Protocol summary
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Study aim
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Comparison of the efficacy and safety of mesotherapy and mesonidelling With medical device class 3 (HAIRCARE ) REVITACARE brand in the treatment of male and female pattern androgenic alopecia: A double-blind controlled randomized clinical trial
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Design
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A clinical trial with a control group, with a parallel group, double-blind, randomized phase 3 on 30 patients, which was used for randomization from the table of random numbers.
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Settings and conduct
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This study is conducted in Rasul Akram Hospital. 30 patients are randomly placed in two groups A and B. The first group is treated with mesotherapy and the second group is treated with mesonedling. Both groups are treated with medical device class 3 HAIRCARE brand REVITACARE for 6 sessions with 3-week intervals. Patients will be examined with the following methods after completing the treatment.
1. Determining the severity of alopecia based on Ludwig criteria in female pattern or Hamilton criteria in male pattern
2. Imaging and Patient global assessment score
The doctor and statistician will be blind،e
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Participants/Inclusion and exclusion criteria
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Entry criteria:
1- Women and men with hereditary hormonal hair loss
2- 18 years old and above and less than 50 years old,
3- Hamilton score 2 to 5 in men and Ludwig score 1 to 3 in women
4- Full satisfaction of the patient to participate in the plan.
Inclusion criteria:
1-Platelet disorders or thrombocytopenia
2-Patients receiving anticoagulant medication
3- Patients with malignancy
4- Receiving chemotherapy in the last 5 years
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Intervention groups
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Patients are randomly divided into 2 groups of 15 people. The first group is treated with mesotherapy and the second group is treated with mesonedling, both groups are treated with HAIRCARE brand REVITACARE for 6 sessions with 3 week intervals.
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Main outcome variables
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Determining the severity of alopecia, standard photography score, patient satisfaction score
General information
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Reason for update
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word correction from "drug" to " medical device class 3"
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230401057792N1
Registration date:
2023-04-17, 1402/01/28
Registration timing:
prospective
Last update:
2024-06-15, 1403/03/26
Update count:
1
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Registration date
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2023-04-17, 1402/01/28
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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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2023-05-15, 1402/02/25
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Expected recruitment end date
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2023-09-23, 1402/07/01
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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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Comparison of the efficacy and safety of mesotherapy and meso-needling With HAIRCARE medical device class 3 REVITACARE brand in the treatment of male and female pattern androgenic alopecia: A double blinded controlled randomized clinical trial
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Public title
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Effectiveness of medical device class 3 HAIRCARE in treatments androgenetic alopecia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Men and women with hereditary hormonal hair loss
Exclusion criteria:
Severe allergic reaction to the injection
Receiving any topical or systemic medication in the last 3 months for hair loss
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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3
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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:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, simple randomization method will be used. In this way, we will have 2 containers. In one of the containers, there will be 30 numbers from 1 to 30, and in vase number 2, there will be 30 sealed envelopes, in which the desired type of treatment is inserted. The process of randomization will be that first we will choose a number randomly from the first container and we will choose an envelope randomly from the second container and put them in a designed box. The number removed from container #1 will take the treatment that was removed from container #2. We will do this for all 30 numbers. That is, we will have 30 numbers in the desired box, and in front of each number there will be an envelope with treatment inside. In this method, the type of intervention that exists inside each envelope is unclear, which is the randomization concealment method. In fact, the treatment assigned to the numbers is not known until the person comes and the envelope is opened for him, and secondly, the names of the treatments will not be clear inside the envelopes, and the names of the treatments will be A and B, and only the study designer He will know about the type of treatment A and B
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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 doctor who rates the results of the study and the statistician do not know which treatment group the patient is in.
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Placebo
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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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2023-03-05, 1401/12/14
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Ethics committee reference number
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IR.IUMS.FMD.REC.1401.697
Health conditions studied
1
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Description of health condition studied
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Androgenic alopecia
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ICD-10 code
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L64
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ICD-10 code description
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Androgenic alopecia
Primary outcomes
1
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Description
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The thickness of the hair
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Timepoint
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The third and sixth sessions and one month after the end of the treatment
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Method of measurement
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by the hair analyzer
2
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Description
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Hair density
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Timepoint
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The third and sixth sessions and one month after the end of the treatment
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Method of measurement
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by the hair analyzer
Secondary outcomes
1
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Description
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Patient satisfaction score of treatment
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Timepoint
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After the third and sixth sessions and one month after the treatment
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Method of measurement
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Based on patient global assessment score
2
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Description
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Doctor's satisfaction
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Timepoint
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After the third and sixth sessions and one month after the treatment
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Method of measurement
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Based on Physician global assessment score
3
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Description
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Tolerability of treatment
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Timepoint
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during treatment
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Method of measurement
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questionnaire
Intervention groups
1
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Description
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Control group: The control group is treated with Haircare ( medical device class 3 ) in the amount of 2.5 cc in the form of mesotherapy. To perform mesotherapy, XylaP topical anesthetic cream is first used for half an hour, then the anesthesia is removed with sterile gauze and the treatment area is disinfected with alcohol cotton. Mesotherapy is performed in the form of direct intradermal injection in the areas with hair loss, at a distance of one centimeter, using a 27-gauge insulin syringe, at the rate of 0.1 cc per injection.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: In the intervention group, patients receive medical device class 3 (HAIRCARE ) in the form of mesonedling. To perform microneedling, XylaP topical anesthetic cream is first used for half an hour, then the anesthesia is removed with sterile gauze and the treatment area is disinfected with alcohol cotton, and the endpoint treatment is point bleeding.
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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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Not applicable