Evaluation of the efficacy of cyclosporine cream 5% compared to metronidazole gel 0/75% in the treatment of rosacea: A randomized controlled clinical trial
Determination of the efficacy of cyclosporine cream compared with metronidazole gel in the treatment of rosacea
Design
A controlled, parallel, single-blinded, randomized, phase 2-3 clinical trial of 60 patients. Randomized with sealed envelopes.
Settings and conduct
In all patients, after collecting demographic and clinical data, the face is photographed and each patient is randomly assigned to one of the two groups mentioned above. The treatment period is three months, and the evaluation of the study results is performed by a dermatologist who blindly assesses the type of intervention after one, two, three, and five months after the start of treatment. Data analysis is also performed by a blinded statistician.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 15 to 50 years of age with a confirmed diagnosis of erythematotelangiectatic or papulopustular rosacea or a combination of both, the patient has not received treatment for their condition in the past two months, no serious underlying disease
Exclusion criteria: Occurrence of allergy or bacterial or viral disease during treatment or follow-up period
Intervention groups
1. Treatment with metronidazole gel 0.75% once per night
2. Treatment with 5% cyclosporine cream once per night
Main outcome variables
Evaluating the severity of the disease with the total severity score of rosacea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190901044666N2
Registration date:2022-12-05, 1401/09/14
Registration timing:registered_while_recruiting
Last update:2022-12-05, 1401/09/14
Update count:0
Registration date
2022-12-05, 1401/09/14
Registrant information
Name
Afsaneh Sadeghzadeh bazargan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2421
Email address
sadeghzadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-26, 1401/09/05
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of cyclosporine cream 5% compared to metronidazole gel 0/75% in the treatment of rosacea: A randomized controlled clinical trial
Public title
The effect of cyclosporine cream on rosacea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 15 to 50 years
Patients with a confirmed diagnosis of erythematotelangiectatic or papulopustular rosacea or a combination of both
The patient has not received treatment for his or her disease in the past two months
Absence of a serious underlying disease
Patient's cooperation in the implementation of therapeutic measures and participation in all therapeutic sessions
Exclusion criteria:
The occurrence of a sensitivity or adverse reaction to any of the therapeutic agents that prevents continuation of treatment
The occurrence of bacterial or viral skin disease during treatment or the follow-up period
Age
From 15 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After being selected by available method, patients are divided into two groups by simple randomization, so that among 60 sealed bags, one bag will be randomly selected for each patient. Each bag contains the letter a or b: a for metronidazole gel and b for cyclosporine cream
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation of the study results is performed by an evaluator blinded to the type of intervention (a dermatologist who does not know which treatment group the patient belongs to) and based on the images of the lesions taken in each session. Data analysis is also performed by a blinded statistician.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences, School of Medicine
Street address
School of Medicine, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.IUMS.FMD.REC.1401.431
Health conditions studied
1
Description of health condition studied
Erythematotelangiectatic or papulopustular rosacea
ICD-10 code
L71
ICD-10 code description
Rosacea
Primary outcomes
1
Description
Evaluating the severity of the disease
Timepoint
One, two, three and five months after starting treatment
Method of measurement
By the total severity score of rosacea
Secondary outcomes
1
Description
Doctor and patient satisfaction
Timepoint
One, two, three and five months after starting treatment
One, two, three and five months after starting treatment
Method of measurement
Examining the side effects of the treatment with a questionnaire
3
Description
tolerability
Timepoint
One, two, three and five months after starting treatment
Method of measurement
with the Investigator Assessment of Tolerability scale
Intervention groups
1
Description
Intervention group 1: Treatment with metronidazole gel 0.75% once per night for 3 months. For this purpose, the patient uses a thin layer of metronidazole gel locally on his/her erythematotelangiectatic or papulopustular lesions.
Category
Treatment - Drugs
2
Description
Intervention group 2: Treatment with cyclosporine cream 5% once a night for 3 months. For this purpose, the patient uses a thin layer of cyclosporine cream locally on his/her erythematotelangiectatic or papulopustular lesions.