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

RecruitingNAAges 18 Years - 80 YearsAllDamascus University
NCT07641725 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 complica

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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. 2. Presence of active erosive or ulcerative oral lesions with a maximum diameter exceeding 1 cm. 3. Patients currently maintained on a stable systemic corticosteroid regimen not exceeding 1 mg/kg/day. Exclusion Criteria: 1. Co-existing chronic systemic conditions, including significant gastrointestinal disorders or uncontrolled diabetes mellitus. 2. History or current evidence of malignancy. 3. Concurrent use of systemic antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), or hormonal therapies that may interfere with the study outcomes. 4. Pregnancy or active lactation. Note: These criteria are strictly enforced to ensure that the study population remains homogeneous regarding the systemic treatment protocol.
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What it tests

  • Clobetasol propionate 0.05% Mouthwash
  • diode laser for photobiomodulation
  • clobetasol propionate 0.05% mouthwash + photobiomodulation
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Where

1 site
Department of Oral Medicine, Faculty of Dental medicine
Damascus, Syria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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