Comparison of the Efficacy of Clobetasol Propionate 0.05% Mouthwash, Photobiomodulation, and Their Combination in Managing of Oral Lesions in Patient With Pemphigus Vulgaris.

Официальное название

Evaluation of the Effectiveness of Clobetasol Propionate 0.05% and Photobiomodulation in the Management of Oral Lesions in Patients With Pemphigus Vulgaris. (Three-arm Randomized Controlled Clinical Study)

Обзор

Pemphigus vulgaris (PV) is a chronic, potentially life-threatening autoimmune mucocutaneous disorder that significantly impairs patients' quality of life. While systemic corticosteroids and immunosuppressants remain the standard of care, many patients suffer from persistent, painful oral lesions that exhibit delayed healing or poor response to conventional systemic protocols. This clinical trial investigates the efficacy and safety of supportive topical interventions: clobetasol propionate 0.05% mouthwash and photobiomodulation therapy (PBMT)-a non-invasive approach designed to accelerate tissue repair, and their combination. The primary objective is to identify effective adjunctive topical therapies that can facilitate the healing of oral erosions, mitigate pain, and potentially allow for a reduction in systemic medication dosages, thereby minimizing long-term treatment-related complications and improving overall patient outcomes.

Подробное описание

Patients with pemphigus vulgaris often experience debilitating oral pain, which severely restricts their ability to maintain adequate nutrition and hydration. Furthermore, the presence of extensive oral ulcers and erosions poses a significant risk for secondary bacterial or fungal infections. These challenges underscore the clinical necessity for effective topical adjunctive treatments to complement systemic therapy. By enhancing local lesion management, these topical modalities aim to accelerate clinical.

Вмешательства

• Препарат Clobetasol propionate 0.05% Mouthwash
  Participants will receive topical clobetasol propionate 0.05% mouthwash
• Устройство diode laser for photobiomodulation
  Participants will receive photobiomodulation therapy (low-level laser therapy) by diode laser.
• Препарат clobetasol propionate 0.05% mouthwash + photobiomodulation
  Participants will receive combined treatment with topical clobetasol propionate 0.05% mouthwash and photobiomodulation therapy (low-level laser therapy) by diode laser.

Первичные конечные точки

• Pemphigus Disease Area Index (PDAI) [Срок оценки: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90]
• Oral Disease Severity Score (ODSS) [Срок оценки: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90]
• Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) [Срок оценки: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90]
• physician Global Assessment (PGA) [Срок оценки: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90]

Вторичные конечные точки (4)

• Systemic Corticosteroid Dosage During Treatment of Oral Lesions [Срок оценки: in day 30,60,90]
• Oral Health Impact Profile-14 (OHIP-14) [Срок оценки: Patients will be followed up before the treatment and on Days 30,60,90]
• Hamilton Anxiety Rating Scale (HAM-A) [Срок оценки: before the treatment and after in days 30,60,90]
• Hamilton Depression Rating Scale (HAM-D) [Срок оценки: before the treatment and after in days 30,60,90]

Критерии участия

Критерии включения

• Confirmed diagnosis of Pemphigus Vulgaris based on clinical presentation, histopathology, and immunopathological findings (positive direct and indirect immunofluorescence), according to World Health Organization (WHO) standards.
• Presence of active erosive or ulcerative oral lesions with a maximum diameter exceeding 1 cm.
• Patients currently maintained on a stable systemic corticosteroid regimen not exceeding 1 mg/kg/day.

Критерии исключения

• Co-existing chronic systemic conditions, including significant gastrointestinal disorders or uncontrolled diabetes mellitus.
• History or current evidence of malignancy.
• Concurrent use of systemic antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), or hormonal therapies that may interfere with the study outcomes.
• Pregnancy or active lactation. Note: These criteria are strictly enforced to ensure that the study population remains homogeneous regarding the systemic treatment protocol.

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

Syria · 1 центр

• Department of Oral Medicine, Faculty of Dental medicine — Damascus

Публикации

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• Noce CW, Gomes A, Shcaira V, Correa ME, Moreira MC, Silva Junior A, Goncalves LS, Garnica M, Maiolino A, Torres SR. Randomized double-blind clinical trial comparing clobetasol and dexamethasone for the topical treatment of symptomatic oral chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2014 Aug;20(8):1163-8. doi: 10.1016/j.bbmt.2014.04.009. Epub 2014 Apr 13. PMID 24727333
• Murrell DF, Caux F, Prost-Squarcioni C. Is the Oral Disease Severity Score going to be useful for dermatologists when assessing pemphigus? Br J Dermatol. 2018 Oct;179(4):816-817. doi: 10.1111/bjd.16911. No abstract available. PMID 30318808
• Lara RN, da Guerra EN, de Melo NS. Macroscopic and microscopic effects of GaAIAs diode laser and dexamethasone therapies on oral mucositis induced by fluorouracil in rats. Oral Health Prev Dent. 2007;5(1):63-71. PMID 17366763
• Jindal A, Rao C, Pai SB, Rao R. Utility of oral mucosa as a substrate for the serodiagnosis of pemphigus: A descriptive analysis. Indian J Dermatol Venereol Leprol. 2022 Mar-Apr;88(2):156-161. doi: 10.25259/IJDVL_469_20. PMID 34491669
• Harman KE, Brown D, Exton LS, Groves RW, Hampton PJ, Mohd Mustapa MF, Setterfield JF, Yesudian PD. British Association of Dermatologists' guidelines for the management of pemphigus vulgaris 2017. Br J Dermatol. 2017 Nov;177(5):1170-1201. doi: 10.1111/bjd.15930. No abstract available. PMID 29192996
• Gonzalez-Moles MA, Morales P, Rodriguez-Archilla A, Isabel IR, Gonzalez-Moles S. Treatment of severe chronic oral erosive lesions with clobetasol propionate in aqueous solution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Mar;93(3):264-70. doi: 10.1067/moe.2002.120522. PMID 11925534
• de Macedo AG, Bertges ER, Bertges LC, Mendes RA, Bertges TABS, Bertges KR, Aarestrup FM. Pemphigus Vulgaris in the Mouth and Esophageal Mucosa. Case Rep Gastroenterol. 2018 Jun 15;12(2):260-265. doi: 10.1159/000489299. eCollection 2018 May-Aug. PMID 30022914

Идентификаторы

NCT: NCT07641725 · DN-230226-647

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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