An interventional study of Clobetasol propionate 0.05% Mouthwash and diode laser for photobiomodulation in Oral Lesions in Patients With Pemphigus Vulgaris, sponsored by Damascus University. Recruiting at 1 site in Syria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
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.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 53 interventional studies indexed under Pemphigus.
Browse Pemphigus studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Clobetasol propionate 0.05% Mouthwash
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).
Device: diode laser for photobiomodulation
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.
Drug: Clobetasol propionate 0.05% Mouthwash · Drug: clobetasol propionate 0.05% mouthwash + photobiomodulation
Participants will receive topical clobetasol propionate 0.05% mouthwash
Participants will receive photobiomodulation therapy (low-level laser therapy) by diode laser.
Drug page: Clobetasol
Participants 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.
Time frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
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.
Time frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
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
Time frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
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.
Time frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
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.
Time frame: in day 30,60,90
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).
Time frame: Patients will be followed up before the treatment and on Days 30,60,90
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
Time frame: before the treatment and after in days 30,60,90
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).
Time frame: before the treatment and after in days 30,60,90
Plan to share: No
Started Nov 2025 (actual). Primary completion is estimated for Sep 2026, 10 months after the start.
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Studies of the drug tested here: Clobetasol