Determination of the effectiveness of nanofat grafting in comparison with microneedling in the treatment of striae
distensae
Design
Phase 3, parallel group, clinical trial, with consecutive sampling, including 20 patients, single blinded, computerized randomized with permuted blocks
Settings and conduct
The study is conducted in the Imam Reza laser clinic of Shiraz University of Medical Sciences randomly with nanofat grafting in one side (one session at the beginning of study) and microneedling in the other side (3 session once monthly). The patients are assessed at the beginning of treatment, monthly visits for microneedling and 6 months after the first visit by photography and colorimetry. The investigator is blind to the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients of 18 to 60 years of age; bilateral striae distensae (alba and rubra); site on the abdomen, buttock, calves, thighs, and arms
Exclusion criteria: pregnancy; lactation; body mass index ≤ 22; history of nickel hypersensitivity; history of treatment for striae in the recent one year; history of hypertrophic scar or keloid formation; active infections on the study area; severe underlying internal diseases; history of hypercoagulation states; Consumption of immunosuppressant drugs, systemic retinoids, corticosteroids, anabolic steroids in the recent 2 months; history of allergy to any ingredient of tumescent anesthetic solution; history of abdominoplasty; scar on the fat donor site; history of Cushing syndrome; polycystic ovary syndrome; body dysmorphic disorder
Intervention groups
Intervention group: Nanofat graft in the striae of one side of body one session at the beginning of study
Control group: Microneedling of the striae of one side of body 3 session monthly
Main outcome variables
Clinical improvement of striae, measured by Global aesthetic improvement scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140212016557N10
Registration date:2022-01-22, 1400/11/02
Registration timing:registered_while_recruiting
Last update:2022-01-22, 1400/11/02
Update count:0
Registration date
2022-01-22, 1400/11/02
Registrant information
Name
Mozhdeh Sepaskhah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 712125239
Email address
sepaskhah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of nanofat graft with microneedling in the clinical improvement of striae distensae
Public title
Effect of nanofat injection in the treatment of stretch marks
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients of 18 to 60 years of age
bilateral striae distensae (alba and rubra)
site on the abdomen, buttock, calves, thighs, and arms
Exclusion criteria:
pregnancy
lactation
body mass index less than or equal to 22
history of nickel hypersensitivity
history of treatment for striae in the recent one year
history of hypertrophic scar or keloid formation
active infections on the study area
severe underlying internal diseases
history of hypercoagulation states
Consumption of immunosuppressant drugs, systemic retinoids, corticosteroids, and anabolic steroids in the recent 2 months
history of allergy to any ingredient of tumescent anesthetic solution
history of abdominoplasty
scar on the fat donor site
history of Cushing syndrome
history of polycystic ovary syndrome
body dysmorphic disorder
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:
20
More than 1 sample in each individual
Number of samples in each individual:
2
One side of the body is allocated in the nanofat grafting group and the other side in the microneedling group.
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomized using permuted block randomization (size of each block: 4), in individual units, using random allocation software. The output of software is a table that determines the right or left side undergoes nanofat grafting.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the different treatment methods in two sides, the participants cannot be blinded. Principle investigator, and care provider physician are also aware of the the side undergoing nanofat grafting. But, outcome assessors are not aware of the side undergoing nanofat grafting in each patient.
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
Shiraz University of Medical Sciences, Zand St., Shiraz. Iran
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2021-12-20, 1400/09/29
Ethics committee reference number
IR.SUMS.MED.REC.1400.501
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
Clinical improvement of striae
Timepoint
The patients will be assessed in 3 monthly visits for microneedling, and 6 months after the first visit.
Method of measurement
Global aesthetic improvement scale, measured as: Grade 0: Worsening of lesions; Grade 1: 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
Striae size reduction
Timepoint
3 monthly visits for microneedling, and 6 months after the first visit
Method of measurement
Percentage of striae width reduction
2
Description
Striae color
Timepoint
At the beginning of treatment, 3 monthly visits for microneedling, and 6 months after the first visit
Method of measurement
Pigment index is measured by colorimetric device
3
Description
Dermoscopic features of striae
Timepoint
At the beginning of treatment, 3 monthly visits for microneedling, and 6 months after the first visit
Method of measurement
Dermatoscopic features like color, vascularity, width, and texture of striae