Comparison of the Efficacy of Clobetasol Propionate 0.05% Mouthwash, Photobiomodulation, and Their Combination in Managing of Oral Lesions in Patient With Pemphigus Vulgaris.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clobetasol propionate 0.05% Mouthwash, diode laser for photobiomodulation, clobetasol propionate 0.05% mouthwash + photobiomodulation.
- Who it may be relevant to
- Registry conditions: Oral Lesions in Patients With Pemphigus Vulgaris. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Syria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
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.
Interventions
- Drug Clobetasol propionate 0.05% Mouthwash
Participants will receive topical clobetasol propionate 0.05% mouthwash - Device diode laser for photobiomodulation
Participants will receive photobiomodulation therapy (low-level laser therapy) by diode laser. - 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.
Primary outcome measures
- Pemphigus Disease Area Index (PDAI) [Time frame: 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]
- Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) [Time frame: 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]
Secondary outcome measures (4)
- Systemic Corticosteroid Dosage During Treatment of Oral Lesions [Time frame: 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]
- Hamilton Anxiety Rating Scale (HAM-A) [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Syria · 1 center
- Department of Oral Medicine, Faculty of Dental medicine — Damascus
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07641725 · DN-230226-647