Therapeutic effect of 0.5% timolol eye drops on facial rosacea lesions in comparison with placebo in patients referred to the dermatology clinic of Razi Hospital and Imam Khomeini Hospital in Tehran in 2022 and 2023
Design
Clinical trial with control group, parallel groups, triple blind, randomized by block randomization, phase 2 clinical study, 2 groups of 22 people
Settings and conduct
The study includes 2 groups of 22 people.
After referring to the skin diseases and leprosy research center and taking the necessary measurements, according to the randomization table, the patients will receive one of the drugs of group a or b.
Patients, researchers and analysts do not know which drug group and which placebo group they are receiving. At the beginning of the study, 2 months after receiving the drug and one month after stopping the drug, the measurement of skin erythema and melanin, flushing, skin transparency and patient satisfaction will be checked and recorded using a questionnaire and Vizioface and Mexameter MX18 devices.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Have the criteria for the diagnosis of rosacea
Ability to visit at the appointed time and cooperate in taking medicine.
Not taking other drugs during the study.
Exclusion criteria:
History of heart problems and asthma.
Taking oral or topical medications such as antibiotics within 3 weeks before the study.
Pregnancy and breastfeeding
Intervention groups
we have 2 groups of 22 people. 1 group is given a placebo and 1 group is given drops of thymolol. Every night, 2 drops are used on each side of the face.
Patients are evaluated at the beginning of the visit and then 2 months after treatment and 1 month after stopping treatment.
Main outcome variables
erythema- flushing- side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220110053685N1
Registration date:2022-12-26, 1401/10/05
Registration timing:registered_while_recruiting
Last update:2022-12-26, 1401/10/05
Update count:0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
ali moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
dralimoradi20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of 0.5% thymolol eye drops on rosacea lesions of the face in comparison with placebo
Public title
The effect of timolol eye drops on rosacea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to cooperate to refer at the appointed time.
Ability to cooperate to necessary cooperation in taking the drug.
consciously understanding the consent and accepting its provisions.
agreeing not to breastfeed and pregnancy during the study and one month later in women of childbearing age.
willingness not to take other drugs during the study.
Have the criteria for diagnosing rosacea.
Exclusion criteria:
Receive any research medication within 30 days prior to enrollment.
history of allergy to beta-blocker,
pregnancy or attempt to conceive or breastfeed.
severe depression.
history of hypotension or bradycardia,
history of myocardial infarction or heart failure.
history of arrhythmia,
history of asthma or bronchospasm.
Taking any rosacea stimulant such as calcium channel blocker during the study.
taking alpha or beta blocker drugs.
not cooperating in the correct use of the drug or visiting at the appointed time.
specific exclusion criteria including taking oral or topical drugs such as antibiotics during 3 weeks before Study
criteria for excluding diagnostic biopsy including lidocaine allergy or a history of hypertrophic or colloidal scarring.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples to two experimental groups, the random block method (block randomization) has been used, considering blocks of 4, 6, and 8. An online software at https://www.sealedenvelope.com/simple-randomiser/v1/lists was used to generate a sequence of random numbers. In order to reproduce the randomization sequence, seed equal to 36821706636683 was used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The container containing the drug and placebo will be unlabeled, and all the containers will be similar and indistinguishable, and another person will give the desired drug to the patients based on the block order. The doctor, the patient, the person assessing the outcome and the person analyzing will not know the content of the drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Imam Khomeini Hospital Complex - Tehran University of Medical Scienc
Street address
taleqani street
City
tehran
Province
Tehran
Postal code
1416613675
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.356
Health conditions studied
1
Description of health condition studied
rosacea
ICD-10 code
L71
ICD-10 code description
Rosacea
2
Description of health condition studied
rosacea
ICD-10 code
T44.7X5
ICD-10 code description
Adverse effect of beta-adrenoreceptor antagonists
Primary outcomes
1
Description
Investigation of flushing based on Global Flushing Severity Score criteria.
Timepoint
At the beginning of the study, one month later and two months after the start of the treatment, one month after stopping the medication
Method of measurement
It is scored by the patient based on the Global Flushing Severity Score between 0-10
2
Description
Evaluation of erythema based on the Clinician Erythema Assessment Scale
Timepoint
At the beginning of the study, one month later and two months after the start of the treatment, one month after stopping the medication
Method of measurement
A number between 0 and 4 is given by the doctor based on the Clinician Erythema Assessment Scale
3
Description
evaluation of erythema based on Patient's self assessment criteria
Timepoint
At the beginning of the study, one month later and two months after the start of the treatment, one month after stopping the medication
Method of measurement
It is scored by the patient based on the Patient's self assessment criteria between 0-4
4
Description
evaluation of erythema based on the mx18 probe of the mexameter device
Timepoint
At the beginning of the study, one month later and two months after the start of the treatment, one month after stopping the medication
Method of measurement
mx18 probe of the mexameter device
Secondary outcomes
1
Description
Investigation of the side effects of 0.5% timolol maleate eye drops
Timepoint
At the beginning of the study, one month and two months after starting the treatment and one month after stopping the medication
Method of measurement
questionnaire
2
Description
Erythema relapse investigation after discontinuation of treatment based on the Clinician Erythema Assessment Scale
Timepoint
A month later, stop taking the medicine
Method of measurement
Doctor evaluation based on Clinician Erythema Assessment Scale between 0-4
Intervention groups
1
Description
Intervention group: Patients in the intervention group are given half percent timolol maleate eye drops from Sina Daru, and two drops of the solution are used on each side of the face once every night before going to bed. Then, patients will be evaluated for erythema, flushing, and side effects at the beginning of treatment and before treatment, one and two months later, and one month after stopping treatment.
Category
Treatment - Drugs
2
Description
Control group: patients are given a medicinal bottle containing distilled water and two drops of the solution are used on each side of the face once every night before going to bed. Then, patients will be evaluated for erythema, flushing, and side effects at the beginning of treatment and before treatment, one and two months later, and one month after stopping treatment.