View older revisions Content changed at 2024-06-15, 1403/03/26

Protocol summary

Study aim
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
Design
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.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Determining the severity of alopecia, standard photography score, patient satisfaction score

General information

Reason for update
word correction from "drug" to " medical device class 3"
Acronym
IRCT registration information
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
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
Neda Safarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 1021
Email address
nmed29251@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effectiveness of medical device class 3 HAIRCARE in treatments androgenetic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Double blinded
Blinding description
The doctor who rates the results of the study and the statistician do not know which treatment group the patient is in.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine of University of Iran
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-03-05, 1401/12/14
Ethics committee reference number
IR.IUMS.FMD.REC.1401.697

Health conditions studied

1

Description of health condition studied
Androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia

Primary outcomes

1

Description
The thickness of the hair
Timepoint
The third and sixth sessions and one month after the end of the treatment
Method of measurement
by the hair analyzer

2

Description
Hair density
Timepoint
The third and sixth sessions and one month after the end of the treatment
Method of measurement
by the hair analyzer

Secondary outcomes

1

Description
Patient satisfaction score of treatment
Timepoint
After the third and sixth sessions and one month after the treatment
Method of measurement
Based on patient global assessment score

2

Description
Doctor's satisfaction
Timepoint
After the third and sixth sessions and one month after the treatment
Method of measurement
Based on Physician global assessment score

3

Description
Tolerability of treatment
Timepoint
during treatment
Method of measurement
questionnaire

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Azadeh Goodarzi
Street address
Hazrat-e Rasool General Hospital, Niyayesh St. Satarkhan St. Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14456 13131
Phone
+98 21 6435 1000
Email
goodarzi.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keyvani
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
research-m@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
Azadeh Goodarzi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
goodarzi.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Goodarzi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
goodarzi.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Neda Safarzade
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
nmed29251@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
Not applicable
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