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

June 8, 2026 updated by: Damascus University

Evaluation of the Effectiveness of Clobetasol Propionate 0.05% and Photobiomodulation in the Management of Oral Lesions in Patients With Pemphigus Vulgaris. (Three-arm Randomized Controlled Clinical Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Syria
      • Damascus, Syria
        • Recruiting
        • Department of Oral Medicine, Faculty of Dental medicine
        • Contact:
        • Sub-Investigator:
          • Alaa Alhomsi, Phd student in oral medicine
        • Principal Investigator:
          • Abeer Aljoujou, PhD In Oral medicine
        • Principal Investigator:
          • Nemat Alsaghir, Phd in Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Presence of active erosive or ulcerative oral lesions with a maximum diameter exceeding 1 cm.
  3. Patients currently maintained on a stable systemic corticosteroid regimen not exceeding 1 mg/kg/day.

Exclusion Criteria:

  1. Co-existing chronic systemic conditions, including significant gastrointestinal disorders or uncontrolled diabetes mellitus.
  2. History or current evidence of malignancy.
  3. Concurrent use of systemic antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), or hormonal therapies that may interfere with the study outcomes.
  4. Pregnancy or active lactation. Note: These criteria are strictly enforced to ensure that the study population remains homogeneous regarding the systemic treatment protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Clobetasol propionate 0.05% Mouthwash

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
Participants will receive topical clobetasol propionate 0.05% mouthwash
Experimental: Arm 2: Photobiomodulation Therapy

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
Participants will receive photobiomodulation therapy (low-level laser therapy) by diode laser.
Experimental: Arm 3: Combination Therapy

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
Participants will receive topical clobetasol propionate 0.05% mouthwash
Drug: clobetasol propionate 0.05% mouthwash + photobiomodulation
Participants will receive combined treatment with topical clobetasol propionate 0.05% mouthwash and photobiomodulation therapy (low-level laser therapy) by diode laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pemphigus Disease Area Index (PDAI)
Time Frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90

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)
Time Frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90

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)
Time Frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90

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)
Time Frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic Corticosteroid Dosage During Treatment of Oral Lesions
Time Frame: in day 30,60,90
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
Oral Health Impact Profile-14 (OHIP-14)
Time Frame: Patients will be followed up before the treatment and on Days 30,60,90
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)
Time Frame: before the treatment and after in days 30,60,90

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)
Time Frame: before the treatment and after in days 30,60,90

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DN-230226-647

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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