Comparing the Effect of Subcision With and Without Carboxytherapy in the Treatment of Atrophic Acne Scars in Patients Referring to the Dermatology Clinic of Loghman-Hakim Hospital, Tehran in 2023
Design
This is a non-blinded randomized controlled clinical trial on 25 patients with atrophic acne scars. The intervention group receives treatment with Subcision and carboxytherapy, and the control group only receives Subcision. All patients receive both treatments on one side of the face and only receive Subcision on the other side. Random allocation software is used and the right and left sides of the face randomly receive one of these treatments. The results are compared after one and three months.
Settings and conduct
This study will be conducted in Loghman-e-Hakim Hospital. Patients are treated with Subcision. A tumescent solution is injected into the scar area and the subcutaneous fibrotic tissues are slowly separated by the blunt blade cannula. On one side of the face, 3 sessions of carboxytherapy are performed at intervals of 2 days.
Participants/Inclusion and exclusion criteria
All adult patients with rolling atrophic acne scars are included after written informed consent. Patients with active acne, active viral or bacterial infection, bleeding disorders, current use of systemic retinoid or during the preceding 12 months, hypertrophic scars, and hypersensitivity to anesthetic drugs are excluded.
Intervention groups
Twenty-five eligible patients are selected and divided into two groups, the right and left side of the face. One side of the face is randomly treated with carboxytherapy and Subcision and the other side only with Subcision. These two groups are compared with each other after one and three months after the treatment.
Main outcome variables
Changes in scar appearance one and three months after the treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230725058916N1
Registration date:2023-08-01, 1402/05/10
Registration timing:prospective
Last update:2023-08-01, 1402/05/10
Update count:0
Registration date
2023-08-01, 1402/05/10
Registrant information
Name
Sina Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3824 2668
Email address
sinamokhtari1996@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy of Subcision with and without carboxytherapy in the treatment of atrophic acne scars
Public title
Examining the benefits of combination treatment in acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients with atrophic rolling acne scars
Exclusion criteria:
Active acne
Active bacterial or viral infections
Bleeding disorders
Current use of systemic retinoids or during the last year
Hypertrophic scars
Hypersensitivity to anesthesia drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software is used to allocate the treatment groups into two groups of Subcision alone and Subcision and carboxytherapy
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Skin Research Center-Shahid Beheshti University of Medical Sciences
Street address
Skin Research Center, Mino Dead end Alley, Shahrdari St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.SBMU.SRC.REC.1401.019
Health conditions studied
1
Description of health condition studied
Atrophic acne scars
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Atrophic scar improvement
Timepoint
One and three months after treatment
Method of measurement
Comparison of photos before and after treatment, comments of the patient and the attending physicians (2 physicians) (Goodman and Baron's acne scar grading system)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receive both Subcision and carboxytherapy on one side of the face. First, a tumescent solution is injected into the acne scar area. Fibrotic tissues are slowly separated by the blunt blade cannula. Finally, the cannula entry area is bandaged. Three sessions of carboxytherapy are performed with a pressure of 275-320, and a volume of 50-70 cc of gas is injected using an insulin needle.
Category
Treatment - Other
2
Description
Control group: Patients only receive Subcision on the other side of the face
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The anonymous dataset is available for sharing with researchers upon a reasonable request. The study protocol, analysis, and results will be published in the form of research articles.
When the data will become available and for how long
The dataset is accessible 6 months after the results are published
To whom data/document is available
All researchers upon a reasonable request
Under which criteria data/document could be used
Systematic review and meta-analysis, for the researcher's own knowledge
From where data/document is obtainable
Corresponding author's email or the information mentioned for the person corresponding to update the state of the clinical trial
What processes are involved for a request to access data/document
After receiving the request, a decision is made after consulting with the research members and the decision to provide the data file to the researcher is announced to her/him.