Comparison of the effect of combination microneedling and topical basic fibroblast growth factor with microneedling alone in the improvement of stria distensae
Comparison of the effect of combination microneedling and topical BFGF with microneedling alone in the improvement of stria distensae
Design
This study is a assessor-blinded randomized controlled, pilot clinical trial with parallel pattern.
Settings and conduct
The patients will be enrolled from the patients who are referred to outpatient dermatology clinics of Shahid Faghihi and Imam Reza clinics by consecutive sampling method.
Participants/Inclusion and exclusion criteria
The inclusion critera of the study will be patients between 18 and 60 years old.
The exclusion criteria of the study will be patients younger than 18 years or older than 60 years, pregnant or lactating women, diabetic, hypertension, hypothyroidism, hyperthyroidism, immunosuppressed patients, also patients who recieved stria treatment 3 months ago or have infection on the stria.
Intervention groups
Group A will recieve microneedling monthly with topical bFGF for three months with a frequency of twice daily and group B will be undergo microneedling alone for three months with one-month intervals.
Main outcome variables
Clinical improvement of striae with global aesthetic improvement scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220924056033N1
Registration date:2022-10-07, 1401/07/15
Registration timing:prospective
Last update:2022-10-07, 1401/07/15
Update count:0
Registration date
2022-10-07, 1401/07/15
Registrant information
Name
Rahil Hamedpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 4997
Email address
anisa1370@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of combination microneedling and topical basic fibroblast growth factor with microneedling alone in the improvement of stria distensae
Public title
Effect of microneedling and topical basic fibroblast growth factor in treatment of stretch marks
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patents between 18 and 60 years old
Exclusion criteria:
Pregnant women
Lactating women
Diabetic
Hypertension
Hypothyroidism
Hyperthyroidism
Immunosuppressed patients
Patients who recieved stria treatment 3 months ago or have infection on the stria
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The study groups are divided into two groups A and B using random allocation software using the permutation block method. Group A is assigned to microneedling and local fibroblast growth factor intervention group, and group B is assigned to microneedling intervention alone. Considering that patients enter the plan from number 1 to 30 in order; The colleague entered the study patients in the order of referral in the relevant intervention group and this order is maintained until the end of the study. Dark colored envelopes are used to hide the order of randomization codes.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this plan, the patients are aware of the type of intervention because patients in one group (group A) receive an invasive intervention (microneedling) along with a drug (local fibroblast growth factor) that cannot be used as a placebo, and the other group (group A) B) receives only microneedling. However, the clinical assessment is not aware of the type of study and only recognizes patients with labels A and B, and the design is assessor blind in this regard.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street, Shahid Faghihi hospital
City
Shiraz
Province
Fars
Postal code
7173776773
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.SUMS.MED.REC.1401.326
Health conditions studied
1
Description of health condition studied
Stria distensa
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae
Primary outcomes
1
Description
Clinical improvement stria
Timepoint
Patients will be visited 4 times, 0, 1, 2, 5 month
Method of measurement
The GAIS(Global Aesthetic Improvement Scale) is measured as follows:Grade 0: worsening of lesions Grade1: No change (< 25% improvement)Grade 2: Improved (25-50% improvement)Grade 3: Much improved (51-75% improvement)Grade 4: Very much improved (76-100% improvement)
Secondary outcomes
1
Description
Stria size reduction
Timepoint
Patients will be visited 4 times, 0, 1, 2, 5 month
Method of measurement
Rate of width reduction (%)=Baseline width-Follow upwidth/Baseline width ×100
2
Description
Stria color
Timepoint
Patients will be visited 4 times, 0, 1, 2, 5 month
Method of measurement
Melanin index is measured bySkinColorCatch colorimeter(Delphin, Finland) and is presentedas average of .3 points measure
3
Description
Patient satisfaction
Timepoint
Patients will be visited 4 times, 0, 1, 2, 5 month
Method of measurement
Patient satisfaction is assessed by a 5point scale: 4: Extremely satisfied3: Very satisfied 2: satisfied 1:Slightly satisfied 0: Not satisfied
Intervention groups
1
Description
Intervention group: Combination of microneedling and Basic Fibroblas Growth Factor (BFGF) in the treatment of stria distensae (each month three sessions)
Category
Treatment - Surgery
2
Description
Control group: Use of microneedling alone in the treatment of stria distensae (each month three sessions)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi hospital
Full name of responsible person
Rahil Hamedpour
Street address
Zand street, Shahid Faghihi hospital
City
Shiraz
Province
Fars
Postal code
7173776773
Phone
+98 71 3235 4997
Email
anisa1370@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahtab Memarzadeh
Street address
Zand street, Shiraz university medical science
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Rahil Hamedpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Zand street, Shahid Faghihi hospital
City
Shiraz
Province
Fars
Postal code
7173776773
Phone
+98 71 3234 4997
Email
anisa1370@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rahil Hamedpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Zand street, Shahid Faghihi hospital
City
Shiraz
Province
Fars
Postal code
7173776773
Phone
+98 71 3234 4997
Email
anisa1370@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rahil Hamedpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Zand street, Shahid Faghihi hospital
City
Shiraz
Province
Fars
Postal code
7173776773
Phone
+98 71 3234 4997
Email
anisa1370@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD