evaluation of clinical efficacy of topical formulation of Brimonidine and Ivermectin 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 15 patients with rosacea referring to dermatology clinic in Tehran in the year 1399 who want to participate in the study and complete the consent form are entered in the study. They receive topical cream brimonidine 0.5% /Ivermectin 1% 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/Ivermectin, 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.
Intervention groups
Intervention group: consumption of Brimonidine/ivermectin topical cream once a day for 8 weeks
Main outcome variables
severity of lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161207031288N7
Registration date:2021-01-31, 1399/11/12
Registration timing:registered_while_recruiting
Last update:2021-01-31, 1399/11/12
Update count:0
Registration date
2021-01-31, 1399/11/12
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
2020-11-21, 1399/09/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
preparation and clinical evaluation of combination of ivermectin and brimonidine topical formulation for treatment of rosacea
Public title
effect of ivermevectin and brimonidine combination in rosacea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having rosacea disease
treatment received in last three months
men and women over 18 years
Exclusion criteria:
More than 5 inflammatory acne lesions
Special forms of rosacea in addition to Dermatosis
Seborrheic dermatits
Acute lupus erythematosus
demodicosis
actinic telangiectasia
Hypersensitivity to brimonidine/Ivermectin
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
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 Islamic Azad Tehran Medical Sciences University_Pharmacy and Pharmaceutical of p
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419943471
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.IAU.PS.REC.1399.218
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/Ivermectin topical cream twice a day for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center For Research And Training In Skin Diseases And Leprosy