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Comparison of the efficacy, side effects, satisfaction and tolerability of platelet-rich plasma injection and microneedling platelet-rich plasma in the treatment of androgenetic alopecia

Protocol summary

Study aim
Comparison of the efficacy, side effects, satisfaction and tolerability of platelet-rich plasma injection and microneedling platelet-rich plasma in the treatment of androgenetic alopecia
Design
This phase 1 study is performed on 20 patients with hair loss. In each session, one group receives PRP as an injection and the other group receives PRP with microneedling. This method will be done once a month for 2 sessions. All patients before the treatment and 2 months after the second visit and photos are taken by digital camera and tricoscan. To determine the extent of improvement and compare the two groups, at the end of the study, photos of patients are examined by two neutral dermatologists. Patients' satisfaction and tolerance are also recorded and the results are compared.
Settings and conduct
This project is performed in the skin and stem cell research center of Tehran University of Medical Sciences and without informing the patients from the intervention groups, one group receives PRP by injection and the other group receives PRP with microneedling.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Platelet disorders, thrombocytopenia, patients receiving anticoagulants, patients with malignancy, receiving chemotherapy in the last 5 years, patients with sepsis, smoking, pregnancy, ulcers or active infections at the treatment site, not receiving any topical or systemic drugs In the last 3 months, women with hyperprolactinemia, women with hormonal disorders or polycystic ovaries. Exclusion criteria: Dissatisfaction with continuing treatment for any reason, lack of follow-up, severe allergic reaction to the injection.
Intervention groups
In each session, one group receives PRP as an injection and the other group receives PRP with microneedling.
Main outcome variables
The amount of hair loss; side effects; patient's satisfaction; tolerability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200127046282N6
Registration date: 2022-03-26, 1401/01/06
Registration timing: prospective

Last update: 2022-03-26, 1401/01/06
Update count: 0
Registration date
2022-03-26, 1401/01/06
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-14, 1401/01/25
Expected recruitment end date
2022-08-16, 1401/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy, side effects, satisfaction and tolerability of platelet-rich plasma injection and microneedling platelet-rich plasma in the treatment of androgenetic alopecia
Public title
Evaluation of the effectiveness of platelet-rich plasma and microneedling platelet-rich plasma on the treatment of hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Platelet disorders, thrombocytopenia, patients receiving anticoagulants, patients with malignancy, receiving chemotherapy in the last 5 years, patients with sepsis, smoking, pregnancy, ulcers or active infections at the treatment site, not receiving any topical or systemic drugs In the last 3 months, women with hyperprolactinemia, women with hormonal disorders or polycystic ovaries
Exclusion criteria:
Dissatisfaction with continuing treatment for any reason, lack of follow-up, severe allergic reaction to the injection
Age
From 18 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In each session, one group receives PRP as an injection and the other group receives PRP with microneedling.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-04-07, 1400/01/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.031

Health conditions studied

1

Description of health condition studied
Hair loss
ICD-10 code
L65.9
ICD-10 code description
Nonscarring hair loss, unspecified

Primary outcomes

1

Description
The amount of hair loss
Timepoint
Before treatment and two month after the last session
Method of measurement
Trichoscan

Secondary outcomes

1

Description
side effects
Timepoint
One week after session
Method of measurement
Questionnaire and visit

2

Description
satisfaction
Timepoint
Two months after the last session
Method of measurement
Questionnaire and visit

3

Description
Tolerability
Timepoint
Each session after transplantation
Method of measurement
Questionnaire and visit

Intervention groups

1

Description
Intervention group: In one group, PRP will be given as an injection in two sessions one month apart.
Category
Treatment - Other

2

Description
Intervention group: In one group, they will receive PRP with microneedling in two sessions one month apart.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Nilforoosh@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
Nilforoosh@sina.tums.ac.ir6657438
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and Stem Cell Research Center, Tehran 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
Skin and stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
‪Masoumeh Roohaninasab
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
masoomehrohani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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