Psoriasis
Conditions
Brief summary
A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis
Detailed description
All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other body areas affected by plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla)
Interventions
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 scalp psoriasis. 3. IGA of mild or greater (scalp only) determined at screening 4. Scalp surface area of 30% or greater determined at screening 5. Able to give written informed consent prior to performance of any study related procedures. 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. \<30% scalp surface area 2. Scalp Investigator global assessment (IGA) clear or almost clear at time of screening 3. Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study. 4. Pregnant or breast feeding, or considering becoming pregnant during the study. 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. Use of ustekinumab and/or anti-IL-17 (interleukin 17) biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose. 8. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla). 9. Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline. 10. Patient received psoralen and Ultraviolet A, PUVA phototherapy within 4 weeks of Baseline. 11. Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (Scalp Only) | 16 weeks | Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from private practice dermatology
Pre-assignment details
Of the 21 patients screened for participation, 20 subjects were enrolled to receive Open Label Topicort Topical Spray
Participants by arm
| Arm | Count |
|---|---|
| Topicort Topical Spray Topicort Topical Spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Topicort Topical Spray |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 50 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 9 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Investigator Global Assessment (Scalp Only)
Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe)
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Topicort Topical Spray | Investigator Global Assessment (Scalp Only) | 1.59 score on a scale |