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Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%

6 декабря 2021 г. обновлено: Sun Pharmaceutical Industries Limited

An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Lotion, 0.05% in Subjects 12 to 16 Years 11 Months of Age With Plaque Psoriasis Receiving Two Weeks of Treatment

The objective of this open-label multicentric study is to determine the adrenal suppression potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Subject enrollment will continue until at least 20 subjects with both screening and end of study (EOS) serum cortisol data (pre- and pos-tcosyntropin stimulation) have completed the study without any significant protocol violations (evaluable subjects). This may require the enrollment of approximately 25 subjects.

Обзор исследования

Статус

Прекращено

Вмешательство/лечение

Подробное описание

This is an open label, multicenter study of an investigational formulation of HBP Lotion, 0.05% in male and female subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Approximately 25 subjects with stable plaque psoriasis on at least 10% of their BSA (excluding the face, scalp, groin, axillae and other intertriginous areas), who fulfill the inclusion/exclusion criteria will be enrolled at multiple study sites. All subjects will have a screening CST to assess their HPA axis response at Visit 1 (Screening Visit).

Enrollment into the treatment phase of the study should be timed such that the screening CST will be performed a minimum of 20 days before Baseline Visit. At Visit 2 (Baseline), eligible subjects with normal adrenal function will be eligible to participate in the study.

Subjects will apply HBP Lotion, 0.05% to all psoriasis plaques identified at Visit 2 twice daily (approximately every 12 hours) for the assigned treatment period or until the investigator verifies the subject's psoriasis has cleared. The study is designed to determine the adrenal suppression potential and pharmacokinetic properties of the test article after the subject applies a maximum of approximately 50 grams per week for up to a two week treatment period. All subjects will have a CST to reassess their HPA axis response at EOS (or earlier if the investigator verifies the subject's psoriasis has cleared). In this study, an abnormal Hypothalamujs Pituitary Adrenal axis response to 0.25 milligram dose of cosyntropin is defined as a post-CST serum total cortisol level of less than equal to18 μg/dL.

Eligible subjects will have blood drawn at Screening for baseline drug concentration in plasma. On Day 8, all subjects, regardless of lesion clearance, will have blood drawn for assessment of trough drug concentration in plasma. At the Day 15 visit, subjects who have continued to treat lesions will have a final PK blood sample collected approximately 12 hours after their Day 14 evening application and just prior to the initiation of the CST.

Тип исследования

Интервенционный

Регистрация (Действительный)

16

Фаза

  • Фаза 4

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

    • California
      • Fountain Valley, California, Соединенные Штаты, 92708
        • First OC Dermatology
    • Florida
      • Hialeah, Florida, Соединенные Штаты, 33012
        • Power MD Clinical Research Institute
    • Missouri
      • Saint Joseph, Missouri, Соединенные Штаты, 64506
        • MediSearch Clinical Trials

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 12 лет до 16 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. Subject is male or non-pregnant female and is 12 to 16 years 11 months of age.
  2. Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian has provided informed consent for the subject. 3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% body surface area (BSA) within the Treatment Area. The "Treatment Area" is defined as the entire body exclusive of the face, scalp, groin, axillae, and other intertriginous areas.

4. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.

5. Subject is willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.

6. Females must have a negative urine pregnancy test (UPT) at the Screening and Baseline Visits and agree to use an effective form of birth control for the duration of the study.

Exclusion Criteria:

  1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
  2. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
  3. Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function (e.g., Addison's Disease, Cushing's Syndrome) or which exposes the subject to an unacceptable risk by study participation.
  4. Subject has used any phototherapy (including laser), photochemotherapy or systemic psoriasis therapy including methotrexate, retinoids, cyclosporine or biologics within 30 days prior to the initiation of treatment with the test article.
  5. Subject has used systemic corticosteroids (including oral or intramuscular) or topical, inhaled or intranasal corticosteroids within 30 or 14 days, respectively, prior to Part B of the Screening Visit and/or the subject has used systemic or topical corticosteroids between Part B of the Screening Visit and the initiation of treatment.
  6. Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease.
  7. Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to the initiation of treatment with the test article.
  8. Subject has used emollients/moisturizers on areas to be treated within one day prior to the initiation of treatment with the test article.
  9. Subject is currently using lithium or Plaquenil (hydroxychloroquine).
  10. Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has not been stabilized, in the opinion of the investigator.
  11. Subject has a history of sensitivity to any of the ingredients in the test article.
  12. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  13. Subject is currently enrolled in an investigational drug or device study.
  14. Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Screening).
  15. Subject has been previously enrolled in this study and treated with the test article.
  16. Subject has an irregular sleep schedule or works night shifts (cortisol levels exhibit physiological diurnal variation).
  17. Subject has a screening Cosyntropin Stimulation Test (CST) with a post 30-minute stimulation cortisol level of less than equal to 18 μg/dL.
  18. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Halobetasol lotion treatment arm
All subjects will receive Halobetasol Topical Lotion, 0.05%.
Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Другие имена:
  • Halobetasol topical lotion 0.05%

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Investigator's Global Assessment
Временное ограничение: Day 15
The IGA score (5-point scale of 0 to 4: 0[clear]; 1[almost clear]; 2[mild]; 3[moderate]; 4[severe]) is an evaluation of the overall severity of a subject's psoriasis in the Treatment Area and takes into consideration the 3 individual characteristics of psoriasis (scaling, erythema, and plaque elevation).
Day 15
Percent BSA Affected With Disease
Временное ограничение: Day 15
The Percent Body Surface Area (BSA) Affected with Disease was defined as the BSA which was affected with psoriasis within the Treatment Area.
Day 15
Percent Body Surface Area Treated With Test Article
Временное ограничение: Day 8
The Percent Body Surface Area Treated with Test Article was defined as the BSA which was affected with psoriasis within the Treatment Area that was treated.
Day 8
Number of Subjects With Abnormal Hypothalamus-Pituitary-Adrenal Axis Response
Временное ограничение: Day 15
An abnormal Hypothalamus-Pituitary-Adrenal (HPA) axis was response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS)
Day 15

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

  • Учебный стул: Stephanie Magajna, MS, Therapeutics, Inc.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

21 марта 2017 г.

Первичное завершение (Действительный)

12 августа 2019 г.

Завершение исследования (Действительный)

12 августа 2019 г.

Даты регистрации исследования

Первый отправленный

18 апреля 2017 г.

Впервые представлено, что соответствует критериям контроля качества

6 июля 2017 г.

Первый опубликованный (Действительный)

11 июля 2017 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

7 декабря 2021 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

6 декабря 2021 г.

Последняя проверка

1 декабря 2021 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

Нет

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Halobetasol Topical Lotion

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