A Controlled clinical trial to compare the effet of Montelukast and placeboo on disease symptoms and process among 45-15 year old patients with mild to moderate acne
This study is a prospective clinical trial to compare the effect of Montelukast 5 mg chewable tablet with placebo, on acne course and severity in 40 patients with acne, who attend Razi Skin Hospital affiliated by Tehran University of Medical Sciences. This study is a double blinded study and participants' major inclusion criteria are patients with mild to moderate acne, being at the age of 15-45 year-old who have not received antibiotics and drugs for the treatment of acne within the last 3 months. Patients with the acne caused by endocrine diseases and ones with severe and scaring acne are excluded. Based on having the inclusion criteria, patients are included in the study and divided into two groups of intervention and control (20 patients in each group). Patients in intervention group will receive Montelukast 5mg chewable tablet and Acnomis cream (tretinoin 0.25% + clindamycin) once a day and patients in control group will receive Acnomis cream (tretinoin 0.25% + clindamycin) and Placebo chewable tablet once a day for 3 months. Acne severity will be evaluated in patients using Global Acne Severity Scale and will be documented with photography before starting the treatment and then after 1 month and 3 months. The side effects of drugs will also be evaluated in each visit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020632402N1
Registration date:2017-06-19, 1396/03/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-19, 1396/03/29
Registrant information
Name
Samane Moghanlou
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 0233
Email address
smoghanlou@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran University of Medical Science
Expected recruitment start date
2016-02-19, 1394/11/30
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Controlled clinical trial to compare the effet of Montelukast and placeboo on disease symptoms and process among 45-15 year old patients with mild to moderate acne
Public title
Montelukast effect in acne treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with acne; being at the age of 15-45 years old; using antibiotic and other acne treatments for less than 3 months. Exclusion criteria: age under 14 year-old and older than 45 year-old; indication for systemic retinoid treatment; nodulocystic acne (with scar formation possibility); antibiotic treatment for more than 3 months; Hormonal related acne(polycystic ovarian disease)
Age
From 15 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
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
4th Floor, No. 23, before Pour Sina St. - 16th Azad St. - Keshavarz Blvd
City
Tehran
Postal code
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1824
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Acne severity
Timepoint
Before treatment, 1 month and 3 months after treatment
Method of measurement
Acne global severity scale questionnaire
Secondary outcomes
1
Description
Drug Side effects
Timepoint
1 month and 3 months after the begining of treatment
Method of measurement
Asking patients
Intervention groups
1
Description
Intervention group: Treatment with Montelukast 5 mg chewable tablet, once a day plus tertinoin 0.25% +and clindamycin topical cream (acnomis) applied to the whole face once a day for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Treatment with placebo chewable tablet once a day plus tertinoin 0.25% +and clindamycin topical cream (acnomis) applied to the whole face once a day for 3 months.