Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985736
• Other study ID #: JB-02
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: January 27, 2017

Study information

• Verified date: March 2024
• Source: Psoriasis Treatment Center of Central New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 27, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Topicort Topical Spray

Locations

Country	Name	City	State
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Psoriasis Treatment Center of Central New Jersey	Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Global Assessment (Scalp Only)	Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe)	16 weeks