Psoriasis
Conditions
Brief summary
A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks
Detailed description
A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks. Adult male and female subjects with moderate to severe chronic plaque psoriasis All patients will receive Topicort® BID for 4 weeks. After week 4 patients will receive Topicort® BID on two consecutive days a week for 12 weeks.
Interventions
open label Topicort spray
Sponsors
Sun Pharmaceutical Industries, Inc.
Psoriasis Treatment Center of Central New Jersey
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. Male or female adults ≥ 18 years of age. 2. Diagnosis of chronic plaque-type psoriasis. 3. Able to give written informed consent prior to performance of any study related procedures. 4. Treated with a biologic agent for a minimum of 24 weeks at baseline. 5. Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%. 6. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. 7. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.
Exclusion criteria
1. \>5% Body Surface Area 2. Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study. 3. Pregnant or breast feeding, or considering becoming pregnant during the study. 4. Malignancy or history of malignancy, except for: 1. treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas; 2. treated \[ie, cured\] malignancy with no evidence of recurrence within the previous 5 years. 5. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer). 6. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine). 7. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids). 8. Patient received UVB phototherapy within 2 weeks of Baseline. 9. Patient received PUVA phototherapy within 4 weeks of Baseline. 10. Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Severity | 16 weeks | Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Severity | 16 weeks | Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis |
| Dermatology Life Quality Index | 16 weeks | calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label Topicort topical spray
Topicort Topical Spray: open label Topicort spray applied twice daily for 4 weeks followed by twice daily BID on two consecutive days a week (e.g. Saturday and Sunday) for 12 weeks. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Open Label |
|---|---|
| Age, Continuous | 53.33 years STANDARD_DEVIATION 7.92 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Psoriasis Severity
Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label | Psoriasis Severity | 4.25 units on a scale | Standard Deviation 5.71 |
Secondary
Dermatology Life Quality Index
calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label | Dermatology Life Quality Index | 3.65 units on a scale | Standard Deviation 4.08 |
Secondary
Psoriasis Severity
Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label | Psoriasis Severity | 1.65 units on a scale | Standard Deviation 0.89 |
Secondary
Psoriasis Severity
Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label | Psoriasis Severity | 2.05 percentage of BSA | Standard Deviation 2.28 |