Comparison of the therapeutic response of both PRP and 15% AHA versus 15% AHA alone in patients with facial wrinkles.
Design
Randomized clinical trial without blinding, phase 3, with cross-groups on 60 patients
Settings and conduct
This study will be performed in the dermatology clinic of Sina Hospital in Tabriz. There will be no blinding.
Participants/Inclusion and exclusion criteria
inclusion criteria were age between 18 to 45 years and satisfaction to participate in the study. Exclusion criteria were platelet disorder or blood clots, chronic liver disease, history of drug treatment with bleeding or clotting mechanisms, pregnancy and cosmetic treatments in the past 6 months.
Intervention groups
Intervention group: Patients will receive 15% alpha-hydroxy acid overnight topically with platelet-rich plasma injection every two months for 6 months.
Control group: Patients will receive 15% alpha-hydroxy acid topically overnight for 6 months.
Main outcome variables
Intensity of wrinkles, degree of tissue healing and homogeneity of facial skin, patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140705018373N5
Registration date:2020-11-11, 1399/08/21
Registration timing:registered_while_recruiting
Last update:2020-11-11, 1399/08/21
Update count:0
Registration date
2020-11-11, 1399/08/21
Registrant information
Name
Mohamad Reza Ranjkesh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 5061
Email address
ranjkeshm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic response of both PRP and 15% AHA versus 15% AHA alone in patients with facial wrinkles
Public title
Effect of both PRP and 15% AHA versus 15% AHA alone on facial wrinkles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 45 years
Satisfaction to participate in the study
Exclusion criteria:
Platelet disorder or blood clots
Chronic liver disease
Autoimmune diseases
History of drug treatment with bleeding or clotting mechanisms,
Having cosmetic treatments in the past 6 months
Pregnancy
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization done using the file number of patients by site www.random.org and the Gaussian order. According to the study method, all patients will receive 15% AHA treatment and will be added in a PRP group. The cost of 15% AHA is part of the treatment routine, but the cost of PRP will be done in one group from the place of study costs. Therefore, additional costs are not borne by patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Sina hospital, between Hafez and Shahid-Montazeri square, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2020-09-28, 1399/07/07
Ethics committee reference number
IR.TBZMED.REC.1399.698
Health conditions studied
1
Description of health condition studied
Facial wrinkles
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Facial wrinkles severity
Timepoint
Initiation of the study, 1, 3 and 6 months after the intervention
Method of measurement
Wrinkle Severity Rating Scale
2
Description
Degree of tissue healing and homogeneity of facial skin
Timepoint
Initiation of the study, 1, 3 and 6 months after the intervention
Method of measurement
Skin Homogeneity and Texture Scale
3
Description
Patient satisfaction
Timepoint
6 months after the intervention
Method of measurement
Asking from patients on a scale of 1 to 5 range from very dissatisfied to very satisfied
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive 15% alpha-hydroxy acid overnight topically with platelet-rich plasma injection every two months for 6 months.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive 15% alpha-hydroxy acid topically overnight for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiee
Street address
Floor 3, Unit 2, Tabriz university of medical sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3335 7310
Email
samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.