Health Condition 1: L100- Pemphigus vulgaris
Conditions
Interventions
Intervention1: Institutionally compounded topical pilocarpine hydrogel 2%: The patients will be instructed to apply topical pilocarpine 2% hydrogel twice daily on all the accessible refractory lesions
Sponsors
DIPANKAR DE
Eligibility
Inclusion criteria
Inclusion criteria: Patients with diagnosis of pemphigus vulgaris fulfilling the inclusion criteria listed below will be recruited for the study Refractory oral pemphigus vulgaris has been arbitrarily defined for present study as less than 75 percent reduction in the objective component of oral pemphigus disease area index after being treated with optimal systemic immunosuppression and topical corticosteroids for at least 6 months with lesions at sites accessible to topical application including retro-molar trigone, buccal mucosa, gingiva, palate and lips. Patients between 18 to 60 years. Patients who are willing to provide informed consent and willing for follow-up.
Exclusion criteria
Exclusion criteria: Patients younger than 18 years and older than 60 years will be excluded. Prior hypersensitivity or contraindication for topical pilocarpine or triamcinolone will be excluded. These will include presence of active fungal eg oral candidiasis, viral eg herpes simplex, or bacterial infections, post-surgical or traumatic ulcers, undiagnosed lesions to prevent masking of serious conditions eg oral cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the end of the study, the images will be archived, and the area representing the erosions will be measured using the imageJ software. For patients having involvement of more than one site (for example, resistant erosions on both gingiva), cumulative surface area of all erosions will be calculated.Timepoint: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective will be to compare the effect between the two groups on subjective improvement and quality of life as experienced by the patient [using visual acuity scoring (VAS) and oral health impact profile-14 (OHIP-14) scoring]. The effect of topical pilocarpine and topical triamcinolone treatment on the serological and salivary profile of anti-desmoglein 1 and 3 antibodies, and anti-acetylcholine receptor antibodies will also be assessed.Timepoint: Monthly for 3 months; salivary profile baseline and end of year | — |
Countries
India
Contacts
Public ContactDipankar De
Postgraduate Institute of Medical Education and Research (PGIMER)
Outcome results
None listed