Evaluation and comparison of the effect of PRP and PRP with microneedling in the treatment of striae distensae
Design
This phase 1 study is performed on 30 patients with striae. Each patient is treated with PRP on the right half of the body and PRP with microneedling on the left side of the body for four sessions over 8 weeks, and their lesions are photographed before and after treatment, as well as patient satisfaction. Each party is evaluated from the treatment process (dissatisfied, almost satisfied, very satisfied) and also their histopathological results (thickness of epidermis, collagen and elastic fiber) before and three months after the treatment period and side effects are evaluated.
Settings and conduct
This project is performed in the Dermatology and Stem Cell Research Center of Tehran University of Medical Sciences and in the intervention groups, PRP on the right half of the body and PRP with microneedling on the left side of the body are transplanted.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of striae distensae based on the diagnosis of a dermatologist, patients' willingness to participate in the study; aged between 18 to 50. Exclusion criteria: use of any treatment to eliminate striae in three months In the past, the presence of lesions and skin diseases such as skin cancer, wart, skin infection.
Intervention groups
Intervention group: Patients treated with PRP with microneedling on the left side of the body. Control group: Patients treated with PRP are placed on the right side of the body.
Main outcome variables
striae surface; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N11
Registration date:2022-04-26, 1401/02/06
Registration timing:registered_while_recruiting
Last update:2022-04-26, 1401/02/06
Update count:0
Registration date
2022-04-26, 1401/02/06
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
2022-04-19, 1401/01/30
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effect of PRP and PRP with microneedling in the treatment of striae distensae
Public title
Evaluation of the effect of PRP and PRP microneedling in the treatment of striae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of striae distensae based on the diagnosis of a dermatologist
Patient satisfaction with the study
Age less than 50 years and more than 18 years
Exclusion criteria:
Use any treatment to eliminate striae in the last three months
Existence of skin lesions and diseases such as skin cancer
wart
Skin infection
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not know the type of treatment. Therefore, the study will be conducted in one blinds.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-04-07, 1400/01/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.029
Health conditions studied
1
Description of health condition studied
striae distensae
ICD-10 code
L90.6
ICD-10 code description
Atrophic disorder of skin, unspecified
Primary outcomes
1
Description
striae size
Timepoint
before and 1 month after the intervention
Method of measurement
biometry
Secondary outcomes
1
Description
Side effects
Timepoint
One week after treatment
Method of measurement
Questionnaire and visit
2
Description
Patient Satisfaction
Timepoint
one and three months after treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Patients treated with PRP with microneedling on the left side of the body for four sessions over 8 weeks.
Category
Treatment - Other
2
Description
Control group: Patients treated with PRP are placed in the right half of the body for four sessions over 8 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 2665 7438
Email
Nilforoosh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Skin and Stem Cell Research Center, 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 2665 7438
Email
Nilforoosh@sina.tums.ac.ir
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, 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 Kamraniyeh Street, Tehran
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
Masoumeh Roohaninasab
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
masoomehrohani@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 Kamraniyeh Street, Tehran
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