efficacy of oral probiotic with doxycyclin in comparison with doxycyclin in acne vulgaris
Design
This study is designed as randomized double blinded in the year of 2019-2020. 100 patients from Rasool Akram hospital with age between 18 to 35 with Moderate acne (grade 2 or 3 of global acne assessment scale with totally 20 to 50 inflammatory lesion ) randomly will divide with Excel software into 50 equal control and intervention group.
Settings and conduct
patients will chosen from 100 sealed envelops for any patient with equal code A or B from a box. just the principle investigator knows about patient and no one else dont know about any code or treatment plan.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patient with Moderate acne (grade 2 or 3 of global acne assessment scale with totally 20 to 50 inflammatory lesion )
people with age between 18 to 35
exclusion criteria :
Pregnant or Breast feeding female patient
Receiving antibiotics in last months
Patient with dyspepsia
Intervention groups
all of patients will treat with antibacterial shampoo and Adapalen cream as uniform topical treatment. control group receive doxycycline capsule daily. the intervention group receive doxycycline capsule plus probiotic capsule daily. All of patients acne lesions will photographed with digital camera before treatment and one , two and three months after treatments. treatment response will assess with global acne grading and acne severity index
Main outcome variables
treatment response will assess with global acne grading and acne severity index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190830044645N1
Registration date:2019-10-01, 1398/07/09
Registration timing:registered_while_recruiting
Last update:2019-10-01, 1398/07/09
Update count:0
Registration date
2019-10-01, 1398/07/09
Registrant information
Name
Masoumeh Mohamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4445 3955
Email address
mohamadi11248@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
efficacy of oral probiotic with doxycyclin in comparison with doxycyclin in acne vulgaris
Public title
ٍEfficacy of oral Probiotic with Doxycyclin in comparison with Doxycyclin in Acne Vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with Moderate acne (grade 2 or 3 of global acne assessment scale with totally 20 to 50 inflammatory lesion )
people with age between 18 to 35
Exclusion criteria:
Pregnant or Breast feeding female patient
Receiving antibiotics in last months
Patient with dyspepsia
Age
From 18 years old to 35 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients enter the treatment groups on a 1: 1 ratio using Excel software. From a box with 100 sealed envelopes, each patient is selected with one envelope containing either A or B. (Method I: A and Method II: B)
Blinding (investigator's opinion)
Double blinded
Blinding description
just the principle investigator knows about patient and no one else dont know about any code or treatment plan.
Patients in the intervention and control groups did not know which treatment group they entered. These patients are not aware of the type of treatment group that they enter. Both groups receive standard and identical treatment. The intervention group uses probiotic capsule in addition to standard treatment. The control group received only standard treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences Ethics Committee
Street address
Satarkhan street , Niyayesh Avenue , Rasool Akram hospital , Dermatology Department Office
City
Tehran
Province
Tehran
Postal code
1469935947
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.IUMS.FMD.REC.1398.130
Health conditions studied
1
Description of health condition studied
Acne Vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
acne grading in global acne grading and acne severity index
Timepoint
before intervention, one , two and three months after treatment
Method of measurement
global acne grading and acne severity index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients will treat with antibacterial shampoo and Adapalen cream as uniform topical treatment. The intervention group receive doxycycline capsule plus probiotic capsule daily. All of patients acne lesions will photographed with digital camera before treatment and one , two and three months after treatments. treatment response will assess with global acne grading and acne severity index
Category
Treatment - Drugs
2
Description
Control group:patients will treat with antibacterial shampoo and Adapalen cream as uniform topical treatment. control group receive only doxycycline capsule dailyand do not receive d probiotic capsule. All of patients acne lesions will photographed with digital camera before treatment and one , two and three months after treatments. treatment response will assess with global acne grading and acne severity index
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Masoumeh Mohamadi
Street address
Satarkhan street , Niyayesh Avenue , Rasool Akram hospital , Dermatology Department Office
City
Tehran
Province
Tehran
Postal code
1469935947
Phone
+98 21 6435 2528
Email
mohamadi11248@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Doctor Seyed Abbas Motavallian
Street address
Iran University of Medical Sciences , near Milad Tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Masoumeh Mohamadi
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Rasool akram hospital
City
Tehran
Province
Tehran
Postal code
1469935947
Phone
+98 21 4445 3955
Fax
Email
mohamadi11248@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoumeh Mohamadi
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Rasool akram hospital
City
Tehran
Province
Tehran
Postal code
1469935947
Phone
+98 21 4445 3955
Fax
Email
mohamadi11248@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoumeh Mohamadi
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Rasool akram hospital
City
Tehran
Province
Tehran
Postal code
1469935947
Phone
+98 21 4445 3955
Fax
Email
mohamadi11248@gmail.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
all collected deidentified IPD to be shared
When the data will become available and for how long
starting after publication
To whom data/document is available
our data is available for researchers.
Under which criteria data/document could be used
data for analysis and usage in research programs can be use , but he should confirm the data is belong to us.
From where data/document is obtainable
contact email : mohamadi11248@gmail.com
What processes are involved for a request to access data/document