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Topical Psoriasis Study for Patients Receiving Biologic Therapy

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ClinicalTrials.gov Identifier: NCT02983981
Recruitment Status : Completed
First Posted : December 6, 2016
Results First Posted : May 7, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Taro Pharmaceuticals USA
Information provided by (Responsible Party):
Psoriasis Treatment Center of Central New Jersey

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Topicort Topical Spray Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Observational Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) BID in Psoriasis Patients Being Treated With Biologic Agents
Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: open label
Topicort topical spray
Drug: Topicort Topical Spray
open label Topicort spray




Primary Outcome Measures :
  1. Psoriasis Severity [ Time Frame: 16 weeks ]
    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 :
  1. Psoriasis Severity [ Time Frame: 16 weeks ]
    Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis

  2. Psoriasis Severity [ Time Frame: 16 weeks ]
    Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.

  3. Dermatology Life Quality Index [ Time Frame: 16 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983981


Sponsors and Collaborators
Psoriasis Treatment Center of Central New Jersey
Taro Pharmaceuticals USA
Investigators
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Principal Investigator: Jerry Bagel, MD Director

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Responsible Party: Psoriasis Treatment Center of Central New Jersey
ClinicalTrials.gov Identifier: NCT02983981     History of Changes
Other Study ID Numbers: JB-01
First Posted: December 6, 2016    Key Record Dates
Results First Posted: May 7, 2018
Last Update Posted: January 14, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Desoximetasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs