Back to results

Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Topicort Topical Spray

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female adults ≥ 18 years of age.
Diagnosis of chronic plaque-type scalp psoriasis.
IGA of mild or greater (scalp only) determined at screening
Scalp surface area of 30% or greater determined at screening
Able to give written informed consent prior to performance of any study related procedures.
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:

<30% scalp surface area
Scalp Investigator global assessment (IGA) clear or almost clear at time of screening
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.
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).
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.
Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla).
Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline.
Patient received psoralen and Ultraviolet A, 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

Psoriasis Treatment Center of Central New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

open label

Arm Description

Outcomes

Primary Outcome Measures

Investigator Global Assessment (scalp only)

Scalp psoriasis severity scale

Psoriasis Scalp Severity Index

Scalp psoriasis severity scale

Scalp Surface Area

Measures % of scalp affected with psoriasis

Secondary Outcome Measures

body surface area multiplied by physician's global assessement

measures psoriasis severity improvement

scalpdex questionnaire

patient reported outcome

visual analog scale

measures subject assessment of pain

Full Information

NCT ID

NCT02985736

First Posted

October 5, 2016

Last Updated

March 2, 2017

Sponsor

Psoriasis Treatment Center of Central New Jersey

Collaborators

Taro Pharmaceuticals USA

1. Study Identification

Unique Protocol Identification Number

NCT02985736

Brief Title

Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

Official Title

An Open-Label, Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) in Patients With Scalp Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 2016 (undefined)

Primary Completion Date

January 27, 2017 (Actual)

Study Completion Date

January 27, 2017 (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

5. Study Description

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

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)

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

Intervention Type

Drug

Intervention Name(s)

Topicort Topical Spray

Primary Outcome Measure Information:

Title

Investigator Global Assessment (scalp only)

Description

Scalp psoriasis severity scale

Time Frame

16 weeks

Title

Psoriasis Scalp Severity Index

Description

Scalp psoriasis severity scale

Time Frame

16 weeks

Title

Scalp Surface Area

Description

Measures % of scalp affected with psoriasis

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

body surface area multiplied by physician's global assessement

Description

measures psoriasis severity improvement

Time Frame

16 weeks

Title

scalpdex questionnaire

Description

patient reported outcome

Time Frame

16 weeks

Title

visual analog scale

Description

measures subject assessment of pain

Time Frame

16 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female adults ≥ 18 years of age. Diagnosis of chronic plaque-type scalp psoriasis. IGA of mild or greater (scalp only) determined at screening Scalp surface area of 30% or greater determined at screening Able to give written informed consent prior to performance of any study related procedures. 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: <30% scalp surface area Scalp Investigator global assessment (IGA) clear or almost clear at time of screening 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. 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). 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. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla). Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline. Patient received psoralen and Ultraviolet A, PUVA phototherapy within 4 weeks of Baseline. Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.

Facility Information:

Facility Name

Psoriasis Treatment Center of Central New Jersey

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

We'll reach out to this number within 24 hrs