Safety and effectiveness of fibroblast-derived exosome injection in combination with minoxidil in patients with androgenic hair loss compared to minoxidil alone: a randomized clinical trial
Safety and effectiveness of fibroblast-derived exosome injection in combination with minoxidil in patients with androgenic hair loss compared to minoxidil alone: a randomized clinical trial
Design
Phase 1-2 study, parallel, single-blind, Random assignment to intervention and control groups, with two intervention and control groups
Settings and conduct
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: no use of topical or oral medication for the treatment of alopecia during the last six months. Exclusion criteria: age under 18 years, pregnancy, breastfeeding, history of malignant diseases, use of any local or systemic treatment during the research.
Intervention groups
Intervention group: One side of the patient's head is treated with exosome injection (5 sessions at an interval of 3 weeks) and topical minoxidil 5% (15 weeks). Control group: One side of the patient's head is treated with topical minoxidil 5% (15 weeks).
Main outcome variables
Hair density, side effects, satisfaction, tolerability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N54
Registration date:2024-08-19, 1403/05/29
Registration timing:prospective
Last update:2024-08-19, 1403/05/29
Update count:0
Registration date
2024-08-19, 1403/05/29
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
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and effectiveness of fibroblast-derived exosome injection in combination with minoxidil in patients with androgenic hair loss compared to minoxidil alone: a randomized clinical trial
Public title
Investigation of exosome injection in combination with minoxidil in patients with androgenic hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and above and less than 45 years
Hamilton score 2 to 5 in male and female hair loss
Complete consent of the patient to participate in the plan
Exclusion criteria:
Patients with malignancy
Receiving chemotherapy in the last 5 years
Patients with sepsis
smoking
Pregnancy or breastfeeding
Active wound or infection at the treatment site
Receiving any topical or systemic medication in the last 3 months for hair loss
Age
From 18 years old to 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with computer generated random numbers table and sequentially numbered containers each representing a block consisting of ten patients are used for the treatment assignments.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome evaluator will not know about the study groups (left and right).
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
Faculty of Medicine, Porsina St., Quds St., Elkhebal St.
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2024-08-12, 1403/05/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.206
Health conditions studied
1
Description of health condition studied
Androgenetic alopecia
ICD-10 code
L64.9
ICD-10 code description
Androgenic alopecia, unspecified
Primary outcomes
1
Description
Hair density
Timepoint
before the start of treatment and three and six months after the start of the intervention
Method of measurement
Biometric examination will be done and the findings from VISIOFACE and TES-TB (hair loss type with X1 lens, hair density and scalp condition with X60Triple lens, hair diameter and PORE condition with KPL X150 lens and hair shaft surface condition with X700 lens) It will be recorded for each patient.
Secondary outcomes
1
Description
Side effects
Timepoint
During treatment
Method of measurement
Questionnaire and observation
2
Description
Satisfaction
Timepoint
A month after the last session
Method of measurement
Satisfaction Questionnaire and visit
3
Description
Tolerability
Timepoint
During treatment
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Intervention group: One side of the patient's head is treated with exosome injection (5 sessions at an interval of 3 weeks) and topical minoxidil 5% (15 weeks).
Category
Treatment - Other
2
Description
Control group: One side of the patient's head is treated with topical minoxidil 5% (15 weeks).
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