evaluation of clinical efficacy of topical formulation of Brimonidine on Rosacea disease
Design
Phase II single group. before -after, clinical study
Settings and conduct
This interventional study is performed as a before-after clinical trial in Center for Education and Research of Dermatology and Leprosy, Tehran University of Medical Sciences. A total of 20 patients with rosacea referring to dermatology clinic in Tehran in the year 1395 who want to participate in the study and complete the consent form are entered in the study. They receive topical gel brimonidine 0.5 once daily for 8 weeks. The rate of healing is evaluated 4 and 8 weeks after treatment; more over the observed side-effects are recorded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with acne rosacea who have not received treatment in the last three months. Men and women over 18 years, clinical diagnosis of facial rosacea score 4 based on Patient Self-Assessment (PSA) or score >=3 based on Clinician Erythema Assessment (CEA).
Exclusion Criteria: severe side-effects and hypersensitivity to brimonidine, those who have more than 5 inflammatory lesions (papule or pustule), Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia, Previous treatment with Brimonidine gel 33% or any other Brimonidine Tartarate formulated treatment on rosasea erythema four weeks before entering the study.
Intervention groups
Intervention group: patients with Acne Rosacea who receive Brimonidine topical gel twice a day for 8 weeks
Main outcome variables
Significant improvement in severity of lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161207031288N4
Registration date:2019-01-27, 1397/11/07
Registration timing:retrospective
Last update:2019-01-27, 1397/11/07
Update count:0
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
Saman Ahmad Nasrollahi
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 8190
Email address
snasrollahi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-10-15, 1396/07/23
Actual recruitment end date
2018-02-21, 1396/12/02
Trial completion date
2018-05-30, 1397/03/09
Scientific title
Safety and efficacy assessment of Brimonidine topical formulation on rosacea disease
Public title
Effect of Brimonidine on rosacea disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having rosacea disease
No treatment received in last three months
Exclusion criteria:
More than 5 inflammatory acne lesions
Special forms of rosacea in addition to Dermatosis
Acute Lupus erythematosus
Previous treatment with Brimonidine gel 33%
Seborrheic dermatits
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-04-15, 1396/01/26
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2072
Health conditions studied
1
Description of health condition studied
Rosacea
ICD-10 code
L71
ICD-10 code description
Rosacea
Primary outcomes
1
Description
severity of lesions according to and Clinician Erythema Assessment (CEA)
Timepoint
Before treatment and 4 and 8 weeks later
Method of measurement
Physical exam
Secondary outcomes
1
Description
Severity of lesions according to Patient Self-Assessment (PSA)
Timepoint
Before treatment and 4 and 8 weeks later
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Brimonidine topical gel twice a day for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Pharmaceutical, Cosmeceutical and Hygienic Skin Products Clinical Evaluation Unit (DermaLab) cen