameters. 4. History of psoriasis unresponsive to topical treatments. 5. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state. 6. Ongoing infection (including viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds) or evidence of chronic infectious disease, history of or current system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation in the study. 7. Use within 180 days before Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept). 8. Have received treatment for any type of cancer within 5 years of the Baseline Visit, except skin cancer and cervical cancer (in situ) that are allowed if at least 1 year before the Baseline Visit. 9. Use within 60 days before 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). 10. Use within 30 days before the Baseline Visit of: 1) systemic corticosteroids, 2) Ultraviolet light therapy, or 3) systemic anti-inflammatory agents\* (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine). \* Over-the-counter strength non-steroidal anti-inflammatory drugs used for transitional and common aches are permitted during the study. 11. Use within 14 days before 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. 12. History of unresolved or current hypothalamic-pituitary-adrenal suppression or significant endocrine disorder (Cushing's disease or Addison's disease) or uncontrolled diabetes. 13. Patients who have participated in a study of an investigational drug 30 days before the Baseline Visit. 14. Patients unable to comply with study requirements. 15. Female patients who are pregnant (or planning to become pregnant) or breast-feeding. 16. History of drug or alcohol abuse within the last year. 17. Planned use of a tanning bed during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Investigator's Global Assessment Grade | Change from Baseline to Day 14. | The mean change in the IGA score from baseline to Day 14 was assessed. IGA score is a static assessment of disease severity and is based on overall severity of signs at each visit. It's a 4-point scale where '0' is absent disease and '4' is 'Severe/Very Severe' disease. A lower score at the end of the study compared to baseline (negative change), indicates an improvement in the disease condition. |
| Change in Percent Body Surface Area (BSA) Involved. | Change from Baseline to Day 14. | Change in the BSA of involvement with psoriasis from baseline to Day 14 was assessed. BSA was assessed at Baseline, Days 8, 14 and 29. |
| Change in Dermatology Life Quality Index (DLQI) | Change from Baseline to Day 14. | DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (i.e., negative change score) indicates improvement in the Quality of Life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DFD-01 (Betamethasone Dipropionate) Spray, 0.05% DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | DFD-01 (Betamethasone Dipropionate) Spray, 0.05% |
|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 16.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Percent Body Surface Area Involved | 11.9 Percentage of Body Surface Area STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 1 / 45 |
Outcome results
Primary
Change in Dermatology Life Quality Index (DLQI)
DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (i.e., negative change score) indicates improvement in the Quality of Life.
Time frame: Change from Baseline to Day 14.
Population: The ITT population included all subjects randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DFD-01 (Betamethasone Dipropionate) Spray, 0.05% | Change in Dermatology Life Quality Index (DLQI) | -6.6 units on a scale | Standard Deviation 6.72 |
Primary
Change in Investigator's Global Assessment Grade
The mean change in the IGA score from baseline to Day 14 was assessed. IGA score is a static assessment of disease severity and is based on overall severity of signs at each visit. It's a 4-point scale where '0' is absent disease and '4' is 'Severe/Very Severe' disease. A lower score at the end of the study compared to baseline (negative change), indicates an improvement in the disease condition.
Time frame: Change from Baseline to Day 14.
Population: The ITT population included all randomized patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DFD-01 (Betamethasone Dipropionate) Spray, 0.05% | Change in Investigator's Global Assessment Grade | -0.8 units on a scale | Standard Deviation 0.77 |
Primary
Change in Percent Body Surface Area (BSA) Involved.
Change in the BSA of involvement with psoriasis from baseline to Day 14 was assessed. BSA was assessed at Baseline, Days 8, 14 and 29.
Time frame: Change from Baseline to Day 14.
Population: The ITT population included all patients randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DFD-01 (Betamethasone Dipropionate) Spray, 0.05% | Change in Percent Body Surface Area (BSA) Involved. | -1.3 percentage of BSA | Standard Deviation 2.82 |