NCT Number: NCT07641725
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Damascus, Syria
Location status: Recruiting
Abeer Aljoujou, PhD In Oral medicine
PRINCIPAL_INVESTIGATOR
Abeer Aljoujou, PhD in oral medicine
CONTACT
Alaa Alhomsi, Phd student in oral medicine
SUB_INVESTIGATOR
Nemat Alsaghir, Phd in Dermatology
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive topical clobetasol propionate 0.05% mouthwash
Participants will receive photobiomodulation therapy (low-level laser therapy) by diode laser.
Participants will receive combined treatment with topical clobetasol propionate 0.05% mouthwash and photobiomodulation therapy (low-level laser therapy) by diode laser.
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:
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
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
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
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: 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.
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).
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
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).
Contact information is provided by the study sponsor or research team.
Damascus University
Other
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
