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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Protocol summary
Comparison of the efficacy and safety of mesotherapy and mesonidelling With HAIRCARE drug REVITACARE brand in the treatment of male and female pattern androgenic alopecia: A double-blind controlled randomized clinical trial
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
Comparison of the efficacy and safety of mesotherapy and mesonidelling With medical device class 3 (HAIRCARE drug) REVITACARE brand in the treatment of male and female pattern androgenic alopecia: A double-blind controlled randomized clinical trial
مقایسه اثربخشی و ایمنی مزوتراپی و مزونیدلینگ با داروی HAIRCARE برند REVITACARE در درمان آلوپسی آندروژنیک مردانه و زنانه:یک کارآزمایی بالینی تصادفی شده دوسوکور
مقایسه اثربخشی و ایمنی مزوتراپی و مزونیدلینگ با مدیکال دیوایس کلاس سه HAIRCARE برند REVITACARE در درمان آلوپسی آندروژنیک مردانه و زنانه:یک کارآزمایی بالینی تصادفی شده دوسوکور
مقایسه اثربخشی و ایمنی مزوتراپی و مزونیدلینگ با دارویمدیکال دیوایس کلاس سه HAIRCARE برند REVITACARE در درمان آلوپسی آندروژنیک مردانه و زنانه:یک کارآزمایی بالینی تصادفی شده دوسوکور
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 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 blinded
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
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 blindedblind،e
این مطالعه در بیمارستان رسول اکرم انجام می پذیرد. ۳۰ بیمار به شکل رندوم در دو گروه A و B قرار می گیرند. گروه اول تحت درمان با مزوتراپی و گروه دوم تحت درمان با مزونیدلینگ، هر دو گروه به مدت ۶ جلسه با فواصل ۳ هفته با داروی HAIRCARE برند REVITACARE قرار می گیرند. بیماران، پس از اتمام درمان تحت بررسی با روش های زیر قرار خواهند گرفت.
۱. تعیین شدت آلوپسی بر اساس معیار لودویگ در female pattern یا معیار همیلتون در male pattern
۲. تصویر برداری و Patient global assessment score
پزشک و متخصص امار کور خواهند شد.
این مطالعه در بیمارستان رسول اکرم انجام می پذیرد. ۳۰ بیمار به شکل رندوم در دو گروه A و B قرار می گیرند. گروه اول تحت درمان با مزوتراپی و گروه دوم تحت درمان با مزونیدلینگ، هر دو گروه به مدت ۶ جلسه با فواصل ۳ هفته با مدیکال دیوایس کلاس سه( HAIRCARE ) برند REVITACARE قرار می گیرند. بیماران، پس از اتمام درمان تحت بررسی با روش های زیر قرار خواهند گرفت.
۱. تعیین شدت آلوپسی بر اساس معیار لودویگ در female pattern یا معیار همیلتون در male pattern
۲. تصویر برداری و Patient global assessment score
پزشک و متخصص امار کور خواهند شد.
این مطالعه در بیمارستان رسول اکرم انجام می پذیرد. ۳۰ بیمار به شکل رندوم در دو گروه A و B قرار می گیرند. گروه اول تحت درمان با مزوتراپی و گروه دوم تحت درمان با مزونیدلینگ، هر دو گروه به مدت ۶ جلسه با فواصل ۳ هفته با دارویمدیکال دیوایس کلاس سه( HAIRCARE ) برند REVITACARE قرار می گیرند. بیماران، پس از اتمام درمان تحت بررسی با روش های زیر قرار خواهند گرفت. ۱. تعیین شدت آلوپسی بر اساس معیار لودویگ در female pattern یا معیار همیلتون در male pattern ۲. تصویر برداری و Patient global assessment score پزشک و متخصص امار کور خواهند شد.
بیماران به طور تصادفی به ۲ گروه ۱۵ نفره تقسیم می شوند. گروه اول تحت درمان با مزوتراپی و گروه دوم تحت درمان با مزونیدلینگ، هر دو گروه به مدت ۶ جلسه با فواصل ۳ هفته، با داروی HAIRCARE برند REVITACARE قرار می گیرند.
بیماران به طور تصادفی به ۲ گروه ۱۵ نفره تقسیم می شوند. گروه اول تحت درمان با مزوتراپی و گروه دوم تحت درمان با مزونیدلینگ، هر دو گروه به مدت ۶ جلسه با فواصل ۳ هفته، با HAIRCARE برند REVITACARE قرار می گیرند.
