Идёт набор NCT04087629

StrataCTX® as a Steroid Sparing Device

Без фазы С лечением CTCL

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: StrataCTX® gel.
Кому может быть актуально: Состояния в реестре: CTCL. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use as a Steroid Sparing Agent

Обзор

The purpose is to determine if StrataCTX® can be used as a steroid sparing agent for the treatment of cutaneous reactions related to, cutaneous T Cell lymphoma (CTCL) and chemotherapy/immunotherapy treatments than the current standard treatment - topical steroids - in people who are receiving treatment for CTCL, or chemotherapy/immunotherapy for solid/hematologic malignancies. Subjects will have CTCL and are being treated with topical steroids, or being treated with chemotherapy/immunotherapy for another condition and have had cutaneous reactions that have warranted initiation of topical steroids.

Подробное описание

Topical steroids are the mainstays of treatment for many cutaneous reactions and disorders. Steroids are known to cause many side effects and few effective pharmacologic alternatives exist. Contact dermatitis is observed in 56% of patients with cutaneous T-cell lymphoma (CTCL) being treated with topical mechlorethamine gel. This usually requires chronic treatment with mid-to high-potency steroids. Numerous chemo/immunotherapies are associated with cutaneous reactions including paronychia, hand and foot syndrome, and acneiform rash. Skin toxicity often requires dose reduction of cancer therapies and a variety of skin directed therapies including topical antibiotics and topical steroids. Cutaneous reactions are often the earliest manifestation of acute graft versus host disease. Skin manifestations can be debilitating and treatment usually requires high potency topical steroids. Additional therapies are needed for the treatment of disorders that rely on topical steroids.

Вмешательства

Устройство StrataCTX® gel
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis

Первичные конечные точки

Change in Pruritus Visual Analogue Scale (VAS) Score [Срок оценки: Screening through 3 months]

Вторичные конечные точки (3)

Change in SKINDEX-16 Quality of Life (QOL) Score [Срок оценки: Screening through 3 months]
Change in the Rate of Primary Skin Reactions [Срок оценки: Screening through 3 months]
Change in Topical Steroid Use [Срок оценки: Day 30 through 3 months]

Критерии участия

Критерии включения

Age ≥ 18 years
Ability to sign informed consent document
Patient with a diagnosis of CTCL who have contact dermatitis to topical mechlorethamine gel
Patients with a diagnosis of CTCL who have intractable pruritis
Patients with a diagnosis of CTCL who rely heavily on topical steroids for symptomatic relief
Patients on chemo/immunotherapy with drug induced rash