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.
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.
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.
Parallel
Clobetasol propionate 0.05% Mouthwash
DrugParticipants will receive topical clobetasol propionate 0.05% mouthwash
diode laser for photobiomodulation
DeviceParticipants will receive photobiomodulation therapy (low-level laser therapy) by diode laser.
clobetasol propionate 0.05% mouthwash + photobiomodulation
DrugParticipants will receive combined treatment with topical clobetasol propionate 0.05% mouthwash and photobiomodulation therapy (low-level laser therapy) by diode laser.
Pemphigus Disease Area Index (PDAI)
The PDAI is a validated clinical scoring system used to assess disease activity in pemphigus vulgaris. It evaluates the extent and severity of skin and mucosal lesions, including lesion number and size. Higher scores indicate more severe disease activity. These scores are categorized as follows: 250 points associated with disease activity, distributed as follows: * 120 points for the skin * 120 points for the mucous membranes * 10 points for the scalp. 30 points for tissue damage Disease activity, as well as the number and size of lesions in each specific region, are considered crucial factors within this scoring system. In the context of this research, only the component assessing oral mucosal involvement will be utilized.
Oral Disease Severity Score (ODSS)
The ODSS is a site-specific scoring system designed to assess the severity of oral mucosal involvement in pemphigus vulgaris. It quantifies the number, size, and distribution of oral lesions, as well as their functional impact on pain and eating ability. The total score is 106 points, calculated by summing the region score, the disease activity score, and the pain score.
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
The ABSIS is a composite score used to assess disease severity in autoimmune blistering disorders. It includes evaluation of the extent of skin and mucosal involvement and incorporates patient-reported symptoms such as pain and difficulty in eating. It provides both objective and subjective measures of disease severity. The overall assessment consists of a total score of 208 points (100 points for skin lesions, 100 points for oral lesions, and 8 points for self-reported discomfort during eating). In this study, only the oral mucosal component of the score will be used. This component evaluates 20 distinct anatomical sites in the oral cavity. A score of 0 (absence of any lesion) or 1 (presence of a lesion) is assigned to each site, resulting in a maximum score of 20 points for the extent of oral lesions. The second part of the score is dedicated to symptom severity. It details the degree of discomfort experienced while eating and drinking, with a maximum score of 10 points
physician Global Assessment (PGA)
The PGA is a clinician-reported global measure of overall disease severity and activity. It is based on the physician's overall clinical judgment, integrating physical examination findings and disease extent into a single numerical score. It consists of a 10-point visual analogue scale (VAS) that ranges from 0 (representing ideal health or complete clearance) to 10 (representing the worst possible disease state). Physicians rate the patient according to their global clinical impression of the disease severity.
Systemic Corticosteroid Dosage During Treatment of Oral Lesions
One of the inclusion criteria requires that the patient is on a systemic corticosteroid dose that does not exceed 1 mg/kg/day. During the study, the systemic corticosteroid dose will be assessed whenever the dermatologist decides to reduce it in response to improvement of the oral lesions' symptoms.
Oral Health Impact Profile-14 (OHIP-14)
The Oral Health Impact Profile-14 (OHIP-14) is a widely used, short-form questionnaire designed to measure the impact of oral health problems on an individual's oral health-related quality of life (OHRQoL).
Hamilton Anxiety Rating Scale (HAM-A)
The HAM-A is a 14-item clinician-rated scale that assesses the severity of anxiety symptoms over the past week. It covers both psychic anxiety (mental agitation, psychological distress, fears, and mood) and somatic anxiety (physical manifestations such as cardiovascular, respiratory, gastrointestinal, genitourinary, and muscular symptoms). Each item is scored on a 5-point Likert-type scale ranging from 0 (not present) to 4 (severe/incapacitating). The total score ranges from 0 to 56
Hamilton Depression Rating Scale (HAM-D)
The HAM-D (most commonly the 17-item version) is one of the most established clinician-administered scales for assessing the severity of depressive symptoms over the past week. It evaluates core domains including depressed mood, feelings of guilt, suicidal ideation, insomnia, psychomotor agitation or retardation, anxiety, somatic symptoms, and loss of interest or energy. Items are scored on either a 3-point (0-2) or 5-point (0-4) scale, depending on the item, with a total score range of 0 to 52 (for the 17-item version).
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