Pemphigus vulgaris. Pemphigus vulgaris
Conditions
Interventions
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
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Patients with gingivitis unrelated to pemphigus vulgaris. Patients with a history of hypersensitivity to insulin or its formulation components. Pregnant or breastfeeding patients. Patients with uncontrolled systemic diseases. Patients with active malignancy or chemotherapy treatment within the past 6 months. Patients unable to comply with regular follow-ups or unwilling to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 pl | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactTaha Shahbazi
Tehran University of Medical Sciences
Outcome results
None listed