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Набор скоро начнётся NCT07666620

Efficacy of Clobetasol Vs Intralesional Triamcinolone in Lichen Planus Treatment

Фаза IV С лечением Hypertrophic Lichen Planus

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: Clobetasol propionate 0.05% cream, Triamcinolone acetonide 10 mg/mL injection.
Кому может быть актуально
Состояния в реестре: Hypertrophic Lichen Planus. 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
Пакистан
Следующий шаг
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Официальное название

Comparative Efficacy of Clobetasol 0.05% Versus Intralesional Triamcinolone in Treatment of Hypertrophic Lichen Planus at a Tertiary Care Hospital

Обзор

The purpose of this study is to compare the efficacy and safety of two standard corticosteroid treatments for hypertrophic lichen planus (HLP), a chronic inflammatory skin condition that causes thick, intensely itchy plaques. Patients participating in the study will be randomly assigned to one of two treatment groups: * Group A will apply a superpotent topical steroid cream (Clobetasol propionate 0.05%) to their lesions twice daily for 12 weeks. * Group B will receive intralesional injections of a steroid medication (Triamcinolone acetonide 10 mg/mL) directly into the lesions once every 4 weeks for a total of four sessions over 12 weeks. The primary objective is to determine which approach achieves a better reduction in plaque thickness and severity using the Lichen Planus Severity Index (LPSI) score at week 12. The study will also track changes in itching severity using a Visual Analog Scale (VAS), changes in overall lesion surface area, and monitor for any local side effects such as skin thinning or pigment changes.

Подробное описание

This is a randomized, single-blind (outcome assessor blinded), parallel-group clinical trial conducted at the Department of Dermatology, Combined Military Hospital, Abbottabad, Pakistan. A total of 116 eligible participants (58 per group) aged 18 and older with a confirmed diagnosis of hypertrophic lichen planus will be enrolled via consecutive sampling. Group A will receive topical Clobetasol propionate 0.05% cream twice daily for 12 weeks. Group B will receive intralesional Triamcinolone acetonide (10 mg/mL, 0.1-0.2 mL per site spaced 1 cm apart, max 0.5 mL/cm²) at weeks 0, 4, 8, and 12. Outcome parameters (LPSI, pruritus VAS, and lesion area in cm²) will be recorded at baseline, week 4, week 8, and week 12 to statistically evaluate and compare clinical response rates and the incidence of adverse drug reactions between the two treatment modalities.

Вмешательства

  • Препарат Clobetasol propionate 0.05% cream
    Superpotent topical corticosteroid cream applied twice daily for 12 weeks (p. 4). Patients are instructed to avoid washing the area for 30 minutes after application
  • Препарат Triamcinolone acetonide 10 mg/mL injection
    Corticosteroid suspension injected directly into the lesions (intralesional) at weeks 0, 4, 8, and 12

Первичные конечные точки

  • Clinical outcome [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Age >= 18 years, both genders\[cite: 1\]
  • Confirmed clinically as hypertrophic lichen planus with Lichen Planus Severity Index (LPSI) score >= 2 at baseline and Pruritus Visual Analog Scale (VAS) score >= 4 at baseline\[cite: 1\]
  • No use of topical or intralesional treatment of lichen planus within the last 4 weeks\[cite: 1\]
  • Able to provide written informed consent in English or Urdu language\[cite: 1\]

Критерии исключения

  • Drug-induced lichenoid lesions\[cite: 1\]
  • Pregnant or lactating women\[cite: 1\]
  • Uncontrolled diabetes mellitus or any other active skin infections\[cite: 1\]
  • Necessity of systemic corticosteroids or immunosuppressive drugs as the primary treatment\[cite: 1\]
  • Previous history of hypersensitivity or sensitivity to the study medicines (clobetasol propionate or triamcinolone acetonide)\[cite: 1\]
  • Refusal to provide informed consent\[cite: 1\]

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Department of Dermatology, Combined Military Hospital (CMH) — Abbottabad

Публикации

  • Clim A, Maranduca MA, Filip N, Tanase DM, Floria M, Pinzariu AC, Popa IP, Nemteanu R, Cozma TC, Faur FI, Serban DN, Scripcariu DV, Serban IL. The Influence of Atorvastatin Treatment on Homocysteine Metabolism and Oxidative Stress in an Experimental Model of Diabetic Rats. Life (Basel). 2024 Nov 2;14(11):1414. doi: 10.3390/life14111414. PMID 39598213
  • Sado M, Shirahase J, Yoshimura K, Miura Y, Yamamoto K, Tabuchi H, Kato M, Mimura M. Predictors of repeated sick leave in the workplace because of mental disorders. Neuropsychiatr Dis Treat. 2014 Jan 29;10:193-200. doi: 10.2147/NDT.S55490. eCollection 2014. PMID 24511234
  • Guo L, Zhang H, Liu P, Mi T, Ha D, Su L, Huang L, Shi Y, Zhang J. Preclinical Assessment of Paclitaxel- and Trastuzumab-Delivering Magnetic Nanoparticles Fe3O4 for Treatment and Imaging of HER2-Positive Breast Cancer. Front Med (Lausanne). 2021 Oct 28;8:738775. doi: 10.3389/fmed.2021.738775. eCollection 2021. PMID 34778301

Идентификаторы

NCT: NCT07666620 · Derma Cmh Abbottabad

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