Topical Psoriasis Study for Patients Receiving Biologic Therapy

Launched by PSORIASIS TREATMENT CENTER OF CENTRAL NEW JERSEY · Dec 2, 2016

Keywords

ClinConnect 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.

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.

Gender

ALL

Eligibility criteria

• 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.