Prednisolone maintenance therapy in pemphigus vulgaris.

Comparison of the efficacy and side effects of low dose (=10 mg/day) prednisolone maintenance therapy in pemphigus Vulgaris patients on remission with minimal prednisolone therapy and positive anti-desmoglein 1 and/or 3 antibodies referring to Razi Hospital, Tehran, Iran in 2020.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190813044524N1

Enrollment

Registered

2020-04-20

Start date

2020-04-27

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

Pemphigus vulgaris. Pemphigus vulgaris

Interventions

Intervention 1: Intervention group: Group 1: Pemphigus Vulgaris patients with mild disease at diagnosis, who are on remission with prednisolone minimal therapy (=10 mg/day which is used as 1or 2 table

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pemphigus vulgaris patients on remission phase. Under treatment with low dose prednisolone (5-10 mg/day) maintenance therapy. Positive anti-desmogleion 1 and/or 3.

Exclusion criteria

Exclusion criteria: Pemphigus vulgaris patients with negative anti-desmogleion. Active phase of the disease

Design outcomes

Primary

Measure	Time frame
Continuation of the remission phase of the disease. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: Direct examination by the a dermatologist so that the patient has no skin and/or mucosal manifestations.	—

Secondary

Measure	Time frame
Increase in infection rate. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: Question about history of the fever, loss of consciousness, headache, shortness of breath, cough, sore throat, abdominal pain, diarrhea and vomiting, dysuria and frequency, abnormal vaginal discharge, redness and warmth of the skin and record information in the patient's file by the physician.;Weight gain. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: The patient's weight is measured with the center scale and recorded in the patient's file by the physician.;Cataract. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: The question of blurred vision and its severity, if the answer is yes, we will refer her to an ophthalmologist to determine the extent of the conflict (Farabi Hospital).record information in the patient's file based on the sheet provided by the ophthalmologist by the researcher physician.;Diabetes. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: Measurement of blood sugar over the past 3 month (HbA1C) and fasting blood sugar (FBS) and record information in the patient's file by the doctor.;Osteoporosis. Timepoint: Before starting the study, End of the first year. Method of measurement: Perform bone mineral densitometry and record information in the patient's file by the physician.	—

Measure

Time frame

Increase in infection rate. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: Question about history of the fever, loss of consciousness, headache, shortness of breath, cough, sore throat, abdominal pain, diarrhea and vomiting, dysuria and frequency, abnormal vaginal discharge, redness and warmth of the skin and record information in the patient's file by the physician.;Weight gain. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: The patient's weight is measured with the center scale and recorded in the patient's file by the physician.;Cataract. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: The question of blurred vision and its severity, if the answer is yes, we will refer her to an ophthalmologist to determine the extent of the conflict (Farabi Hospital).record information in the patient's file based on the sheet provided by the ophthalmologist by the researcher physician.;Diabetes. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: Measurement of blood sugar over the past 3 month (HbA1C) and fasting blood sugar (FBS) and record information in the patient's file by the doctor.;Osteoporosis. Timepoint: Before starting the study, End of the first year. Method of measurement: Perform bone mineral densitometry and record information in the patient's file by the physician.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Mahmoudi

Tehran University of Medical Sciences

hr_mahmoody@yahoo.com+98 21 5563 0553

Outcome results

None listed

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