Title : Evaluation of clinical improvement of wrinkles in the whole facial skin using radiofrequency microneedling with adipose derived stem cell-conditioned medium
Evaluation the effect of conditioned media of adipose derived stem cells on repair of face wrinkles after micro needling
Design
This pilot study on 10 patients with moderate wrinkles done. At each session, after receiving adequate anesthetic, the wrinkles of the patients are treated with micro needling on both sides of the face. In each session immediately after the micro needling, one side of the patient's face, the conditioned media of ADSC, and the other side of the face, the physiologic serum was applied locally to the wrinkles area for one hour. This procedure is repeated 4 times at intervals of 4 weeks. All patients are photographed by digital camera before and after treatment. To determine the rate of improvement and compare two sides of the face at the end, patient photographs are reviewed by two blind dermatologist. Patient satisfaction is also recorded and the results are compared.
Settings and conduct
This design is done at the skin and stem cell research center of Tehran university of medical sciences and without the patient's knowledge, after the micro needling, one side of the face of conditioned media of ADSC and other side for blinding is used of the physiology serum in the wrinkles.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-60; 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
First intervention group: One side of the face is treated with micro needling and conditioned media of adipose derived stem cells in the topical position. Second intervention group: The other side of the face is treated as a control group with micro needling and physiologic serum.
Main outcome variables
The amount of wrinkles; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N3
Registration date:2021-06-06, 1400/03/16
Registration timing:prospective
Last update:2021-06-06, 1400/03/16
Update count:0
Registration date
2021-06-06, 1400/03/16
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
2021-07-21, 1400/04/30
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Title : Evaluation of clinical improvement of wrinkles in the whole facial skin using radiofrequency microneedling with adipose derived stem cell-conditioned medium
Public title
Evaluation of clinical improvement of conditioned media of adipose derived stem cells in the treatment of wrinkles in the whole facial skin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60 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 20 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
A half face will be considered as the control group and one half as an intervention group.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In each session, immediately after the micro needling on one side of the face, the conditioned media of adipose derived stem cells and the other side of the face saline solution is used topically on the wrinkles.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Keshavarz blvd, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2020-11-14, 1399/08/24
Ethics committee reference number
IR.TUMS.VCR.REC.1399.601
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
One week after session
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Control group: (Other side of face) After sufficient anesthesia, first treatment with micro needling, and then physiological serum is applied topically to the site of the wrinkles for one hour. This procedure is repeated 4 times with intervals of 4 weeks. .
Category
Treatment - Other
2
Description
Intervention group: One side of the face after being anesthetized, is first treated with micro needling, and then adipose conditioned media of adipose derived stem cells is applied topically to the wrinkles for one hour. This procedure is repeated 4 times with intervals of 4 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, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
Dr_nilforoush@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
4No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
Dr_nilforoush@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and Stem cell Research Center of 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, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
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
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
Dr_nilforoush@yahoo.com
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, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
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