Comparison of The Efficacy of Platelet-Rich Plasma (PRP) Combined with Carboxytherapy vs PRP Monotherapy in Females with Androgenetic Alopecia Treated with Antiandrogen Drugs
Comparison of the Efficacy of Platelet-Rich Plasma (PRP) Combined with Carboxytherapy vs PRP Monotherapy in Females with Androgenetic Alopecia Treated with Antiandrogen Drugs
Design
A Clinical Trial, phase 2, was Conducted on 20 Patients with Androgenic Hair Loss in two groups Receiving PRP and Treated with PRP Combined with Carboxytherapy based on a random Number Table.
Settings and conduct
PRP Once A Month for Three Consecutive Months and Carboxytherapy Every Two Weeks for Six Weeks
Afzalipour Hospital
Kerman
Participants/Inclusion and exclusion criteria
Entry Criteria: Women without Previous Underlying Disease, Suffering from Androgenic Hair Loss
Exit Criteria: Patients Platelet Disorders, Thrombocytopenia, Anemia, Cardio-Pulmonary Diseases, Kidney Disease, Vasovagal Syncope, Uncontrolled Blood Pressure, Use of Anticoagulant Drugs, Thyroid Dysfunction, Diabetes, Sepsis and Cancer
Intervention groups
1- Platelet-Rich Plasma (PRP) Recipient Group
2- Treated with PRP combined with Carboxytherapy
Main outcome variables
Hair Loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220919055994N2
Registration date:2023-05-30, 1402/03/09
Registration timing:prospective
Last update:2023-05-30, 1402/03/09
Update count:0
Registration date
2023-05-30, 1402/03/09
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
2023-06-21, 1402/03/31
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
Comparison of The Efficacy of Platelet-Rich Plasma (PRP) Combined with Carboxytherapy vs PRP Monotherapy in Females with Androgenetic Alopecia Treated with Antiandrogen Drugs
Public title
The effectiveness of Combined Treatment of Carboxytherapy and Platelet-Rich Plasma (PRP) Compared to Platelet-Rich Plasma Alone, in the Treatment of Women with Androgenic Hair Loss Treated with Anti-Androgen Drugs.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Androgenetic Alopecia
Exclusion criteria:
Platelet Disorders, Thrombocytopenia, Anemia, Cardio-Pulmonary Diseases, Kidney Disease, Vasovagal Syncope, Uncontrolled Blood Pressure, Use of Anticoagulant Drugs, Thyroid Dysfunction, Diabetes, Sepsis and Cancer.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Afzalipour Hospital, Next to Shahid Bahonar University, Imam Khomeini Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2023-05-22, 1402/03/01
Ethics committee reference number
IR.KMU.AH.REC.1402.033
Health conditions studied
1
Description of health condition studied
Women without Previous Underlying Disease, Suffering from Androgenic Hair Loss
ICD-10 code
L66
ICD-10 code description
Cicatricial alopecia [scarring hair loss]
Primary outcomes
1
Description
Androgenic Hair Loss
Timepoint
Once a Month
Method of measurement
Physical Examination
Secondary outcomes
empty
Intervention groups
1
Description
All Patients are Randomly Divided (based on the table of Random Numbers) into two Groups Receiving PRP and Treated with PRP Combined with Carboxytherapy. For All Patients, the Use of Cyproterone Compound and Spironolactone (100 Mg) Once a Day Is Recommended. PRP Is Performed Once a Month for Three Consecutive Months and Carboxytherapy is Performed Every two Weeks for Six Weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afazalipour Hospital
Full name of responsible person
Fatemeh Rastaghi
Street address
Afzalipour Hospital, Next to Shahid Bahonar University, Imam Khomeini Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
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
Afzalipour Hospital, Next to Shahid Bahonar University, Imam Khomeini Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 76 1691 3355
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
Afzalipour Hospital, Next to Shahid Bahonar University, Imam Khomeini Highway, Kerman, Iran
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
Afzalipour Hospital, Next to Shahid Bahonar University, Imam Khomeini Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8328
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
Dermatologist
Street address
Afzalipour Hospital, Next to Shahid Bahonar University, Imam Khomeini Highway, 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)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the Results will be Published as a Group and the Names of the Patients will not be Mentioned at any Stage.
When the data will become available and for how long
6 Month
To whom data/document is available
Dermatologists
Under which criteria data/document could be used
Dermatologists,
Raw Data Are Not Published, Final Results Are Reported.
From where data/document is obtainable
Via the Responsible Author's Email: fatemeh_rastaghi@yahoo.com, phone: 03431328000
Mobile: 00989391364922
What processes are involved for a request to access data/document
After A Week and the Author's Approval, the Information Will be Emailed to the Recipient.