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

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.

Timeline

Start

2025-11-01

Primary completion

2026-09-01

Completion

2026-12-01

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications