Protocol summary
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Study aim
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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.
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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12–45 years old, facial acne vulgaris, mild to moderate
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Intervention groups
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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
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Main outcome variables
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number and acne severity index
side effects
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-01-02, 1396/10/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-12-06, 1396/09/15
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Expected recruitment end date
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2018-08-06, 1397/05/15
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Actual recruitment start date
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2017-12-06, 1396/09/15
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Actual recruitment end date
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2019-07-04, 1398/04/13
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Trial completion date
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2019-07-04, 1398/04/13
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Scientific title
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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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Public title
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Myrtus communis effect in acne treatment
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 12 years old to 45 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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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
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-08, 1396/07/16
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Ethics committee reference number
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IR.IUMS.FMD.REC 1396.9321309010
Health conditions studied
1
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Description of health condition studied
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Acne vulgaris
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ICD-10 code
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L70.0
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ICD-10 code description
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Acne vulgaris
Primary outcomes
1
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Description
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Total lesion Count
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Timepoint
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At the beginning of the study and at the end of the sixth, twelfth and sixteenth week of the study
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Method of measurement
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Counting the Comedones, Papules and Pustules
2
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Description
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Severity of Acne
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Timepoint
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At the beginning of the study and at the end of the sixth, twelfth and sixteenth week of the study
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Method of measurement
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Acne Severity Index
3
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Description
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Speed of onset of treatment(The mean time to a 50% reduction in acne lesion ) in every half of the face
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Timepoint
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At the end of the sixth and twelfth week
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Method of measurement
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Index of Severity of Acne=ASI Total lesion Count = TLC
4
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Description
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Recurrence
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Timepoint
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4 weeks after treatment
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Method of measurement
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Index of Severity of Acne=ASI Total lesion Count = TLC
Secondary outcomes
1
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Description
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Side effects
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Timepoint
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At the end of the sixth, twelfth and sixteenth week of the study
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Method of measurement
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Common terminology criteria for Adverse Evently v4.02009
2
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Description
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Skin erythema
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Timepoint
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Before intervention and 16 weeks after the beginning of intervention
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Method of measurement
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Mexameter
3
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Description
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Skin hydration
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Timepoint
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At the beginning of the study and the end of sixteenth week of the study
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Method of measurement
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Corneometer
4
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Description
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Change in sebum production
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Timepoint
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At the beginning of the study and the end of sixteenth week of the study
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Method of measurement
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Sebumeter
5
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Description
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Acne lesion and presence of Propionibacterium acnes bacteria
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Timepoint
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At the beginning of the study and the end of sixteenth week of the study
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Method of measurement
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Visiopor
6
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Description
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Melanin
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Timepoint
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At the beginning of the study and the end of sixteenth week of the study
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Method of measurement
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Mexameter
7
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Description
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Patient satisfaction
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Timepoint
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At the end of twelfth week
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Method of measurement
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questionnaire
8
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Description
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Evaluation of drug tolerance by the patient on each side of the face(burning, pruritus)
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Timepoint
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At the end of the sixth, twelfth and sixteenth week of the study
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Method of measurement
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questionnaire
9
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Description
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Evaluation of drug tolerance by the physician on each side of the face(erythema, dryness, peeling)
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Timepoint
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At the end of the sixth, twelfth and sixteenth week of the study
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Method of measurement
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examination
Intervention groups
1
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Description
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Intervention group: the Myrtus communis topical formulation will be applied on one side of the face two times a day for 12 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: the clindamycin1% will be applied on the other side of the face for 12 weeks
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available