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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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History
# Registration date Revision Id
4 2019-08-10, 1398/05/19 102555
3 2019-06-22, 1398/04/01 98294
2 2018-01-16, 1396/10/26 37090
1 2018-01-02, 1396/10/12 31708
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  • Protocol summary

    The purpose of this study is to determine the antiacne effect of Myrtus commmunis formulation versus clindamycine 1% and the practical purpose of it is to introduce an effective drug with low side effects for treatment of acne based on Iranian traditional medicine.
    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.
    هدف از انجام این مطالعه، تعیین اثر فرمولاسیون " مورد " در مقایسه با کلیندامایسین 1% در درمان اکنه است. و هدف کاربردی ان معرفی دارویی موثر با عوارض کم بر مبنای طب سنتی ایرانی برای درمان اکنه است..
    هدف از انجام این مطالعه، تعیین اثر فرمولاسیون " مورد " در مقایسه با کلیندامایسین 1% در درمان اکنه است. و هدف کاربردی ان معرفی دارویی موثر با عوارض کم بر مبنای طب ایرانی برای درمان اکنه است..
    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). The place of study is in the traditional medicine clinic of Ahmadiyeh, traditional medicine clinic of Behesht or Skin and Stem Cell Research Center.
    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.
    مطالعه بصورت دوطرفه انجام می شود و در یک سمت صورت بیمار از فرمولاسیون" مورد " و در سمت دیگر از کلیندامایسین 1% به مدت سه ماه استفاده خواهد شد. بدین منظور تعداد و شدت ضایعات پوستی بیماری آکنه در بازه های زمانی مشخصی از درمان (پایان هفته ششم، دوازدهم و شانزدهم ) بررسی می گردد .محل انجام مطالعه سلامتکده طب سنتی احمدیه،سلامتکده طب سنتی بهشت و مرکز تحقیقات پوست و سلولهای بنیادی است
    مطالعه بصورت دوطرفه انجام می شود. در یک سمت صورت بیمار از فرمولاسیون" مورد " و در سمت دیگر از کلیندامایسین 1% به مدت12هفته استفاده خواهد شد. بدین منظور تعداد و شدت ضایعات پوستی بیماری آکنه در بازه های زمانی مشخصی از درمان (پایان هفته ششم، دوازدهم و شانزدهم ) بررسی می گردد .محل انجام مطالعه سلامتکده طب سنتی احمدیه،سلامتکده طب سنتی بهشت و مرکز تحقیقات پوست و سلولهای بنیادی است
    being 12–45 years old, having facial acne vulgaris, mild to moderate
    12–45 years old, facial acne vulgaris, mild to moderate
    سن 12 تا 45 سال با اکنه وولگاریس خفیف تا متوسط روی صورت
    سن 12 تا 45 سال اکنه وولگاریس خفیف تا متوسط روی صورت
    number and severity of skin lesions side effects
    number and acne severity index side effects
    تعداد و شاخص شدت ضایعات پوستی عوارض جانبی
    تعداد و شاخص شدت اکنه عوارض جانبی

  • General information

    empty
    48
    No
    Yes
    empty
    2
    empty
    2017-12-06, 1396/09/15
    empty
    2019-07-04, 1398/04/13
    empty
    2019-07-04, 1398/04/13
    empty
    empty
    empty
    right and left side of the face
    empty
    نیمه راست و چپ صورت

  • Primary outcomes

    #1
    empty
    Speed of onset of treatment(The mean time to a 50% reduction in cal-culated total lesion scores) in every half of the face
    empty
    سرعت شروع درمان (زمان کاهش 50 درصد از تعداد کامل ضایعات اکنه ) در هر نیمه صورت
    empty
    at the end of the sixth and twelfth week
    empty
    پایان هفته ششم و دوازدهم مطالعه
    empty
    counting the comedones, papules and pustules
    empty
    شمارش کومدونها،پاپولها و پوستولها
    #2
    empty
    Recurrence
    empty
    عود ضایعات
    empty
    4 weeks after treatment
    empty
    4 هفته بعد از قطع درمان
    empty
    index of severity of acne=ASI Total lesion count = TL
    empty
    شمارش کلی ضایعات=TLCواندکس شدت آکنه=ASI

  • Secondary outcomes

    #1
    Quality of Life
    Skin erythema
    کیفیت زندگی
    اریتم پوست
    At the beginning of the study and the end of sixteenth week of the study
    before intervention and 16 weeks after the beginning of intervention
    در ابتدای مطالعه و انتهای هفته شانزدهم
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    Persian version of Cardiff Acne Disability Index questionnare
    Mexameter
    پرسشنامه فارسی شده Cardiff Acne Disability Index questionnare
    مکسامتر
    #2
    Skin erythema
    Skin hydration
    اریتم پوست
    هیدراسیون پوست
    before intervention and 16 weeks after the beginning of intervention
    At the beginning of the study and the end of sixteenth week of the study
    Mexameter
    Corneometer
    مکسامتر
    کورنئومتر
    #3
    Skin hydration
    Change in sebum production
    هیدراسیون پوست
    تغییر میزان سبوم
    Corneometer
    Sebumeter
    کورنئومتر
    سبومتر
    #4
    Change in sebum production
    Acne lesion and presence of Propionibacterium acnes bacteria
    تغییر میزان سبوم
    ضایعه آکنه و حضور باکتری پروپیونی باکتریوم آکنه
    Sebumeter
    Visiopor
    سبومتر
    ویزیوپور
    #5
    Acne lesion and presence of Propionibacterium acnes bacteria
    melanin
    ضایعه آکنه و حضور باکتری پروپیونی باکتریوم آکنه
    ملانین
    Visiopor
    mexameter
    ویزیوپور
    مکسامتر
    #6
    Skin marks
    patient satisfaction
    لکه های پوست
    رضایت بیمار
    At the beginning of the study and the end of sixteenth week of the study
    at the end of twelfth week
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    انتهای هفته دوازده
    visioface
    questionnaire
    ویزیوفیس
    پرسشنامه
    #7
    empty
    Evaluation of drug tolerance by the patient on each side of the face(burning, pruritus)
    empty
    ارزیابی تحمل دارو از نظر بیمار در دو نیمه صورت (سوزش ،خارش)
    empty
    at the end of the sixth, twelfth and sixteenth week of the study
    empty
    در پایان هفته های ششم، دوازدهم و شانزدهم مطالعه
    empty
    questionnaire
    empty
    پرسشنامه
    #8
    empty
    Evaluation of drug tolerance by the physician on each side of the face(erythema, dryness, peeling)
    empty
    ارزیابی تحمل دارو از نظز پزشک در دو نیمه صورت(اریتم ، خشکی ، پوسته ریزی)
    empty
    at the end of the sixth, twelfth and sixteenth week of the study
    empty
    در پایان هفته های ششم، دوازدهم و شانزدهم مطالعه
    empty
    examination
    empty
    معاینه

  • Sponsors / Funding sources

    #1
    40
    100

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: 2019-07-28, 1398/05/06
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
3
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 cal-culated total lesion scores) in every half of the face
Timepoint
at the end of the sixth and twelfth week
Method of measurement
counting the comedones, papules and pustules

4

Description
Recurrence
Timepoint
4 weeks after treatment
Method of measurement
index of severity of acne=ASI Total lesion count = TL

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
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