Clinical trial NCT02983981: Topical Psoriasis Study for Patients Receiving Biologic Therapy
Official title: An Open-Label, Observational Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) BID in Psoriasis Patients Being Treated With Biologic Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: Taro Pharmaceuticals USA
First posted: 2016-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Psoriasis Severity
timeFrame: 16 weeks
Secondary outcomes:
measure: Psoriasis Severity
timeFrame: 16 weeks
measure: Psoriasis Severity
timeFrame: 16 weeks
measure: Dermatology Life Quality Index
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Director
name: Jerry Bagel, MD
role: PRINCIPAL_INVESTIGATOR
References: