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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Narrowband UVB phototherapy
  Ultraviolet B phototherapy

Первичные конечные точки

• Psoriasis area severity index score [Срок оценки: 12 weeks]

Вторичные конечные точки (3)

• Physicians Global Assessment [Срок оценки: 12 weeks]
• Body Surface Area [Срок оценки: 12 weeks]
• Physician's Global Assessments multiplied by Body surface area [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
• History of photosensitivity
• 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.
• 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).
• 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).
• 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
• Active infections requiring antibiotics in the 2 weeks prior to Baseline
• Patient received UVB phototherapy within 4 weeks of Baseline.
• Patient received PUVA phototherapy within 4 weeks of Baseline.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Elise Nelson — East Windsor

Идентификаторы

NCT: NCT03392337 · PTC02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