Protocol summary
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Study aim
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Determine the effect of wet cupping on moderate and severe acne
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Design
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A randomized, blinded, controlled clinical trial with a parallel group design of 108 patients, enrolled from 6 August 2018 , and followed for 3 months.
Randomization is done via "Blocked Randomization List".
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Settings and conduct
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The study is performed in the dermatology clinic of Shahid Faghihi Hospital. In this study, patients with mild to moderate acne between the ages of 18-35 years are randomly divided into intervention and control groups through the "Blocked Randomization List". All participants receive classical medicine, but in the intervention group, in addition to classical treatment, cupping is performed. The dermatologist and the person analyzing the information are unaware of the cupping.
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Participants/Inclusion and exclusion criteria
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Criteria for entering the plan: Includes severe and moderate acne on the face, and informed consent to participate in the study and non- pregnancy and no specific disease including hormonal imbalance, chronic diseases, anemia, other coagulation problems and other infectious diseases.
Exit criteria: Includes pregnancy and the emergence of specific illness during treatment, as well as cupping in the past three months and taking roaccutane over the past year.
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Intervention groups
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In this survey, the studied population is between the ages of 18-35 with moderate or severe acne. Participants are randomly divided into two groups. All participants (intervention group and control group) receive oral antibiotics based on the standard treatment protocol. In the intervention group, wet cupping is done twice, with 6 weeks interval (once at the beginning and second time 6 weeks later).
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Main outcome variables
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Severity of Acne
General information
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Reason for update
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At the discretion of the research group, instead of randomization through coins, the Internet randomization "Blocked Randomization List" was used, and unfortunately, the registration of this change in "IRCT" has been forgotten.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180623040199N1
Registration date:
2018-08-05, 1397/05/14
Registration timing:
prospective
Last update:
2020-07-21, 1399/04/31
Update count:
2
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Registration date
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2018-08-05, 1397/05/14
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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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2018-08-06, 1397/05/15
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Expected recruitment end date
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2019-01-05, 1397/10/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effectiveness of wet cupping on moderate and severe acne in patients under treatment with Azithromycin
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Public title
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Effectiveness of wet cupping on moderate and severe acne in patients under treatment with Azithromycin
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Moderate and severe acne on the face;
Informed consent to participate in the study;
No pregnancy;
Without any specific disease including chronic diseases, hormonal imbalance, anemia, and other coagulation problems, and Aids and other infectious diseases.
Exclusion criteria:
Pregnancy;
Occurrence of specific diseases during treatment;
Wet cupping in the past three months;
Taking roaccutane in the past year.
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Age
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From 18 years old to 35 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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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
108
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At first, according to the inclusion criteria, patients are selected and then according to the random sequence obtained through the "Blocked Randomization List" (random blocking with 6 blocks), in the same random order, patients will be divided into intervention and control groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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A dermatologist who checks patients at intervals is unaware of the wet cupping.
The analyzer is unaware of the patients whom wet cupping is done for them.
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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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2018-06-24, 1397/04/03
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Ethics committee reference number
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IR.KMU.REC.1397.096
Health conditions studied
1
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Description of health condition studied
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Acne
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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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Xii Diseases of skin and subcutaneous tissues
Primary outcomes
1
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Description
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Acne
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Timepoint
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Initially, the sixth week and the twelfth week
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Method of measurement
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By using Modified Global Acne Grading Score
Secondary outcomes
1
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Description
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Quality of Life
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Timepoint
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Initially and the twelfth week
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Method of measurement
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Questionnaire
2
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Description
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The prevalent temperament of people with acne
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Timepoint
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Initially and the twelfth week
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: In the back area between the first to third thoracic vertebra, during the first visit and the sixth week, the cupping will be done. In addition, antibiotic antibiotic azithromycin will be given 3 times a week.
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Category
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Treatment - Other
2
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Description
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Control group:They will receive antibiotic azithromycin three times a week, as well as sham cupping.
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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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124701
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Grant code / Reference number
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1603003000
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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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Kerman 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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It is published through the supplementary file
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When the data will become available and for how long
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6 months
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To whom data/document is available
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Researchers and other people can access data if they need it
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Under which criteria data/document could be used
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For using in systematic review articles, reprogramming and modeling can be used in other studies. In case of need, should be emailed to the programmer or entered university site.
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From where data/document is obtainable
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Executor of plan or University
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What processes are involved for a request to access data/document
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Email the scheduler,she answers.
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Comments
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All information is available to others for the advancement of science.