Evaluation of the effectiveness of herbal products of Myrtus communis compared with Clindamycin 1% in reducing symptoms of Acne Vulgaris ,mild to moderate
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General information
3
N/A
3na
being 12–45 years old
facial acne vulgaris, mild to moderate ( having 20-140 total lesion count, 10-90 noninflammatory facial lesions, 10-50 inflammatory lesions, without facial nodular cystic lesion)
Being 12–45 years old
Facial acne vulgaris, mild to moderate ( Having 20-140 total lesion count, 10-90 noninflammatory facial lesions, 10-50 inflammatory lesions, without facial nodular cystic lesion)
beingBeing 12–45 years old facialFacial acne vulgaris, mild to moderate ( havingHaving 20-140 total lesion count, 10-90 noninflammatory facial lesions, 10-50 inflammatory lesions, without facial nodular cystic lesion)
have a skin disease that might interfere with the diagnosis or evaluation of their skin lesions
severe systemic disease
pregnant and lactating women
use of topical anti acne therapy two months before or during the study
use of oral retinoids six months before the study
known allergy or sensitivity to any of the study medications or their components
incidence of side effects
Unwillingness to continue this study
Unable to follow up the patient regularly
Have a skin disease that might interfere with the diagnosis or evaluation of their skin lesions
Severe systemic disease
Pregnant and lactating women
Use of topical anti acne therapy two months before or during the study
Use of oral retinoids six months before the study
known allergy or sensitivity to any of the study medications or their components
Incidence of side effects
Unwillingness to continue this study
Unable to follow up the patient regularly
haveHave a skin disease that might interfere with the diagnosis or evaluation of their skin lesions severeSevere systemic disease pregnantPregnant and lactating women useUse of topical anti acne therapy two months before or during the study useUse of oral retinoids six months before the study known allergy or sensitivity to any of the study medications or their components incidenceIncidence of side effects Unwillingness to continue this study Unable to follow up the patient regularly
Primary outcomes
#1
Total lesion count
Total lesion Count
Total lesion countCount
counting the comedones, papules and pustules
Counting the Comedones, Papules and Pustules
countingCounting the comedonesComedones, papulesPapules and pustulesPustules
#2
Speed of onset of treatment(The mean time to a 50% reduction in cal-culated total lesion scores) in every half of the face
Speed of onset of treatment(The mean time to a 50% reduction in acne lesion ) in every half of the face
Speed of onset of treatment(The mean time to a 50% reduction in cal-culated totalacne lesion scores) in every half of the face
سرعت شروع درمان (زمان کاهش 50 درصد از تعداد کامل ضایعات اکنه ) در هر نیمه صورت
سرعت شروع درمان (زمان کاهش 50 درصد ضایعات اکنه) در هر نیمه صورت
سرعت شروع درمان (زمان کاهش 50 درصد از تعداد کامل ضایعات اکنه) در هر نیمه صورت
at the end of the sixth and twelfth week
At the end of the sixth and twelfth week
atAt the end of the sixth and twelfth week
counting the comedones, papules and pustules
Index of Severity of Acne=ASI Total lesion Count = TLC
counting the comedones, papules and pustulesIndex of Severity of Acne=ASI Total lesion Count = TLC
شمارش کومدونها،پاپولها و پوستولها
شمارش کلی ضایعات=TLCواندکس شدت آکنه=ASI
شمارش کومدونها،پاپولها و پوستولهاکلی ضایعات=TLCواندکس شدت آکنه=ASI
#3
index of severity of acne=ASI Total lesion count = TL
Index of Severity of Acne=ASI Total lesion Count = TLC
indexIndex of severitySeverity of acneAcne=ASI Total lesion countCount = TLTLC
Secondary outcomes
#1
at the end of the sixth, twelfth and sixteenth week of the study
At the end of the sixth, twelfth and sixteenth week of the study
atAt the end of the sixth, twelfth and sixteenth week of the study
common terminology criteria for Adverse Evently v4.02009
Common terminology criteria for Adverse Evently v4.02009
commonCommon terminology criteria for Adverse Evently v4.02009
بر اساس کرایتریاهای common terminology criteria for Adverse Evently v4.02009
بر اساس کرایتریاهای Common terminology criteria for Adverse Evently v4.02009
بر اساس کرایتریاهای commonCommon terminology criteria for Adverse Evently v4.02009
#2
before intervention and 16 weeks after the beginning of intervention
Before intervention and 16 weeks after the beginning of intervention
beforeBefore intervention and 16 weeks after the beginning of intervention
#3
melanin
Melanin
melaninMelanin
mexameter
Mexameter
mexameterMexameter
#4
patient satisfaction
Patient satisfaction
patientPatient satisfaction
at the end of twelfth week
At the end of twelfth week
atAt the end of twelfth week
#5
at the end of the sixth, twelfth and sixteenth week of the study
At the end of the sixth, twelfth and sixteenth week of the study
atAt the end of the sixth, twelfth and sixteenth week of the study
#6
at the end of the sixth, twelfth and sixteenth week of the study
At the end of the sixth, twelfth and sixteenth week of the study
atAt the end of the sixth, twelfth and sixteenth week of the study
Protocol summary
Study aim
The purpose of this study is to determine the anti acne effect of Myrtus commmunis formulation versus clindamycine 1% . the practical purpose of it is to introduce an effective drug with low side effects for treatment of acne based on iranian medicine.
Design
The study population are selected from the patients who have inclusion criteria and referred to traditional medicine clinic of Ahmadiyeh, traditional medicine clinic of Behesht or Skin and Stem Cell Research Center , after filling consent form.
The sample size is 55 people. The study will be designed in a bilateral form and the the Myrtus communis formulation will be applied on one side of the face and the clindamycin1% will be applied on the other side for three months. The number and severity of skin lesions will be counted and evaluated within the defined periods of the treatment (at the end of the sixth, twelfth and sixteenth week of the treatment) which is expected to be decreased
Settings and conduct
The study will be designed in split face. Myrtus communis formulation will be applied on one side of the face and the clindamycin1% will be applied on the other side for 12 weeks. The number and acne severity index will be counted and evaluated within the defined periods of the treatment (at the end of the sixth, twelfth and sixteenth week of the treatment). The place of study is in the traditional medicine clinic of Ahmadiyeh and Behesht or Skin and Stem Cell Research Center.
Participants/Inclusion and exclusion criteria
12–45 years old, facial acne vulgaris, mild to moderate
Intervention groups
Intervention group: Myrtus communis topical formulation two times a day in one side of the face for 12 weeks
Control group: Clindamycin1% solution two times a day in another side of the face for 12 weeks
Main outcome variables
number and acne severity index
side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171122037581N1
Registration date:2018-01-02, 1396/10/12
Registration timing:registered_while_recruiting
Last update:2019-09-05, 1398/06/14
Update count:3
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
Mahboobeh Salmanian haji agha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 9724
Email address
salmanian.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
2017-12-06, 1396/09/15
Actual recruitment end date
2019-07-04, 1398/04/13
Trial completion date
2019-07-04, 1398/04/13
Scientific title
Evaluation of the effectiveness of herbal products of Myrtus communis compared with Clindamycin 1% in reducing symptoms of Acne Vulgaris ,mild to moderate
Public title
Myrtus communis effect in acne treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being 12–45 years old
Facial acne vulgaris, mild to moderate ( Having 20-140 total lesion count, 10-90 noninflammatory facial lesions, 10-50 inflammatory lesions, without facial nodular cystic lesion)
Exclusion criteria:
Have a skin disease that might interfere with the diagnosis or evaluation of their skin lesions
Severe systemic disease
Pregnant and lactating women
Use of topical anti acne therapy two months before or during the study
Use of oral retinoids six months before the study
known allergy or sensitivity to any of the study medications or their components
Incidence of side effects
Unwillingness to continue this study
Unable to follow up the patient regularly
Age
From 12 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
55
More than 1 sample in each individual
Number of samples in each individual:
2
right and left side of the face
Actual sample size reached:
48
More than 1 sample in each individual
Actual sample size in each individual:
2
right and left side of the face
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will receive two drug containers with the same shape and size but different content. each patient instructed to use antiacne1 on right side of the face and antiacne 2 on the left side. the patiant, the physician who will examine the patients and appraiser of them will not be aware of the contents of the drug containers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9321309010
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
Total lesion Count
Timepoint
At the beginning of the study and at the end of the sixth, twelfth and sixteenth week of the study
Method of measurement
Counting the Comedones, Papules and Pustules
2
Description
Severity of Acne
Timepoint
At the beginning of the study and at the end of the sixth, twelfth and sixteenth week of the study
Method of measurement
Acne Severity Index
3
Description
Speed of onset of treatment(The mean time to a 50% reduction in acne lesion ) in every half of the face
Timepoint
At the end of the sixth and twelfth week
Method of measurement
Index of Severity of Acne=ASI Total lesion Count = TLC
4
Description
Recurrence
Timepoint
4 weeks after treatment
Method of measurement
Index of Severity of Acne=ASI Total lesion Count = TLC
Secondary outcomes
1
Description
Side effects
Timepoint
At the end of the sixth, twelfth and sixteenth week of the study
Method of measurement
Common terminology criteria for Adverse Evently v4.02009
2
Description
Skin erythema
Timepoint
Before intervention and 16 weeks after the beginning of intervention
Method of measurement
Mexameter
3
Description
Skin hydration
Timepoint
At the beginning of the study and the end of sixteenth week of the study
Method of measurement
Corneometer
4
Description
Change in sebum production
Timepoint
At the beginning of the study and the end of sixteenth week of the study
Method of measurement
Sebumeter
5
Description
Acne lesion and presence of Propionibacterium acnes bacteria
Timepoint
At the beginning of the study and the end of sixteenth week of the study
Method of measurement
Visiopor
6
Description
Melanin
Timepoint
At the beginning of the study and the end of sixteenth week of the study
Method of measurement
Mexameter
7
Description
Patient satisfaction
Timepoint
At the end of twelfth week
Method of measurement
questionnaire
8
Description
Evaluation of drug tolerance by the patient on each side of the face(burning, pruritus)
Timepoint
At the end of the sixth, twelfth and sixteenth week of the study
Method of measurement
questionnaire
9
Description
Evaluation of drug tolerance by the physician on each side of the face(erythema, dryness, peeling)
Timepoint
At the end of the sixth, twelfth and sixteenth week of the study
Method of measurement
examination
Intervention groups
1
Description
Intervention group: the Myrtus communis topical formulation will be applied on one side of the face two times a day for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: the clindamycin1% will be applied on the other side of the face for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahmadieh traditionale clinic
Full name of responsible person
Lila Shirbeigi
Street address
North Sarparast Street, Palestine Square
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 6527
Email
salma.ms219@gmail.com
2
Recruitment center
Name of recruitment center
Behesht traditional clinic
Full name of responsible person
Effat Jafari Dehcordi
Street address
847, Behest Street, Vahdat Islami Street,Hassan abad Square
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5515 2191
Email
stm@iums.ac.ir
3
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center
Full name of responsible person
Parvin Mansouri
Street address
Tehran Province, Tehran, No 4 Maryam Dead End South Andarzgo Blvd, Kamraniyeh
City
Tehran
Province
Tehran
Postal code
19379511
Phone
+98 21 2220 1710
Email
tmarkaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakooti
Street address
Iran University of Medical Sciences, Besides Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Mahboobah Salmanian Haji Agha
Position
PhD Student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 5563 9724
Email
salma.ms219@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahboobah Salmanian Haji Agha
Position
PhD Student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5515 2192
Email
salma.ms219@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahboobeh Salmanian haji agha
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9724
Fax
Email
salma.ms219@gmail.com
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