Back to resultsTopical Psoriasis Study for Patients Receiving Biologic Therapy
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Topicort Topical Spray
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Male or female adults ≥ 18 years of age.
- Diagnosis of chronic plaque-type psoriasis.
- Able to give written informed consent prior to performance of any study related procedures.
- Treated with a biologic agent for a minimum of 24 weeks at baseline.
- Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
- 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.
- Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.
Exclusion Criteria:
- >5% Body Surface Area
- Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Pregnant or breast feeding, or considering becoming pregnant during the study.
Malignancy or history of malignancy, except for:
- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
- treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.
- Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- 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).
- 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).
- Patient received UVB phototherapy within 2 weeks of Baseline.
- Patient received PUVA phototherapy within 4 weeks of Baseline.
- Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
open label
Arm Description
Topicort topical spray
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
Psoriasis Severity
Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis
Psoriasis Severity
Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.
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.
Full Information
NCT ID
NCT02983981
First Posted
October 5, 2016
Last Updated
December 28, 2018
Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT02983981
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Taro Pharmaceuticals USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open label
Arm Type
Experimental
Arm Description
Topicort topical spray
Intervention Type
Drug
Intervention Name(s)
Topicort Topical Spray
Intervention Description
open label Topicort spray
Primary Outcome Measure Information:
Title
Psoriasis Severity
Description
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
Secondary Outcome Measure Information:
Title
Psoriasis Severity
Description
Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis
Time Frame
16 weeks
Title
Psoriasis Severity
Description
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
Title
Dermatology Life Quality Index
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female adults ≥ 18 years of age.
Diagnosis of chronic plaque-type psoriasis.
Able to give written informed consent prior to performance of any study related procedures.
Treated with a biologic agent for a minimum of 24 weeks at baseline.
Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
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.
Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.
Exclusion Criteria:
>5% Body Surface Area
Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
Pregnant or breast feeding, or considering becoming pregnant during the study.
Malignancy or history of malignancy, except for:
treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.
Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
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).
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).
Patient received UVB phototherapy within 2 weeks of Baseline.
Patient received PUVA phototherapy within 4 weeks of Baseline.
Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Bagel, MD
Organizational Affiliation
Director
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical Psoriasis Study for Patients Receiving Biologic Therapy
We'll reach out to this number within 24 hrs