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Comparison of the Effectiveness of Microneedling Therapy with CO2 Fractional Leaser therapy for theTreatment of Striae Distensa in Patients with Striae Distensae

Protocol summary

Study aim
Comparison of the efficacy of microneedling versus fractional leaser in treatment of striae
Design
The study will be performed a single-blind clinical trial on 40 patients with striae. In each patient, similar striae in shape and size and almost symmetrically at a surface of 5 x 5 cm2 will be selected, and one side of the patient will be treated randomly by CO2 fractional laser method and the other side will be treated by microneedling method.
Settings and conduct
Shahid Dr. Faghihi Hospital, Each side will be randomly assigned to the treatment method using the "coin flip” method. Evaluators are blind. The study is one-way blind
Participants/Inclusion and exclusion criteria
In this study will be selected patients older than 15 and less than 50 years with striae including striae alba and striae rubra on abdomen, buttock, and flank lesions who had not received previous treatment for SD in the last two months; Pregnant women, breastfeeding mothers, patients taking immunosuppressive drugs, patients who are prone to forming keloid, patients who have received previous treatment for SD in the past 2 months, patients with Cushing's Syndrome or connective tissue diseases, patients who have vitamin derivatives A used up to 2 months prior to the study, patients who had a history of systemic or topical steroid use, filler injection, abdominal dermabrasion, or laser skin resurfacing in the SD area for the past 6–12 months, patients who had striae on their chest or arm, and patients with defective blood supply or diabetes mellitus or wound healing disorders.
Intervention groups
Each patient will be hypothetically divided into the right and left halves. One side of the patient will be treated with microneedling method and the other side will be treated with fractional CO2 laser method.
Main outcome variables
visual-analogue scale Patients satisfaction score Dermatologist assessed improvement Lesions size

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120909010795N5
Registration date: 2021-05-31, 1400/03/10
Registration timing: retrospective

Last update: 2021-05-31, 1400/03/10
Update count: 0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
Nasrin Saki
Name of organization / entity
Dermatology Department,Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 19049
Email address
sakina@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-07, 1398/01/18
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Microneedling Therapy with CO2 Fractional Leaser therapy for theTreatment of Striae Distensa in Patients with Striae Distensae
Public title
Comparison of the Effectiveness of Microneedling Therapy with CO2 Fractional Leaser therapy for theTreatment of Striae Distensa in Patients with Striae Distensae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 15 and less than 50 years Patients with striae including striae alba and striae rubra on abdomen, buttock, and flank lesions Patients had not received previous treatment for striae distance in the last two months
Exclusion criteria:
Pregnant women breastfeeding mothers Patients taking immunosuppressive drugs Patients who are prone to forming keloid Patients who have received previous treatment for SD in the past 2 months Patients with Cushing's Syndrome or connective tissue diseases Patients who have vitamin derivatives A used up to 2 months prior to the study Patients who had a history of systemic or topical steroid use, filler injection, abdominal dermabrasion, or laser skin resurfacing in the striae distance area for the past 6–12 months Patients who had striae on their chest or arm Patients with defective blood supply or diabetes mellitus or wound healing disorders
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 40
More than 1 sample in each individual
Number of samples in each individual: 2
Right and left (hypothetical line)
Randomization (investigator's opinion)
Randomized
Randomization description
Each side will be randomly assigned to the treatment method using the "coin flip” method. The microneedling method will be performed with the probability of a "Tail" and the fractional CO2 laser method with the probability of a "Head".
Blinding (investigator's opinion)
Single blinded
Blinding description
Treatment evaluations and scorings will be provided by two non-therapeutic dermatologists. Due to the different nature of treatment, the therapist and the patient are not blind, but the evaluators are blind and unaware of the treatment process.
Placebo
Not used
Assignment
Parallel
Other design features
Two common treatment modalities are discussed in this study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.SUMS.MED.REC.1397.534

Health conditions studied

1

Description of health condition studied
Striae rubra- striae alba
ICD-10 code
L90.6
ICD-10 code description
Linear dermal scars accompanied by epidermal atrophy that affects skin that is subjected to continuous streching. They usually do not cause any significant medical problems, only cosmetic problems.

Primary outcomes

1

Description
Dermatologist assessed improvement score
Timepoint
At baseline and 1 and 6 months after treatment
Method of measurement
Photography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: It will be treated with microneedling method on a monthly basis.
Category
Treatment - Other

2

Description
Intervention group 2: It will be treated with fractional CO2 laser method on a monthly basis.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Faqhihi Hospital
Full name of responsible person
Dr. Nasrin Saki
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Fax
Email
faghihihsp@sums.ac.ir
Web page address
https://faghihi.sums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3230 5410
Email
ghasemiy@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
Farzaneh Rahimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3235 2559
Email
raahimi.1365@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Nasrin Saki
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3235 2559
Email
sakina@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Rahimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3235 2559
Email
raahimi.1365@gmail.com

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
Yes - There is 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
Demographic data and clinical trial results
When the data will become available and for how long
6 months later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
Sending email to the researchers
What processes are involved for a request to access data/document
Sending the request via the email
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