A comparative study of the effectiveness of Nanofat - PRP - Exosome therapy in the treatment of atrophic burn scars in patients treated with fractional CO2 laser: a double-blind randomized clinical trial
Comparing the effectiveness of treatment methods, including Nanofat, Nanofat with PRP, and Nanofat with Exosome, in atrophic burn scars treated with fractional CO2 laser.
Design
A clinical trial with a control group, using parallel groups, double-blind, randomized, phase 1 trial involving 10 patients. For randomization, a lottery system is used to determine the injection site.
Settings and conduct
10 patients with atrophic burn scars will be selected. All patients have already undergone treatment with CO2 fractional laser. The atrophic burn scar areas of all patients are divided into four parts. In one area, nanofat injection is administered. In another area, a combination of nanofat and platelet-rich plasma is used, while in the third area, a combination of nanofat and exosome is applied. The fourth area remains untreated. All patients receive reinjections after one month. Interventions will be conducted at the Skin and Stem Cell Research Center. The patient under study and the two evaluating dermatologists are unaware of the type of injection performed in each area.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 10 patients diagnosed with atrophic burn scars treated with fractional CO2 laser but did not fully recover.
Exclusion criteria:
1.Age less than 18 years or more than 50 years.
2.Atrophic scars created within the last 6 months.
3.Undergoing therapeutic intervention for atrophic scars within the last month, except fractional CO2 laser.
4.Presence of bleeding and coagulation disorders.
5.Pregnancy.
6.Breastfeeding.
Intervention groups
Fractional co2 laser
Intradermal injection
Exosome: Exosomes are prepared from the conditioned medium of stem cells by ultracentrifugation.
Nanofat
Platelet-rich plasma
Main outcome variables
Injection of exosome, nanofat and prp has a positive effect on atrophic burn scars.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231211060333N1
Registration date:2024-04-26, 1403/02/07
Registration timing:registered_while_recruiting
Last update:2024-04-26, 1403/02/07
Update count:0
Registration date
2024-04-26, 1403/02/07
Registrant information
Name
Hanieh Pourazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8826 6879
Email address
porazarhani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness of Nanofat - PRP - Exosome therapy in the treatment of atrophic burn scars in patients treated with fractional CO2 laser: a double-blind randomized clinical trial
Public title
A comparative study of the effectiveness of Nanofat - PRP - Exosome therapy in the treatment of atrophic burn scars in patients treated with fractional CO2 laser: a double-blind randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been treated with fractional CO2 laser for the diagnosis of atrophic burn scars, but have not fully recovered.
Exclusion criteria:
Ages less than 18 years old or more than 50 years old
Atrophic scar created in the last 6 months
Conducting therapeutic intervention for atrophic scar in the last one month, except fractional CO2 laser
pregnancy
breastfeeding
Bleeding and coagulation disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of the injection type in each scar area for each patient is determined by lottery. Initially, one of four scar areas is chosen through a random draw (e.g., area number 3 is selected). Then, one of four injection types (exosome + nanofat, PRP + nanofat, exosome + PRP + nanofat, or nanofat alone) is selected for the chosen area through another lottery (e.g., PRP + nanofat is chosen). The selected injection is administered to the selected area, and subsequent injections follow in numerical order for the remaining areas (e.g., if PRP + nanofat is injected in area #3, then exosome + PRP + nanofat is injected in area #4, nanofat in area #1, and finally nanofat + exosome in area #2). This order remains consistent for each patient throughout the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient under study and the two dermatologists evaluating the atrophic scar lesions are not aware of the type of injection performed in each area.
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
Sattarkhan St, Niyayesh St, Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2023-09-11, 1402/06/20
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.329
Health conditions studied
1
Description of health condition studied
Atrophic Burn Scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
The healing rate of atrophic burn scars
Timepoint
The evaluation of patients will be conducted in three stages:1.At the beginning of the study and before the commencement of clinical interventions involving intralesional injections.2.Before receiving the second round of intralesional injections.3.Two months after the end of the treatment period.
Method of measurement
Scale scar vancouver and biometric evaluations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: nanofat+exosome
Category
Treatment - Drugs
2
Description
Intervention group: nanofat+ prp
Category
Treatment - Drugs
3
Description
Intervention group: nanofat+ exosome+prp
Category
Treatment - Drugs
4
Description
Control group: nanofat
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh Alzahra Hospital
Full name of responsible person
Hanieh Pourazari
Street address
23 St, Yousef Abad
City
Tehran
Province
Tehran
Postal code
3311114339
Phone
+98 21 8871 7272
Fax
Email
porazarhani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hanieh pourazari
Street address
Hemmat Highway, Iran Univercity of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1021
Email
porazarhani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?