Achievement of combination treatment with higher efficacy and lower side effects than previous treatment methods of acne scars.
Design
Phase 3 controlled randomized double-blind clinical trial with parallel groups design of 10 patients. For randomization , Simple randomization by coin tossing was used.
Settings and conduct
Ten patients with acne scars were entered to study. In these patients, subcision technique was randomly performed on one side of the face and subcision technique plus SVF on the opposite side of the face. The degree of neoclagenosis was evaluated by ultrasound before and 3 months after intervention. Recovery rate was assessed using a patient-based mental scoring system and visual evaluation of scars.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range of 20-50 years; Moderate and severe scars; Conscious consent for participation in the study
Exclusion criteria: Pregnancy and lactation; Malignancy
Intervention groups
Control: subcision technique on one side of the face
Case: subcision technique plus SVF on the opposite side of the face
Evaluation of the efficacy of SVF cells on the effect of subcision method in the treatment of acne scars; A double blind clinical trial
Public title
Effect of Svf and Subcision in Acne Scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-50 years
Moderate and severe acne scars
No treatment in 3months ago
Conscious consent to participate in the study
Exclusion criteria:
Pregnancy and lactation
Malignancy
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization and coin tossing methods were used. Performance of alone subcision method was considered as heads and combination therapy was considered as tails and random assignment was performed by tossing a coin.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants as to which side of the face the Svf injection was given.
A dermatologist who evaluates the outcome.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
NO.9, Bloc 446, Shirdam Town, Babaei Highway
City
Tehran
Province
Tehran
Postal code
1234567890
Approval date
2021-11-26, 1400/09/05
Ethics committee reference number
IR.IUMS.FMD.REC.1399.410
Health conditions studied
1
Description of health condition studied
Acne Scars
ICD-10 code
L70.8
ICD-10 code description
Other acne
Primary outcomes
1
Description
scar mental score
Timepoint
Before and 3 months after the intervention
Method of measurement
Patient Mental Scoring System, Patients are asked to rate the severity of scars seen on their face based on a 0 to 10 scoring comparison (0 without scars and 10 severe scars).