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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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  • Primary outcomes

    #1
    Skin erythema
    empty
    اریتم پوست
    empty
    before intervention and 16 weeks after the beginning of intervention
    empty
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    empty
    Mexameter
    empty
    مکسامتر
    empty
    #2
    Skin hydration
    empty
    هیدراسیون پوست
    empty
    before intervention and 16 weeks after the beginning of intervention
    empty
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    empty
    Corneometer
    empty
    کورنئومتر
    empty
    #3
    Change in sebum production
    empty
    تغییر میزان سبوم
    empty
    before intervention and 16 weeks after the beginning of intervention
    empty
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    empty
    Sebumeter
    empty
    سبومتر
    empty
    #4
    Acne lesion and presence of Propionibacterium acnes bacteria
    empty
    ضایعه آکنه و حضور باکتری پروپیونی باکتریوم آکنه
    empty
    before intervention and 16 weeks after the beginning of intervention
    empty
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    empty
    Visiopor
    empty
    ویزیوپور
    empty
    #5
    Skin marks
    empty
    لکه های پوست
    empty
    before intervention and 16 weeks after the beginning of intervention
    empty
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    empty
    visioface
    empty
    ویزیوفیس
    empty

  • Secondary outcomes

    #1
    empty
    Skin erythema
    empty
    اریتم پوست
    empty
    before intervention and 16 weeks after the beginning of intervention
    empty
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    empty
    Mexameter
    empty
    مکسامتر
    #2
    empty
    Skin hydration
    empty
    هیدراسیون پوست
    empty
    At the beginning of the study and the end of sixteenth week of the study
    empty
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    empty
    Corneometer
    empty
    کورنئومتر
    #3
    empty
    Change in sebum production
    empty
    تغییر میزان سبوم
    empty
    At the beginning of the study and the end of sixteenth week of the study
    empty
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    empty
    Sebumeter
    empty
    سبومتر
    #4
    empty
    Acne lesion and presence of Propionibacterium acnes bacteria
    empty
    ضایعه آکنه و حضور باکتری پروپیونی باکتریوم آکنه
    empty
    At the beginning of the study and the end of sixteenth week of the study
    empty
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    empty
    Visiopor
    empty
    ویزیوپور
    #5
    empty
    Skin marks
    empty
    لکه های پوست
    empty
    At the beginning of the study and the end of sixteenth week of the study
    empty
    قبل از شروع مداخله و 16 هفته بعد از مداخله
    empty
    visioface
    empty
    ویزیوفیس

  • Sharing plan

    empty
    No more information
    empty
    اطلاعات بیشتری وجود ندارد

Protocol summary

Study aim
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.
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 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.
Participants/Inclusion and exclusion criteria
being 12–45 years old, having 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 severity of skin lesions 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: 2018-02-14, 1396/11/25
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
empty
Actual recruitment end date
empty
Trial completion date
empty
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
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

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
Quality of Life
Timepoint
At the beginning of the study and the end of sixteenth week of the study
Method of measurement
Persian version of Cardiff Acne Disability Index questionnare

3

Description
Skin erythema
Timepoint
before intervention and 16 weeks after the beginning of intervention
Method of measurement
Mexameter

4

Description
Skin hydration
Timepoint
At the beginning of the study and the end of sixteenth week of the study
Method of measurement
Corneometer

5

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

6

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

7

Description
Skin marks
Timepoint
At the beginning of the study and the end of sixteenth week of the study
Method of measurement
visioface

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
40
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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