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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Clobetasol propionate 0.05% Mouthwash | Experimental | Drug: Clobetasol propionate 0.05% mouthwash
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| Arm 2: Photobiomodulation Therapy | Experimental | Patients in the laser group received photobiomodulation therapy using a 650 nm diode laser (continuous wave mode). The laser parameters were as follows:
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| Arm 3: Combination Therapy | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobetasol propionate 0.05% Mouthwash | Drug | Participants will receive topical clobetasol propionate 0.05% mouthwash |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
In the context of this research, only the component assessing oral mucosal involvement will be utilized. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | in day 30,60,90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaa Alhomsi, DDS,MSc,PhD Student | Contact | 00963993837778 | allaalhomsi1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Abeer Aljoujou, PhD In Oral medicine | Associate Professor, Department of Oral Medicine, Faculty of Dental medicine, Damascus University, Damascus, Syria. | Principal Investigator |
| Nemat Alsaghir, PhD in dermatology | Lecturer, Department of Dermatology, Faculty of Medicine, Damascus University, Damascus, Syria. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral Medicine, Faculty of Dental medicine | Recruiting | Damascus | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28485307 | Background | Chen G, Yang B, Zhang Z, Yang Q, Yan X, Murrell DF, Zhang F. Chinese version of the treatment of autoimmune bullous disease quality of life questionnaire: Reliability and validity. Indian J Dermatol Venereol Leprol. 2018 Jul-Aug;84(4):431-436. doi: 10.4103/ijdvl.IJDVL_538_16. | |
| 24727333 | Background | Noce CW, Gomes A, Shcaira V, Correa ME, Moreira MC, Silva Junior A, Goncalves LS, Garnica M, Maiolino A, Torres SR. Randomized double-blind clinical trial comparing clobetasol and dexamethasone for the topical treatment of symptomatic oral chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2014 Aug;20(8):1163-8. doi: 10.1016/j.bbmt.2014.04.009. Epub 2014 Apr 13. |
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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.
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| diode laser for photobiomodulation | Device | Participants will receive photobiomodulation therapy (low-level laser therapy) by diode laser. |
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| clobetasol propionate 0.05% mouthwash + photobiomodulation | Drug | Participants will receive combined treatment with topical clobetasol propionate 0.05% mouthwash and photobiomodulation therapy (low-level laser therapy) by diode laser. |
|
| 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. | Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 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). | 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 | 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). | before the treatment and after in days 30,60,90 |
| Principal Investigator |
| 30318808 | Background | Murrell DF, Caux F, Prost-Squarcioni C. Is the Oral Disease Severity Score going to be useful for dermatologists when assessing pemphigus? Br J Dermatol. 2018 Oct;179(4):816-817. doi: 10.1111/bjd.16911. No abstract available. |
| 17366763 | Background | Lara RN, da Guerra EN, de Melo NS. Macroscopic and microscopic effects of GaAIAs diode laser and dexamethasone therapies on oral mucositis induced by fluorouracil in rats. Oral Health Prev Dent. 2007;5(1):63-71. |
| 34491669 | Background | Jindal A, Rao C, Pai SB, Rao R. Utility of oral mucosa as a substrate for the serodiagnosis of pemphigus: A descriptive analysis. Indian J Dermatol Venereol Leprol. 2022 Mar-Apr;88(2):156-161. doi: 10.25259/IJDVL_469_20. |
| 29192996 | Background | Harman KE, Brown D, Exton LS, Groves RW, Hampton PJ, Mohd Mustapa MF, Setterfield JF, Yesudian PD. British Association of Dermatologists' guidelines for the management of pemphigus vulgaris 2017. Br J Dermatol. 2017 Nov;177(5):1170-1201. doi: 10.1111/bjd.15930. No abstract available. |
| 11925534 | Background | Gonzalez-Moles MA, Morales P, Rodriguez-Archilla A, Isabel IR, Gonzalez-Moles S. Treatment of severe chronic oral erosive lesions with clobetasol propionate in aqueous solution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Mar;93(3):264-70. doi: 10.1067/moe.2002.120522. |
| 30022914 | Background | de Macedo AG, Bertges ER, Bertges LC, Mendes RA, Bertges TABS, Bertges KR, Aarestrup FM. Pemphigus Vulgaris in the Mouth and Esophageal Mucosa. Case Rep Gastroenterol. 2018 Jun 15;12(2):260-265. doi: 10.1159/000489299. eCollection 2018 May-Aug. |
| 32162360 | Background | Dal Pra KJ, de Assis Tristao SDSS, Franco JB, Matias DT, Carrillo CM, de Melo Peres MPS, Ribas PF. Oral management of pemphigus vulgaris in the intensive care unit. Spec Care Dentist. 2020 May;40(3):280-284. doi: 10.1111/scd.12454. Epub 2020 Mar 12. |
| 37140257 | Background | Amadori F, Bardellini E, Veneri F, Majorana A. Photobiomodulation laser therapy in pemphigus vulgaris oral lesions: A randomized, double-blind, controlled study. Stomatologija. 2022;24(3):80-84. |
| 38550731 | Background | ALhomsi A, Aljoujou AA, Mashlah A, Al Ahdab S, Al Jabban H. Combined treatment of dexamethasone mouthwash and low-level laser therapy in the management of aphthous-like ulcers caused by nonsteroidal anti-inflammatory drugs: A case report. Clin Case Rep. 2024 Mar 27;12(4):e8723. doi: 10.1002/ccr3.8723. eCollection 2024 Apr. |
| ID | Term |
|---|---|
| D002990 | Clobetasol |
| D009067 | Mouthwashes |
| D054023 | Lasers, Semiconductor |
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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