Effect of pilocarpine 2% eye drops on treatment resistant oral erosions of pemphigus.

Assessment of efficacy of topical pilocarpine 2% eye-drops in treatment of refractory/ persistent oral lesions of pemphigus vulgaris- a pilot study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010445

Enrollment

Registered

2017-11-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- recalcitrant oral ulcers of pemphigus vulgaris

Interventions

Intervention1: Pilocarpine: 2% pilocarpine eye drops 2 drops twice daily inside oral cavity, to be applied on the resistant oral erosions duration - 6 months Control Intervention1: not applicable: not

Eligibility

Inclusion criteria

Inclusion criteria: 2. Refractory oral PV, arbitrarily defined for present study as less than 75% reduction in ABSIS score after being treated with optimum systemic and topical treatment for 6 months; with lesions at sites accessible to topical pilocarpine application including retro-molar trigone, buccal mucosa, gingiva and palate. Twenty PV patients satisfying above-mentioned inclusion criteria will be recruited for this pilot study

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

Measure	Time frame
Secondary aim is to assess the effect of pilocarpine application on subjective improvement and quality of life as experienced by the patient (using VAS and OHIP-14 scoring).Timepoint: 6 months	—

Primary

Measure	Time frame
Primary aim of present study is to assess the efficacy and safety of topical pilocarpine 2% eye-drops (in terms of reduction in the size of erosions) in treatment of refractory/ persistent oral lesions of pemphigus vulgaris (PV) situated on buccal mucosa, retro-molar trigone, gingiva and palate. Also, measurement of anti desmoglein 1 and 3 antibodies will be done in both saliva and serum, at the time of inclusion in study and after completion of treatment.Timepoint: 6 months	—

Measure

Time frame

Primary aim of present study is to assess the efficacy and safety of topical pilocarpine 2% eye-drops (in terms of reduction in the size of erosions) in treatment of refractory/ persistent oral lesions of pemphigus vulgaris (PV) situated on buccal mucosa, retro-molar trigone, gingiva and palate. Also, measurement of anti desmoglein 1 and 3 antibodies will be done in both saliva and serum, at the time of inclusion in study and after completion of treatment.Timepoint: 6 months

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Countries

India

Contacts

Public ContactSanjeev Handa

PGIMER

handa_sanjeev@yahoo.com9815924777

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026