بیماران به طور تصادفی به ۲ گروه ۱۵ نفره تقسیم می شوند. گروه اول تحت درمان با مزوتراپی و گروه دوم تحت درمان با مزونیدلینگ، هر دو گروه به مدت ۶ جلسه با فواصل ۳ هفته، با داروی HAIRCARE برند REVITACARE قرار می گیرند.
General information
empty
word correction from "drug" to " medical device class 3"
word correction from "drug" to " medical device class 3"
empty
تصحیح واژه " دارو" به "مدیکال دیوایس کلاس سه"
تصحیح واژه " دارو" به "مدیکال دیوایس کلاس سه"
Effectiveness of of HAIRCARE in treatments androgenetic alopecia
Effectiveness of medical device class 3 HAIRCARE in treatments androgenetic alopecia
Effectiveness of ofmedical device class 3 HAIRCARE in treatments androgenetic alopecia
موثر بودن داروی HAIRCARE در درمان آلوپسی
موثر بودن مدیکال دیوایس کلاس سه HAIRCARE در درمان آلوپسی
موثر بودن دارویمدیکال دیوایس کلاس سه HAIRCARE در درمان آلوپسی
Comparison of the efficacy and safety of mesotherapy and mesonidelling With HAIRCARE drug REVITACARE brand in the treatment of male and female pattern androgenic alopecia: A double blinded controlled randomized clinical trial
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
Comparison of the efficacy and safety of mesotherapy and mesonidellingmeso-needling With HAIRCARE drugmedical device class 3 REVITACARE brand in the treatment of male and female pattern androgenic alopecia: A double blinded controlled randomized clinical trial
مقایسه اثربخشی و ایمنی مزوتراپی و مزونیدلینگ با داروی HAIRCARE برند REVITACARE در درمان آلوپسی آندروژنیک مردانه و زنانه: یک کارآزمایی بالینی تصادفی شده دوسوکور
مقایسه اثربخشی و ایمنی مزوتراپی و مزونیدلینگ با مدیکال دیوایس کلاس سه HAIRCARE برند REVITACARE در درمان آلوپسی آندروژنیک مردانه و زنانه: یک کارآزمایی بالینی تصادفی شده دوسوکور
مقایسه اثربخشی و ایمنی مزوتراپی و مزونیدلینگ با دارویمدیکال دیوایس کلاس سه HAIRCARE برند REVITACARE در درمان آلوپسی آندروژنیک مردانه و زنانه: یک کارآزمایی بالینی تصادفی شده دوسوکور
Intervention groups
#1
Control group: The control group is treated with Haircare drug 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.
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.
Control group: The control group is treated with Haircare drug( 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.
گروه کنترل: گروه کنترل، با داروی Haircare به میزان 2.5 سی سی به صورت مزوتراپی تحت درمان قرار می گیرد. برای انجام مزوتراپی، ابتدا از کرم بی حسی موضعی XylaP به مدت نیم ساعت استفاده شده، سپس با گاز استریل بی حسی برداشته شده و محل درمان با پنبه الکل ضدعفونی می شود. مزوتراپی، به شکل تزریق اینترادرمال مستقیم در نواحی دچار ریزش مو، به فاصله یک سانتی متر و با استفاده از سرنگ انسولین گیج ۲۷، در هر بار تزریق به میزان ۰/۱ cc، انجام می شود.
گروه کنترل: گروه کنترل، با مدیکال دیوایس کلاس سه( Haircare )به میزان 2.5 سی سی به صورت مزوتراپی تحت درمان قرار می گیرد. برای انجام مزوتراپی، ابتدا از کرم بی حسی موضعی XylaP به مدت نیم ساعت استفاده شده، سپس با گاز استریل بی حسی برداشته شده و محل درمان با پنبه الکل ضدعفونی می شود. مزوتراپی، به شکل تزریق اینترادرمال مستقیم در نواحی دچار ریزش مو، به فاصله یک سانتی متر و با استفاده از سرنگ انسولین گیج ۲۷، در هر بار تزریق به میزان ۰/۱ cc، انجام می شود.
گروه کنترل: گروه کنترل، با دارویمدیکال دیوایس کلاس سه( Haircare )به میزان 2.5 سی سی به صورت مزوتراپی تحت درمان قرار می گیرد. برای انجام مزوتراپی، ابتدا از کرم بی حسی موضعی XylaP به مدت نیم ساعت استفاده شده، سپس با گاز استریل بی حسی برداشته شده و محل درمان با پنبه الکل ضدعفونی می شود. مزوتراپی، به شکل تزریق اینترادرمال مستقیم در نواحی دچار ریزش مو، به فاصله یک سانتی متر و با استفاده از سرنگ انسولین گیج ۲۷، در هر بار تزریق به میزان ۰/۱ cc، انجام می شود.
