comparison between the efficacy of intralesional rituximab and intralesional triamcinolone in the treatment of patients with refractory pemphigus vulgaris
Pemphigus Vulgaris (PV) is an autoimmune vesiculobullos disease characterized by autoantibody against cellular adhesion molecules. The mainstay of treatment is corticosteroid therapy, but sometimes there is resistance to corticosteroids or dependency to them which is associated with many side effects. Thus attempts to find other more safe and effective options for treating resistant patients are to be continued. Our purpose is to evaluate the efficacy of this modality versus another similar modality.
Design
blinded randomized clinical trial with a parallel group design on 21 patients, enrolled between October 2017 and November 2018, and followed for six mounths.
Settings and conduct
Study was done on the patients coming to the dermatology clinic of Alzahra hospital in Isfahan. At the first visit after initial measurements drugs were injected and patients come back after one mounths, then measurements were done again and drugs were reinjected. Then patient were visited mounthly for another 4 mounths. Patients and pesons who inject the drug were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Lack of responses to oral immunosuppressive treatment after 4-month
2-Non-infective lesions
3-The nonexistence of rituximab contraindication
Excluding criteria:
Allergic reaction and infection after rituximab injection
Intervention groups
Lesions treated with intralesional rituximab
Lesions treated with intralesional triamcinolone
Main outcome variables
Percentage of changes in size of the lesions
PVLS Score
VAS
Epithelialization Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042105N1
Registration date:2019-01-01, 1397/10/11
Registration timing:retrospective
Last update:2019-01-01, 1397/10/11
Update count:0
Registration date
2019-01-01, 1397/10/11
Registrant information
Name
Farzaneh Danesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3264 3327
Email address
fdanesh2005@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
2017-11-25, 1396/09/04
Actual recruitment end date
2018-11-21, 1397/08/30
Trial completion date
2018-11-21, 1397/08/30
Scientific title
comparison between the efficacy of intralesional rituximab and intralesional triamcinolone in the treatment of patients with refractory pemphigus vulgaris
Public title
intralesional rituximab in pemphigus vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with refractory lesions of pemphigus vulgaris in the scalp and oral cavity after 4 mounths of systemic therapy
No contraindication for rituximab
Exclusion criteria:
Any contraindication for rituximab
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Two lesions with same size and in the same anatomic area(both on the scalp or in the oral cavity) from each patient will be selected.
Actual sample size reached:
21
More than 1 sample in each individual
Actual sample size in each individual:
2
Two lesions with same size and in the same anatomic area(both on the scalp or in the oral cavity) from each patient were selected.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization has benn used with individual unit.It means from each patient we select two lesions with same properties ( size and anatomic location ) and after coin tossing we inject rituximab in one lesion and triamcinolone in another one. But the patient and person who injects thedrug do not know each lesion is treated with which drug.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and person who injects thedrug do not know each lesion is treated with which drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
No.1/61, Abolhasan Esfahani Ave, Moshtagh Blv.
City
Isfahan
Province
Isfehan
Postal code
8157637383
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
396599
Health conditions studied
1
Description of health condition studied
pemphigus vulgaris
ICD-10 code
L10.0
ICD-10 code description
Pemphigus vulgaris
Primary outcomes
1
Description
Percentage of size variation in pemphigus lesions
Timepoint
Measurement of size of the lesions on day 1 and 30 and then mounth6.
Method of measurement
Ruler and medical thermometer
Secondary outcomes
1
Description
Visual Analogue Scale
Timepoint
day 0 and 30 and then mounth6.
Method of measurement
Asking from patient
Intervention groups
1
Description
Intervention group 1: 1cc intralesional ritumab10 mg/ml will be injected in 21 lesions and after one month will be repeated.
Category
Treatment - Drugs
2
Description
Intervention group 1: 1cc intralesional triamcinolone10 mg/ml will be injected in 21 lesions and after one month will be repeated.