Effect of insulin on pemphigus oral ulcers

INTERVENTION: Intervention 1: The therapeutic intervention in this study involves the daily topical application of regular insulin (produced by Iran Hormone Company) at a dose of 1 unit per milliliter, prepared in a 120-milliliter volume (sufficient for 2 months of use) by the principal investigator and self-administered by the patient. Insulin solutions are labeled with non-identifiable codes to maintain blinding and are provided to the patients. Patients are instructed to rinse their mouth with 0.2% chlorhexidine solution for 30 seconds before use. They then apply the insulin solution topically to the base of oral gingivitis lesions twice daily. Patients are also trained to distribute the solution evenly across affected areas and to continue this process daily. They are instructed to avoid eating or drinking for 30 minutes after application. Any adverse effects (such as redness, swelling, local pain, headache, or dizziness) are recorded by a dermatologist during follow-up visits based on the patient’s history and managed as needed. This treatment continues for 4 months. Intervention 2: The control group in this study uses normal saline solution, prepared in a 120-milliliter volume (sufficient for 2 months of use) by the principal investigator and self-administered by the patient daily. Saline solutions are labeled with non-identifiable codes to maintain blinding and are provided to the patients. Patients are instructed to rinse their mouth with 0.2% chlorhexidine solution for 30 seconds before use. They then apply the saline solution topically to the sites of oral gingivitis lesions twice daily. Patients are also trained to distribute the solution evenly across affected areas and to continue this process daily. They are instructed to avoid eating or drinking for 30 minutes after ap, CONDITION: L10.0 Pemphigus vulgaris. ; Pemphigus vulgaris, INCLUSION CRITERIA: Patients with biopsy-confirmed pemphigus vulgaris and diagnostic confirmation by a dermatologist. Patients with refractory gingivitis, defined as gingivitis with persistent symptoms (inflammation, bleeding, pain, or ulceration) despite standard treatment with systemic corticosteroids for at least 6 months. Age above1 years. Ability to provide written informed consent., PRIMARY OUTCOME: The primary outcome of this study is the change in the severity of treatment-resistant gingivitis in patients with pemphigus vulgaris, measured using the Pemphigus Oral Lesion Intensity Score (POLIS), developed by Sindhuja et al. in 2020. The POLIS questionnaire comprises 9 items categorized into three domains: 1) oral cavity-related symptoms (difficulty eating regular food based on dietary habits, difficulty eating food of varying consistencies such as raw solid, cooked solid, semi-solid, or liquid, difficulty brushing teeth, and restricted mouth opening), 2) symptoms related to other mucosal areas (difficulty swallowing and speaking), and 3) oral cavity examination (number of involved areas up to 11 sites, including hard palate, soft palate, oropharynx, tongue, floor of the mouth, upper and lower gums, upper and lower lip mucosa, and bilateral buccal mucosa; total size of ulcers/erosions measured with a ruler on a disposable wooden stick; and depth of ulcers/erosions classified as superficial or deep based on clinical judgment). Each item is scored from 0 (no issue/lesion) to 4 (very severe), with a total score ranging from 0 to 36, where a decrease in the POLIS score indicates improvement in gingivitis severity. The POLIS score is assessed at baseline, month 2, month 4, and month 6 (two months post-treatment) following the initiation of the intervention (topical insulin or placebo) in both groups. The POLIS questionnaire is completed by a trained dermatologist, with symptom-related items recorded via patient interviews and clinical examination items documented through direct inspection of the gums and measurement of ulcers. The POLIS questionnaire has high content validity (S-CVI=0.8) and convergent validity, with strong correlations with the ABSIS (r=0.85, p<0.001) and PDAI (r=0.70, p<0.001) scales. Its reliability is confirmed with a Cronbach’s alpha of 0.857, indicating good internal consistency, and inter-rater agreement is validated using the Bland-Altman plot. Timepoint: The POLIS score is assessed at baseline, month 2, month 4, and month 6 (two months post-treatment) following the initiation of the intervention (topical insulin or placebo) in both groups. Method of measurement: Pemphigus Oral Lesions Intensity Score(POLIS).