Conducting a clinical trial on amnion lyophilized allograft product in improving complications after fractional CO2 laser
Design
This study is conducted as a pilot on 30 patients with moderate and severe wrinkles. All patients are photographed by a digital camera before treatment and at each visit session. To determine the recovery rate and compare the two sides of the face, 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
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 30-60; Having moderate wrinkles on the face. Exclusion criteria: Pregnancy and breastfeeding; Active infection in face; Using any injectable fillers on the face in the last six months
Intervention groups
Intervention group: The patient will receive Fractional CO2 laser in three sessions with an interval of one month, and after the laser, 2 cc of the product will be sprayed on the face. Control group: The patient will receive Fractional CO2 laser in three sessions with an interval of one month, and after the laser, a restorative cream will be used.
Main outcome variables
The amount of wrinkles; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N45
Registration date:2024-06-19, 1403/03/30
Registration timing:prospective
Last update:2024-06-19, 1403/03/30
Update count:0
Registration date
2024-06-19, 1403/03/30
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
2024-06-20, 1403/03/31
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Conducting a clinical trial on amnion lyophilized allograft product in improving complications after fractional CO2 laser
Public title
Conducting a clinical trial on amnion lyophilized product in improving complications after laser
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30-60
Having middle wrinkles in face region
Exclusion criteria:
Pregnancy and breastfeeding
History of cancer
Patients with a new history of gel and Botox injections
People with Mental Disorders
Active infection in the face
Age
From 30 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome evaluator and data analyzer will not know the type of mask and treatment and will only examine the biometric data and photos of the patients. Therefore, the study will be double-blind.
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.1403.050
Health conditions studied
1
Description of health condition studied
Skin aging
ICD-10 code
L90.9
ICD-10 code description
Atrophic disorder of skin
Primary outcomes
1
Description
The amount of wrinkles
Timepoint
Before treatment and one month after the last session
Method of measurement
Visio face
Secondary outcomes
1
Description
side effects
Timepoint
in each session
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Intervention group: The patient will receive Fractional CO2 laser in three sessions with an interval of one month, and after the laser, 2 cc of the product will be sprayed on the face.
Category
Treatment - Other
2
Description
Control group: The patient will receive Fractional CO2 laser in three sessions with an interval of one month, and after the laser, a restorative cream will be used.
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 2665 7438
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