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

Drug: Clobetasol propionate 0.05% mouthwash

• Use 3 times daily.
• Rinse and hold in the mouth for 3 minutes per application.
• Do not swallow.
• Duration: 4 weeks. Follow-up instructions: After 4 weeks of therapy, if the patient achieves complete clinical remission, taper the frequency gradually until discontinuation, similar to the tapering of systemic steroids (e.g., reduce from three times daily → twice daily → once daily → every other day → stop).

Patients in the laser group received photobiomodulation therapy using a 650 nm diode laser (continuous wave mode). The laser parameters were as follows:

• Wavelength: 650 nm
• Output power: 100 mW
• Mode: Continuous wave
• Radiant exposure (energy density): 4 J/cm² per session
• Exposure duration: 20 seconds per session (adjusted according to the spot size/area of the lesion to achieve the target fluence of 4 J/cm²) Treatment was applied without contact by maintaining a distance of 1 mm from the lesion and making continuous circular movements from the periphery toward the center of the lesions. Sessions were performed twice a week for a total duration of 30 days (approximately 8-9 sessions, depending on the exact scheduling).

All patients in the intervention arm received combined treatment consisting of:

Clobetasol propionate 0.05% mouthwash, rinsed three times daily for 3 minutes each time, for 30 days, in addition to photobiomodulation therapy using a 650 nm diode laser (continuous mode, 100 mW, 4 J/cm², 20 seconds per session). The laser therapy was administered twice weekly for 30 days. Treatments were performed by a trained clinician according to standardized protocol.

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.

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.

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

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.

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

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).