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Investigating the safety and effectiveness of a solution containing plant exosomes compared to Wharton jelly stem cell exosomes and 5% minoxidil in the treatment of hair loss

Protocol summary

Study aim
Investigating the safety and effectiveness of a solution containing plant exosomes compared to Wharton jelly stem cell exosomes and 5% minoxidil in the treatment of hair loss
Design
This study is conducted in phase 1 and 2 on 30 patients suffering from hair loss. All patients are photographed by a digital camera and trichoscan before treatment and at each visit session. To determine the recovery rate and compare the two sides of the head, at the end of the study, the photos of the patients are examined by 2 impartial dermatologists. Also, the satisfaction of the patients is recorded and the results are compared.
Settings and conduct
This project is carried out at the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, and injections are used in hair loss areas without the knowledge of the patient and the doctor of the intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with female androgenic hair loss grade 5, patients aged 30 to 45 years, Hormonally healthy patients. Exclusion criteria: evidence of sepsis, immunosuppression and cancer, use of oral drug treatment, use of local drug treatment, discovery of another cause for the patient's hair loss, patient's non-cooperation.
Intervention groups
Intervention group: For the patient, once a day for three months, local use of herbal exosome is prescribed in the area with hair loss. Intervention group 2: For the patient, once a day for three months, local use of human exosome is prescribed in the area with hair loss. Control group: The patient is prescribed topical minoxidil 5% once a day for three months in the area with hair loss.
Main outcome variables
The amount of hair loss; side effects; effectiveness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200127046282N53
Registration date: 2024-08-17, 1403/05/27
Registration timing: prospective

Last update: 2024-08-17, 1403/05/27
Update count: 0
Registration date
2024-08-17, 1403/05/27
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
2024-08-21, 1403/05/31
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the safety and effectiveness of a solution containing plant exosomes compared to Wharton jelly stem cell exosomes and 5% minoxidil in the treatment of hair loss
Public title
Investigating the solution containing herbal exosomes in comparison with Wharton jelly stem cell exosomes and 5% minoxidil in the treatment of hair loss.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 45 years Hormonally healthy patients
Exclusion criteria:
Presence of evidence of sepsis, immunosuppression and cancer Use of oral drug treatment for androgenic hair loss (such as finasteride, dutasteride or any other anti-androgen drug) in 12 months the past Use of local drug treatment of androgenic hair loss (such as minoxidil, prostaglandin analogues, retinoids orCorticosteroids) in the last 12 months Discovering another cause for the patient's hair loss Non-cooperation of the patient until the end of the study
Age
From 18 years old to 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into three groups. The first group is treated with topical herbal exosome, the second group is treated with topical human exosome, and the third group is treated with topical minoxidil once a day for three months. Randomization is based on the table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome evaluator and the patients do not know about the specialty of the intervention groups. The injection syringe will be covered with aluminum foil. So it will be double blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Working Group/Ethics Committee in Research Faculty of Medicine - Tehran University of Medical Scienc
Street address
Elkhebal St., Quds St., Porsina St., Faculty of Medicine
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2024-08-12, 1403/05/22
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1403.205

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 starting treatment, end of the first, second, third month and one month after the end of the treatment period (end of the fourth month)
Method of measurement
Trichoscan

Secondary outcomes

1

Description
Side effects
Timepoint
Before starting treatment, end of the first, second, third month and one month after the end of the treatment period (end of the fourth month)
Method of measurement
Questionnaire and visit

2

Description
Effectiveness
Timepoint
Before starting treatment, end of the first, second, third month and one month after the end of the treatment period (end of the fourth month)
Method of measurement
Questionnaire and visit

Intervention groups

1

Description
Intervention group: For the patient, once a day for three months, local use of herbal exosome is prescribed in the area with hair loss.
Category
Treatment - Other

2

Description
Intervention group: For the patient, once a day for three months, local use of human exosome is prescribed in the area with hair loss.
Category
Treatment - Other

3

Description
Control group: The patient is prescribed topical minoxidil 5% once a day for three months in the area with hair loss.
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
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Central University Organization, sixth floor, Vice Chancellor for Research and Technology, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 of 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
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 of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
nilforoosh@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Skin and Stem cell Research Center of 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
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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