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Comparison of the therapeutic effect of the combination of Erbium YAG laser and stromal vascular fraction (SVF), the combination of Erbium YAG laser and platelet-rich plasma (PRP) and Erbium YAG laser alone in the treatment of striae

Protocol summary

Study aim
Comparison of the therapeutic effect of the combination of Erbium YAG laser and stromal vascular fraction (SVF), the combination of Erbium YAG laser and platelet-rich plasma (PRP) and Erbium YAG laser alone in the treatment of striae
Design
Clinical trial with control group, with parallel groups, double-blind, randomized with sealed envelopes, phase 2-3 on 10 patients (30 lesions)
Settings and conduct
In this study, 10 patients with at least three striae will be treated with Erbium YAG Laser in one session. Then, in the same session, one side is randomly injected with SVF, one side is injected with PRP, and the third side is injected with placebo. Injections are done with syringes of the same shape and color, and the patient, as well as the doctor evaluating the results and the statistician are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The diagnosis of stria distensa based on the diagnosis of a dermatologist, Age less than 50 years and more than 18 years Exclusion criteria: Using any treatment method to remove striae in the last three months, Presence of lesions and skin diseases such as skin cancer or infections, Presence of collagen vascular diseases, Pregnancy and lactation, Using steroids or immunosuppressive drugs
Intervention groups
3 groups: combination of Erbium YAG laser and stromal vascular fraction (SVF), the combination of Erbium YAG laser and platelet-rich plasma (PRP) and Erbium YAG laser alone
Main outcome variables
Examining the level of effectiveness based on the Vancouver scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220322054341N2
Registration date: 2023-01-20, 1401/10/30
Registration timing: registered_while_recruiting

Last update: 2023-01-20, 1401/10/30
Update count: 0
Registration date
2023-01-20, 1401/10/30
Registrant information
Name
masoumeh roohaninasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2421
Email address
rohaninasab.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-14, 1401/10/24
Expected recruitment end date
2023-02-09, 1401/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of the combination of Erbium YAG laser and stromal vascular fraction (SVF), the combination of Erbium YAG laser and platelet-rich plasma (PRP) and Erbium YAG laser alone in the treatment of striae
Public title
The effect of erbium laser in striae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The diagnosis of stria distensa based on the diagnosis of a dermatologist Age less than 50 years and more than 18 years
Exclusion criteria:
Using any treatment method to remove striae in the last three months Presence of lesions and skin diseases such as skin cancer or infections Presence of collagen vascular diseases Pregnancy and lactation Using steroids or immunosuppressive drugs
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 10
More than 1 sample in each individual
Number of samples in each individual: 3
Each patient must have at least three striae
Randomization (investigator's opinion)
Randomized
Randomization description
After being selected by available method, lesions are divided into 3 groups by simple randomization, so that among 30 sealed bags, one bag will be randomly selected for each lesion. Each bag contains the letter a, b, or c.
Blinding (investigator's opinion)
Double blinded
Blinding description
The injection of stromal vascular fraction (SVF), platelet-rich plasma (PRP) and normal saline was done with syringes of the same shape, the contents of which are not known, and the patient does not know which treatment group he is in. Also, the doctor evaluating the results and the statistician are blinded to the treatment group of the patient.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of School of Medicine, Iran University of medical sciences
Street address
School of medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-01-17, 1401/10/27
Ethics committee reference number
IR.IUMS.FMD.REC.1401.510

Health conditions studied

1

Description of health condition studied
striae distensae
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae

Primary outcomes

1

Description
Pigmentation (color of the lesion)
Timepoint
3 months after the treatment
Method of measurement
Biometry with Colorimeter 4000, Multi Probe Adaptor System 5 (MPA5)

2

Description
Elasticity of the skin
Timepoint
3 months after the treatment
Method of measurement
Biometry with Cutometer, Multi Probe Adaptor System 580 (MPA580)

Secondary outcomes

1

Description
Patient satisfaction
Timepoint
3 months after the treatment
Method of measurement
Based on patient global assessment score

2

Description
Complications
Timepoint
3 months after the treatment
Method of measurement
Using a checklist containing treatment complications including pain, erythema and edema

Intervention groups

1

Description
Intervention group 1: combination of erbium Yag laser and intralesional injection of stromal vascular fraction (SVF). Erbium YAG laser usually selectively targets hydrous tissue with light of 2940 nm wavelength, and the residual thermal damage in the dermis leads to the accumulation and regeneration of collagen. SVF preparation: Mesenchymal stem cells are obtained by aspirating 20 to 40 cc of fat from the human thigh or abdomen during a surgical procedure (3 cm incision). The lipoaspirate is first washed thoroughly in phosphate-buffered saline before undergoing enzymatic digestion with collagenase to obtain a single cell suspension. After digestion, the centrifuged cell pellet (referred to as the Stromal Vascular Fraction (SVF)) is resuspended in StemMACS™ MSC Expansion Media before being serially filtered through 100-µm and then 40-µm nylon filters and the mononuclear cell fraction The cell sample is counted and cultured in StemMACS MSC Expansion Media. MSCs will adhere to plastic surfaces within 24 hours, after which the media should be replaced with fresh StemMACS MSC Expansion Media. 2-3 cc of the prepared solution SVF are injected subcutaneously at one centimeter intervals using a 1cc syringe.
Category
Treatment - Other

2

Description
Intervention group 2: combination of erbium Yag laser followed by intralesional injection of platelet-rich plasma (PRP). Platelet-rich plasma: First, the anticoagulant drug is added with a 20-ml syringe at a ratio of 1 to 10 (one milliliter of anticoagulant per ten milliliters of the patient's blood sample). A 50-ml blood sample is then drawn from the patient's internal cubital vein. Time is given for 10 seconds to ensure that the blood sample mixes with the anticoagulant drug. The tubes containing the above substance are centrifuged at 3000 rpm for 4 minutes. After centrifugation, there are three parts in the tube: a plasma part with few platelets, a tissue part and a red blood cell part. Since PRP is a combination of tissue and plasma, the red blood cells are separated from the kits. For final concentration, the separate parts containing PPP and buffy coat are centrifuged again at 3000 rpm for 4 minutes. The remaining PRP is then aspirated from each test tube and activated by adding calcium chloride (0.1 ml per 0.9 ml PRP) to finally obtain 6 ml of active PRP.
Category
Treatment - Other

3

Description
Intervention group 3: Combination of erbium Yag laser followed by intralesional injection of Normal Saline.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Rohaninasab
Street address
Skin and Stem Cell Research Center of Tehran University of Medical Sciences, Maryam dead end, South Kamaranieh Street
City
Tehran
Province
Tehran
Postal code
1998718444
Phone
+98 21 2665 7541
Fax
Email
info@skinstemcell.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforooshzadeh
Street address
Maryam Dead End, South Andarzgo Blvd, Kamraniyeh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2665 7541
Fax
Email
info@skinstemcell.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 of 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
Iran University of Medical Sciences
Full name of responsible person
Masoumeh Roohaninasab
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Rasule akram hospital, niyayesh ave, sattarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2421
Fax
Email
rohaninasab.m@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Roohaninasab
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 7341
Email
masoomehrohani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zeinab Mahdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 7341
Email
zb.mahdi@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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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