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Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

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ClinicalTrials.gov Identifier: NCT02985736
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Taro Pharmaceuticals USA
Information provided by (Responsible Party):
Psoriasis Treatment Center of Central New Jersey

Brief Summary:
A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis

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

Detailed Description:
All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other body areas affected by plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla)

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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, Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) in Patients With Scalp Psoriasis
Study Start Date : September 2016
Actual Primary Completion Date : January 27, 2017
Actual Study Completion Date : January 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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



Primary Outcome Measures :
  1. Investigator Global Assessment (scalp only) [ Time Frame: 16 weeks ]
    Scalp psoriasis severity scale

  2. Psoriasis Scalp Severity Index [ Time Frame: 16 weeks ]
    Scalp psoriasis severity scale

  3. Scalp Surface Area [ Time Frame: 16 weeks ]
    Measures % of scalp affected with psoriasis


Secondary Outcome Measures :
  1. body surface area multiplied by physician's global assessement [ Time Frame: 16 weeks ]
    measures psoriasis severity improvement

  2. scalpdex questionnaire [ Time Frame: 16 weeks ]
    patient reported outcome

  3. visual analog scale [ Time Frame: 16 weeks ]
    measures subject assessment of pain



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 scalp psoriasis.
  3. IGA of mild or greater (scalp only) determined at screening
  4. Scalp surface area of 30% or greater determined at screening
  5. Able to give written informed consent prior to performance of any study related procedures.
  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. <30% scalp surface area
  2. Scalp Investigator global assessment (IGA) clear or almost clear at time of screening
  3. Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
  4. Pregnant or breast feeding, or considering becoming pregnant during the study.
  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. Use of ustekinumab and/or anti-IL-17 (interleukin 17) biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
  8. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla).
  9. Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline.
  10. Patient received psoralen and Ultraviolet A, PUVA phototherapy within 4 weeks of Baseline.
  11. 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): NCT02985736


Locations
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United States, New Jersey
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States, 08520
Sponsors and Collaborators
Psoriasis Treatment Center of Central New Jersey
Taro Pharmaceuticals USA

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Responsible Party: Psoriasis Treatment Center of Central New Jersey
ClinicalTrials.gov Identifier: NCT02985736     History of Changes
Other Study ID Numbers: JB-02
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
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