The objective of this randomized, double-blind clinical trial is evaluation of the effect of Finasteride microemulsion gel in the treatment of men with mild to moderate acne.
Design
In this study, 48 men with mild to moderate acne will be assigned into the study randomly and the subjects will be divided into two groups A and B randomly. Inclusion criteria of the study is male patients and patients with mild to moderate acne. Exclusion criteria of the study is topical or systemic 5α-reductase enzyme inhibitors drugs use; topical and systemic corticosteroids use; use of Isotretinoin over the past year; history of allergy to any topical or systemic drugs used.
Settings and conduct
Patients will be evaluated by a physician in terms of clinical manifestations of acne (number of lesions, acne severity, patient satisfaction). The two groups will be followed up for 3 months. Finasteride microemulsion gel twice in a day and 1% Clindamycin phosphate topical gel twice in a day will be administered for three months for group (A) and 1% Clindamycin phosphate topical gel twice in a day will be administered for three months for group (B). If any complications are detected, the patient will be excluded from the study. then two weeks, one month, and three months after the intervention will be followed up respectively.
Participants/Inclusion and exclusion criteria
Inclusion criteria of the study is male patients and patients with mild to moderate acne. Exclusion criteria of the study is topical or systemic 5α-reductase enzyme inhibitors drugs use; topical and systemic corticosteroids use; use of Isotretinoin over the past year; history of allergy to any topical or systemic drugs used.
Intervention groups
Finasteride microemulsion gel twice in a day and 1% Clindamycin phosphate topical gel twice in a day will be administered for three months for group (A) and 1% Clindamycin phosphate topical gel twice in a day will be administered for three months for group (B).
Main outcome variables
Patients will be examined for acne clinical examinations then two weeks, one month, and three months after the intervention will be followed up respectively.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160318027097N8
Registration date:2018-01-12, 1396/10/22
Registration timing:registered_while_recruiting
Last update:2018-01-12, 1396/10/22
Update count:0
Registration date
2018-01-12, 1396/10/22
Registrant information
Name
ِDr Faramarz Darghahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2000
Email address
mj.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-04-04, 1397/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effect of Finasteride microemulsion gel in the treatment of men with mild to moderate acne
Public title
Effect of Finasteride gel in the treatment of acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients; Patients with mild to moderate acne.
Exclusion criteria:
Age
From 10 years old to 70 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is simple, individual and using a random number table in this study. Patients who will admitted on odd days, will be assigned into group A and patients who will admitted on even days, will be assigned into group B. In this study, participants, researchers are unaware of prescription drugs.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, participants, researchers are unaware of prescription drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2017-09-20, 1396/06/29
Ethics committee reference number
IR.TBZMED.REC.1396.716
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70
ICD-10 code description
Acne
Primary outcomes
1
Description
The acne clinical manifestations
Timepoint
Befor the intervention, 2 weeks, 1 month, 3 months after the intervention
Method of measurement
Clinical examinations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Finasteride microemulsion topical gel, twice in a day and 1% Clindamycin phosphate topical gel, twice in a day for three months
Category
Treatment - Drugs
2
Description
Control group: 1% Clindamycin phosphate topical gel, twice in a day for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr Elham Nohchami
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 45 3351 2000
Email
naghizadeh73@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Street address
Vice chanscellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 45 3351 2006
Email
naghizadeh73@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mehdi Amirnia
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 45 3351 2000
Email
naghizadeh73@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Efat Khodayan
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 45 3351 2006
Email
naghizadeh73@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Elham Nohchami
Position
Dermatology Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 45 3351 2000
Email
naghizadeh73@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total potential data after unidentifiable individuals
When the data will become available and for how long
Start the access period from 2019
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
Data can be used for scientific and research studies.
From where data/document is obtainable
Dr Elham Nohchami; Dermatology Assistant; Naghizadeh73@yahoo.com
What processes are involved for a request to access data/document
After receiving the request email, data files will be sent in less than a week.