The aim is to investigate the effect of pilocarpine drop as a cholinomimetic on recalcitrant mouth lesions caused by pemphigus vulgaris and its usage as a future medication.
Design
This is a single-blinded, randomized, controlled trial. this phase 2-3 trial will be parallelly performed on 42 patients.
Settings and conduct
Forty-two patients with recalcitrant mouth lesions referred to the pemphigus clinic at Razi Hospital located in Tehran enter the study. Patients are randomly and equally divided into 2 groups of treatment and placebo and will receive the drug or placebo simultaneously. This study is single-blinded, and none of the patients are informed about the received treatment(pilocarpine or placebo).
Participants/Inclusion and exclusion criteria
The patients diagnosed with pemphigus vulgaris clinically and histo-pathologically are involved with resistant mouth lesions, age 20-70, and involved mouth lesions should not be more than 2-3 in each patient.
Intervention groups
Two groups of intervention and control in this study have been randomly assigned. The intervention group receives drop pilocarpine 4%, and the placebo group receives distilled water as placebo.
Main outcome variables
Evaluating the oral lesions by oral disease severity score (ODSS); assessing the patient satisfaction by visual analogue scale (VAS); evaluating the disease activity by pemphigus area disease activity (PDAI); measuring the size of lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221002056070N1
Registration date:2023-11-25, 1402/09/04
Registration timing:prospective
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Nafiseh Esmaili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5557 5141
Email address
esmaelin@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of topical pilocarpine as a cholinomimetic on refractory oral lesions :a single blinded, randomized controlled trial
Public title
The effect of drop pilocarpine on oral lesions in pemphigus vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical and histopathological confirmation of pemphigus vulgaris
Patients with resistant oral ulcers that have not been treated with systemic drugs or have relapsed after treatment
Age between 20-70
Accessible mouth lesions(retromolar trigone)
Exclusion criteria:
oral lesions more than 2-3
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned into two groups: A( drug) and B( placebo). Block randomization with size of four will be used via random allocation software. To produce a list of random numbers, a number is made by the software. If the number is between 0 and 4, the patients will be allocated to group B. If the number is between 5 and 9 the patient will be placed in group A. The process will be repeated until the eligible patients are included.
Blinding (investigator's opinion)
Single blinded
Blinding description
The drug and placebo (pilocarpine and distilled water) have the same form and are given in the same containers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tehran University of medical science
Street address
Razi Hospital, vahdat eslami square, vahdat eslami avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1199663911
Approval date
2022-09-10, 1401/06/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.446
Health conditions studied
1
Description of health condition studied
pemphigus vulgaris oral lesions
ICD-10 code
L10.0
ICD-10 code description
Pemphigus vulgaris
Primary outcomes
1
Description
size of oral lesions
Timepoint
Baseline visit, week 4 and week 8
Method of measurement
Measuring the size of lesions in photos by software, evaluation of patient satisfaction, oral lesion status and disease severity using VAS, ODSS and PDAI questionnaires
Secondary outcomes
1
Description
Pemphigus disease area index (PDAI)
Timepoint
Baseline visit and week 8
Method of measurement
Pemphigus disease area index questionnaire (PDAI)
Intervention groups
1
Description
Intervention group: The drug used in this group is drop pilocarpine 4%, which is put in another container to avoid getting identified by the patients. Patients will be using the drug for 8 weeks, twice a day (morning and afternoon). The drug administration will be done via a smeared cotton swab.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive distilled water in the same containers as the intervention group. The process is also done the same as the intervention group (within 8 weeks, twice a day and two drops).