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

NCT07641725 | Recruiting

• 1 other identifier: DN-230226-647
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lesions in Patients With Pemphigus Vulgaris

Keywords

Pemphigus vulgaris - Photobiomodulation - Clobetasol propionate - Autoimmune Blistering Diseases.

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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

Secondary Outcomes (4)

• Systemic Corticosteroid Dosage During Treatment of Oral Lesions

  in day 30,60,90

• Oral Health Impact Profile-14 (OHIP-14)

  Patients will be followed up before the treatment and on Days 30,60,90

• Hamilton Anxiety Rating Scale (HAM-A)

  before the treatment and after in days 30,60,90

• Hamilton Depression Rating Scale (HAM-D)

  before the treatment and after in days 30,60,90

Study Arms (3)

Arm 1: Clobetasol propionate 0.05% Mouthwash

EXPERIMENTAL

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

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: * 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

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.

Drug: Clobetasol propionate 0.05% Mouthwash; Drug: clobetasol propionate 0.05% mouthwash + photobiomodulation

Interventions

Clobetasol propionate 0.05% Mouthwash DRUG

Participants will receive topical clobetasol propionate 0.05% mouthwash

Arm 1: Clobetasol propionate 0.05% Mouthwash; Arm 3: Combination Therapy

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.

Arm 3: Combination Therapy

diode laser for photobiomodulation DEVICE

Participants will receive photobiomodulation therapy (low-level laser therapy) by diode laser.

Arm 2: Photobiomodulation Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Oral Medicine, Faculty of Dental medicine

Damascus, Syria

RECRUITING

Related Publications (11)

• 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.

  PMID: 28485307 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.

  PMID: 24727333 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.

  PMID: 30318808 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.

  PMID: 17366763 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.

  PMID: 34491669 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.

  PMID: 29192996 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.

  PMID: 11925534 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.

  PMID: 30022914 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.

  PMID: 32162360 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.

  PMID: 37140257 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.

  PMID: 38550731 BACKGROUND

MeSH Terms

Interventions

Clobetasol; Mouthwashes; Lasers, Semiconductor; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Alhomsi, DDS,MSc,PhD Student

CONTACT

00963993837778; allaalhomsi1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)