#2
Intervention group: In the intervention group, patients receive HAIRCARE medicine 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.
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.
Intervention group: In the intervention group, patients receive medical device class 3 (HAIRCARE medicine) 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.
گروه مداخله: در گروه مداخله بیماران داروی HAIRCARE را به صورت مزونیدلینگ دریافت می کنند. برای انجام میکرونیدلینگ، ابتدا از کرم بی حسی موضعی XylaP به مدت نیم ساعت استفاده شده، سپس با گاز استریل بی حسی برداشته شده و محل درمان با پنبه الکل ضدعفونی می شود و Endpoint درمانی خونریزی نقطه ای است.
گروه مداخله: در گروه مداخله بیماران مدیکال دیوایس کلاس سه HAIRCARE را به صورت مزونیدلینگ دریافت می کنند. برای انجام میکرونیدلینگ، ابتدا از کرم بی حسی موضعی XylaP به مدت نیم ساعت استفاده شده، سپس با گاز استریل بی حسی برداشته شده و محل درمان با پنبه الکل ضدعفونی می شود و Endpoint درمانی خونریزی نقطه ای است.
گروه مداخله: در گروه مداخله بیماران دارویمدیکال دیوایس کلاس سه HAIRCARE را به صورت مزونیدلینگ دریافت می کنند. برای انجام میکرونیدلینگ، ابتدا از کرم بی حسی موضعی XylaP به مدت نیم ساعت استفاده شده، سپس با گاز استریل بی حسی برداشته شده و محل درمان با پنبه الکل ضدعفونی می شود و Endpoint درمانی خونریزی نقطه ای است.
Recruitment centers
#1
Name of recruitment center - English: بیمارستان حضرت رسول اکرم (ص)
Name of recruitment center - Persian: Hazrat Rasool Akram Hospital
Full name of responsible person - English: Azadeh Goodarzi
Full name of responsible person - Persian: آزاده گودرزی
Street address - English: Sattar Khan Street, Maziar Mansouri Street, Rasool Akram Hospital
Street address - Persian: خیابان ستارخان، خیابان مازیار منصوری، بیمارستان رسول اکرم (ص)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 86701
Fax:
Email: goodarzi.a@iums.ac.ir
Web page address:
Name of recruitment center - English: Rasoul Akram Hospital
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
Full name of responsible person - English: Azadeh Goodarzi
Full name of responsible person - Persian: آزاده گودرزی
Street address - English: Hazrat-e Rasool General Hospital, Niyayesh St. Satarkhan St. Tehran, Iran.
Street address - Persian: تهران، خیابان ستارخان، خیابان نیایش، بیمارستان عمومی حضرت رسول (ص)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14456 13131
Phone: +98 21 6435 1000
Fax:
Email: goodarzi.a@iums.ac.ir
Web page address:
Name of recruitment center - English: بیمارستان حضرت رسول اکرم (ص)Rasoul Akram Hospital Name of recruitment center - Persian: Hazrat Rasool Akram Hospitalبیمارستان حضرت رسول اکرم Full name of responsible person - English: Azadeh Goodarzi Full name of responsible person - Persian: آزاده گودرزی Street address - English: Sattar Khan Street, Maziar Mansouri Street,Hazrat-e Rasool AkramGeneral Hospital, Niyayesh St. Satarkhan St. Tehran, Iran. Street address - Persian: تهران، خیابان ستارخان، خیابان مازیار منصورینیایش، بیمارستان عمومی حضرت رسول اکرم (ص) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵14456 13131 Phone: +98 21 867016435 1000 Fax: Email: goodarzi.a@iums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: دکتر سید عباس متولیان
Full name of responsible person - Persian: Dr. Seyed Abbas Matolian
Street address - English: Tehran Hemat Highway next to Milad Tower
Street address - Persian: بزرگراه تهران همت جنب برج میلاد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 86701
Fax:
Email: research-m@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hossein Keyvani
Full name of responsible person - Persian: دکترحسین کیوانی
Street address - English: Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 86701
Fax:
Email: research-m@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: دکتر سید عباس متولیانDr. Hossein Keyvani Full name of responsible person - Persian: Dr. Seyed Abbas Matolianدکترحسین کیوانی Street address - English: TehranIran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran Street address - Persian: تهران، بزرگراه تهران همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵1449614535 Phone: +98 21 86701 Fax: Email: research-m@iums.ac.ir Web page address:
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