To assess the effect of oral N-Acetylcysteine versus placebo on the severity of the clinical signs in patients with acne
Design
This is a double-blind randomized clinical trial, phase II, in which 90 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with acne who will refer to Sina Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 15 to 65 years;
Having acne
Exclusion criteria:
Pregnancy;
Using asteroid in the past three months;
Diabetes;
Hypercholesterolemia;
Renal or liver failure
Intervention groups
Intervention group: Capsule Doxycycline 100 mg twice a day for 8 weeks and ointment Clindamycin 1% or Benzyl peroxide 5% twice a day for 8 weeks and tablet N-Acetylcysteine 600 mg twice a day for 8 weeks
Control group: Capsule Doxycycline 100 mg twice a day for 8 weeks and ointment Clindamycin 1% or Benzyl peroxide 5% twice a day for 8 weeks and tablet placebo twice a day for 8 weeks
Main outcome variables
Primary outcome: Assessing the severity of clinical signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N226
Registration date:2018-07-01, 1397/04/10
Registration timing:prospective
Last update:2018-07-01, 1397/04/10
Update count:0
Registration date
2018-07-01, 1397/04/10
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral N-Acetylcysteine versus placebo on the severity of the clinical signs in patients with acne: a double-blind randomized clinical trial
Public title
Effect of oral N-Acetylcysteine versus placebo on the severity of the clinical signs in patients with acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15 to 65 years;
Having acne
Exclusion criteria:
Pregnancy;
Using asteroid in the past three months;
Diabetes;
Hypercholesterolemia;
Renal or liver failure
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.UMSHA.REC.1397.095
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
Assessing the severity of clinical signs
Timepoint
Before and 4 and 8 weeks after intervention
Method of measurement
Through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Capsule Doxycycline 100 mg twice a day for 8 weeks and ointment Clindamycin 1% or Benzyl peroxide 5% twice a day for 8 weeks and tablet N-Acetylcysteine 600 mg twice a day for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Capsule Doxycycline 100 mg twice a day for 8 weeks and ointment Clindamycin 1% or Benzyl peroxide 5% twice a day for 8 weeks and tablet placebo twice a day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Zhra Ahmadi
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
sunflower_4330@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Zhra Ahmadi
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
sunflower_4330@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Sobhan
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
mreza_sobhan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available