Набор по приглашению NCT07050810

Thera-Clean® Microbubbles System in Patients With Skin Diseases

Ранняя фаза I С лечением Epidermolysis Bullosa Ichthyosis Atopic Dermatitis Psoriasis

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: TheraClean.
Кому может быть актуально: Состояния в реестре: Epidermolysis Bullosa, Ichthyosis, Atopic Dermatitis, Psoriasis. Базовые параметры: от 2 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

Thera-Clean® Microbubbles System: A Pilot Study in Patients With Skin Diseases

Обзор

Thera-Clean® Microbubble has proved to improve skin conditions in animals, however little research has been done regarding human subjects. Microbubble technology is a chemical-free therapeutic aimed at clearing foreign and organic matter from hair follicles, eliminating odors, and reducing itch. This hydrotherapy is said to aid in the healing process of inflamed and distressed tissue, relieve pain, and serve to remove contaminated tissue. This study will evaluate the change in skin conditions from the use of Thera-Clean® Microbubble for cleansing and debriding wounds from selected subjects focused on patients with inflammatory skin disease (epidermolysis bullosa, ichthyosis, atopic dermatitis and/or psoriasis). Proper wound care to prevent infection is vitally important for these patients and the options of therapeutics are limited. This study will evaluate the change in skin conditions from the use of Thera-Clean® Microbubble for cleansing and debriding lesional skin.

Вмешательства

Устройство TheraClean
Begins after Week 0 visit and continues through Week 8. Participants will take at least 3 baths/week (20-30 minutes each bath) but may bathe daily, if desired.

Первичные конечные точки

Improvement of skin condition between baseline to Week 4 and baseline to Week 8 using Thera-Clean® microbubble bathing therapy as assessed by the Investigator Global Assessment (IGA). [Срок оценки: 8 weeks]

Вторичные конечные точки (6)

Change in subject's/proxy's perceived visibility and severity of skin disease as assessed by subject reported severity and visibility questionnaires. [Срок оценки: 8 weeks]
Overall improvement in the Dermatology Life Quality Index (>16 yo)/ Children or Proxy-reported Children Dermatology Life Quality Index (4-15 yo)/ Proxy-reported Infant Dermatology Life Quality Index (CDLQI/DLQI/IDLQI) (<4 yo) [Срок оценки: 8 weeks]
Change in Peak Pruritus/Pain Numeric Rating Scale and Peak Pain Numeric Rating Scale scores (0-10 scale) [Срок оценки: 8 weeks]
Change in odor as assessed by subject reported odor assessment questionnaires. [Срок оценки: 8 weeks]
Overall tolerability of device / device usage throughout study as assessed by subject reported tolerability survey. [Срок оценки: 8 weeks]
Overall satisfaction of device / device usage as assessed by subject reported satisfaction survey. [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

Patients 2 years of age or above with psoriasis, atopic dermatitis/eczema, epidermolysis bullosa, or ichthyosis
Skin conditions to be stable for at least the previous 4-week period (patients will continue to use their typical skin treatment regimen throughout the study)