An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients

Not Applicable

Recruiting

• Conditions: Psoriasis
• Interventions: Device: Narrowband UVB phototherapy

• Registration Number: NCT03392337
• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey

Brief Summary

A single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response.

Detailed Description

30 subjects will be treated with increasing doses of Narrowband Ultraviolet phototherapy three times weekly for 12 weeks. Patients will then be evaluated every 6 weeks through week 36 to determine maintenance of response.

Study Timeline

• Study Start: 2017-11-07
• Study First Submitted: 2017-12-29
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male or female adults ≥ 18 years of age.
2. Diagnosis of chronic plaque-type psoriasis for at least 6 months
3. Moderate to Severe plaque psoriasis as defined by BSA ≥10 PASI ≥12 IGA ≥3
4. Able to give written informed consent prior to performance of any study related procedures
5. Subject is able to attend Narrowband UVB phototherapy sessions three times a week and all other protocol specified visits
6. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
2. History of photosensitivity
3. Subject has used ustekinumab and/or anti-IL-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.
4. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
5. 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).
6. Patient used topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
7. Initiated within 3 months, planned initiation of, or changes to, concomitant medications that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors ) during the trial
8. Active infections requiring antibiotics in the 2 weeks prior to Baseline
9. Patient received UVB phototherapy within 4 weeks of Baseline.
10. Patient received PUVA phototherapy within 4 weeks of Baseline.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Narrowband UVB phototherapy	Narrowband UVB phototherapy	Open Label Narrowband UVB phototherapy for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Psoriasis area severity index score	12 weeks	PASI 75

Secondary Outcome Measures

Name	Time	Method
Body Surface Area	12 weeks	BSA improvement
Physician's Global Assessments multiplied by Body surface area	12 weeks	PGA x BSA
Physicians Global Assessment	12 weeks	PGA improvement

Trial Locations

Locations (1)

Elise Nelson; 🇺🇸 East Windsor, New Jersey, United States