Evaluation of safety and effectiveness of liposomal formulations of amniotic membrane in treatment skin aging after laser rejuvenation (phase I / II clinical trial)
Evaluation of safety and effectiveness of liposomal formulations of amniotic membrane in treatment of skin aging after laser rejuvenation (phase I / II clinical trial)
Design
Clinical trial with control and intervention groups, parallel groups, single-blind, non-randomized, phase 1-2
Settings and conduct
To evaluate this product, patients receiving laser for skin aging treatment at the Skin and Stem Cell Research Center of Tehran University of Medical Sciences will be evaluated. The product will be evaluated topically in both lyophilized and liposomal lyophilized forms. Patients will undergo clinical evaluations and the restored range will be evaluated. Patients are not aware of the type of liposomal or non-liposomal product.
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
Control group: 10 The patient uses the non-liposomal product immediately after laser rejuvenation in three sessions with an interval of one month. Intervention group: 10 The patient uses the liposomal product immediately after laser rejuvenation in three sessions with an interval of one month.
Main outcome variables
The amount of wrinkles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N25
Registration date:2023-02-18, 1401/11/29
Registration timing:prospective
Last update:2023-02-18, 1401/11/29
Update count:0
Registration date
2023-02-18, 1401/11/29
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
2023-02-20, 1401/12/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and effectiveness of liposomal formulations of amniotic membrane in treatment skin aging after laser rejuvenation (phase I / II clinical trial)
Public title
Evaluation of liposomal formulations of amniotic membrane in treatment skin aging after laser rejuvenation
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
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The data analyst will be blinded and will not know the control and treatment groups. The patient will not be aware of being in the control and test groups, and the product of each group will be used in the same form.
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
Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.539
Health conditions studied
1
Description of health condition studied
skin aging
ICD-10 code
L90.9
ICD-10 code description
Atrophic disorder of skin, unspecified
Primary outcomes
1
Description
The amount of wrinkles
Timepoint
Before treatment and six month after the last session
Method of measurement
Visio face
Secondary outcomes
1
Description
Inflammation
Timepoint
After each session of treatment
Method of measurement
Questionnaire and visit
2
Description
Intensity of pain
Timepoint
Treatment time
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Control group: 10 patients use Amnion's non-liposomal product (Zist Sakht Bonyan Pars company) topically immediately after fractional CO2 laser rejuvenation in three sessions with an interval of one month.
Category
Treatment - Other
2
Description
Intervention group: 10 patients use amnion liposomal product (Zist Sakht Bonyan Pars company) topically immediately after fractional CO2 laser rejuvenation in three sessions with an interval of one month.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center Clinic of the University of Science Tehran Medicine
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
Akbar Fatuhi
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 8163 3698
Email
ir.ac.tums@vcr
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
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
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
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, Ban Best Maryam, South Kamraniyeh
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
com.gmail@sonazarebio
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