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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Damascus University
- Enrollment
- 30
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
This study employs a single-blind design where participants remain unaware of their specific group allocation. Due to the technical nature of the interventions, the clinicians administering the treatments cannot be blinded. To maintain participant blinding, those in the clobetasol-only group will undergo a "sham" photobiomodulation procedure, which replicates the visual and auditory cues of the laser device without delivering active energy. Conversely, participants in the PBMT-only group will be provided with a placebo mouthwash, identical in appearance and administration to the active clobetasol rinse. To further ensure objectivity and minimize bias, all clinical outcomes will be evaluated by independent assessors who are not involved in the treatment allocation or administration process.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.