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The effect of timolol eye drops on rosacea

Therapeutic effect of 0.5% thymolol eye drops on rosacea lesions of the face in comparison with placebo

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220110053685N1
Enrollment
44
Registered
2022-12-26
Start date
2022-01-15
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Condition 1: rosacea. Condition 2: rosacea. Rosacea Adverse effect of beta-adrenoreceptor antagonists

Interventions

Intervention 1: 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

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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.;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.;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.;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

MeasureTime frame
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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactali moradi

Tehran University of Medical Sciences

dralimoradi20@gmail.com+98 21 5563 0553

Outcome results

None listed

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