CTRI/2026/07/113685Active, not recruitingPhase 3
A randomised controlled trial to compare efficacy of topical pilocarpine hydrogel 2 percent and triamcinolone acetonide oral paste 0.1 percent in the treatment of recalcitrant oral erosions in pemphigus vulgaris
DIPANKAR DE0 sites30 target enrollmentStarted: July 20, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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.
Arms & 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 inside oral mucosa. The timings are arbitrarily selected as 11 AM and 6 PM, timepoints away from mealtimes, when salivation is least likely to wash away the topically applied drug.
Intervention: 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 inside oral mucosa. The timings are arbitrarily selected as 11 AM and 6 PM, timepoints away from mealtimes, when salivation is least likely to wash away the topically applied drug.
Investigators
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