Evaluating the safety and efficacy of fractional CO2 laser in combination with topical minoxidil 15% compared to topical minoxidil 15% alone in the treatment of patients with androgenetic hair loss: a single-blind clinical trial study
En Evaluating the safety and efficacy of fractional CO2 laser in combination with topical minoxidil 15% compared to topical minoxidil 15% alone in the treatment of patients with androgenetic hair loss: a single-blind clinical trial study
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: Not using topical or oral medication for the treatment of alopecia during the last six months AGA type 2-4. Exclusion criteria: Age under18 years, pregnancy, breastfeeding, History of malignant diseases, Taking any topical or systemic treatment during the study.
Intervention groups
Intervention group: The head area of the patients will be treated with CO2 laser three times with a one month interval, and minoxidil 15% will be used topically twice a day for three months. Control group: The head area of the patients will use minoxidil 15% twice a day topically for three months.
Main outcome variables
Hair density, side effects, satisfaction, tolerability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N50
Registration date:2024-07-17, 1403/04/27
Registration timing:prospective
Last update:2024-07-17, 1403/04/27
Update count:0
Registration date
2024-07-17, 1403/04/27
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
2024-07-20, 1403/04/30
Expected recruitment end date
2024-09-15, 1403/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the safety and efficacy of fractional CO2 laser in combination with topical minoxidil 15% compared to topical minoxidil 15% alone in the treatment of patients with androgenetic hair loss: a single-blind clinical trial study
Public title
Investigation of the safety and effectiveness of fractional CO2 laser in combination with topical minoxidil 15% in the treatment of patients with androgenetic hair loss.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not using topical or oral medication for the treatment of alopecia during the last six months
AGA type 2-4
Exclusion criteria:
Age under18 years
pregnancy
breastfeeding
History of malignant diseases
Taking any topical or systemic treatment during the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
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
Two of the dermatologists who are responsible for comparing the photos of the patients before and after the treatment do not know about the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of medical school - Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.049
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 starting the treatment and one month after the end of the treatment period (end of the fourth month)
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
At the time of the laser
Method of measurement
Questionnaire and visit
2
Description
satisfaction
Timepoint
satisfaction
Method of measurement
Satisfaction Questionnaire and visit
3
Description
Tolerability
Timepoint
At the time of the laser
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Intervention group: The head area of the patients will be treated with CO2 laser three times with a one month interval, and minoxidil 15% will be used topically twice a day for three months.
Category
Treatment - Other
2
Description
Control group: The head area of the patients will use minoxidil 15% twice a day topically for three months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center Clinic, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No. 4, Maryam Alley, South Kamraniye St.
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
floor 6th vice president of research and technology, corner of Qods St., Central University Organization, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 8663 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, 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 Kamraniye St.
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
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
No. 4, Maryam Alley, South Kamraniye St.
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@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 Kamraniye St.
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