Psoriasis
Conditions
Brief summary
Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.
Detailed description
A two-phase, single center, observational study of 25 subjects to assess 4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QD on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks
Interventions
Topical foam
Sponsors
LEO Pharma
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. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer). 5. 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). 6. 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). 7. Patient received UVB phototherapy within 2 weeks of Baseline. 8. Patient received PUVA phototherapy within 4 weeks of Baseline. 9. Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy | 16 weeks | pga x bsa |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment | 16 weeks | PGA |
| Body Surface area | 16 weeks | BSA |
| dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire | 16 weeks | satisfaction determined by patient reported outcomes |
Countries
United States
Outcome results
None listed