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Comparing the Effectiveness of Combined Treatment of Carboxy Therapy, Platelet-Rich Plasma (PRP) and Topical Finasteride with Platelet-Rich Plasma Plus Topical Finasteride, in the Treatment of Male Pattern Androgenic Hair Loss

Protocol summary

Study aim
Comparison of the Effectiveness of Combined Treatment of Carboxytherapy, Platelet-Rich Plasma (PRP) and Topical Finasteride with Platelet-Rich Plasma Plus Topical Finasteride, in the Treatment of Male Pattern Androgenic Hair Loss
Design
In Each Treatment Session, and then three Months after the end of the Treatment, the Ratio of Terminal Hair to Vulus, Hair Density Per Square Centimeter and Hair Diameter Were Measured by The Photofinder Device, and Macroscopic Photos were also taken of the Patient with a Camera and Compared. Be. Statistical Analysis is done by SPSS Version 22.
Settings and conduct
Afzalipour Hospital
Participants/Inclusion and exclusion criteria
It is Men Who Have Suffered Androgenic Hair Loss (Severity 2-4 according to the Hamilton-Norwood Criteria) without any Underlying Disease
Intervention groups
It is Men Who Have Suffered Androgenic Hair Loss (Severity 2-4 according to the Hamilton-Norwood Criteria) without any Underlying Disease.
Main outcome variables
Hair Loss Treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220919055994N1
Registration date: 2023-05-26, 1402/03/05
Registration timing: prospective

Last update: 2023-05-26, 1402/03/05
Update count: 0
Registration date
2023-05-26, 1402/03/05
Registrant information
Name
fatemeh rastaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3872 0811
Email address
fatemeh_rastaghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2023-08-20, 1402/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Combined Treatment of Carboxy Therapy, Platelet-Rich Plasma (PRP) and Topical Finasteride with Platelet-Rich Plasma Plus Topical Finasteride, in the Treatment of Male Pattern Androgenic Hair Loss
Public title
Effectiveness of Combined Treatment of Carboxytherapy, Platelet-Rich Plasma (PRP) and Local Finasteride with Platelet-Rich Plasma in the Treatment of Androgenic Hair Loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
It is Men Who Have Suffered Androgenic Hair Loss (Severity 2-4 according to the Hamilton-Norwood Criteria) without any Underlying Disease
Exclusion criteria:
Patients include Platelet Disorders, Thrombocytopenia, Anemia, Cardio-Pulmonary Diseases, Kidney Disease, Vasovagal Syncope, Uncontrolled Blood Pressure, Taking Anticoagulant Drugs, Thyroid Dysfunction, Diabetes, Sepsis.
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
All Patients are Randomly Divided (based on the table of random numbers) into two Groups Receiving PRP or PRP with Carboxy Therapy.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2023-04-09, 1402/01/20
Ethics committee reference number
IR.KMU.AH.REC.1402.006

Health conditions studied

1

Description of health condition studied
Androgenic hair loss
ICD-10 code
L66
ICD-10 code description
Cicatricial alopecia [scarring hair loss]

Primary outcomes

1

Description
Male Hair Loss
Timepoint
3 Months
Method of measurement
PhotoFinder Device

Secondary outcomes

empty

Intervention groups

1

Description
The First Group Receiving PRP
Category
Treatment - Drugs

2

Description
Intervention group: The second group receiving PRP along with Carboxytherapy
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Fatemeh Rastaghi
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 939 136 4922
Fax
Email
fatemeh_rastaghi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Rastaghi
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
fatemeh_rastaghi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Rastaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
fatemeh_rastaghi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Rastaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
fatemeh_rastaghi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Rastaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
fatemeh_rastaghi@yahoo.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
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information is Shared, but the Method of Dissemination is not Clear
When the data will become available and for how long
Information is Shared, but the Method of Dissemination is not Clear
To whom data/document is available
Dermatologists
Under which criteria data/document could be used
Information is shared, but the method of dissemination is not clear
From where data/document is obtainable
Corresponding Author Email address and phone number
What processes are involved for a request to access data/document
Information is Shared, but the Method of Dissemination is not Clear
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