Autologous Fat Graft Harvesting, SVF-gel Preparation and FillingNCT06116162
Comparison of SVF-gel Filling and CO2 Fractional Laser on Atrophic Acne Scar Treatment
A study testing SVF-gel Filling and CO2 fractional laser in people with Autologous Fat Graft Harvesting, SVF-gel Preparation and Filling and CO2 Fractional Laser Treatment by Using Acupulse Device, run by Xijing Hospital at 2 sites in China.
Trial summary
Background Adipose extracellular matrix/stromal vascular fraction gel（SVF-gel）, which contains adipose-derived stem cells, endothelial cells, smooth muscle cells, pericytes, and other cell components. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Autologous Fat Graft Harvesting, SVF-gel Preparation and Filling, CO2 Fractional Laser Treatment by Using Acupulse Device
- What is being tested?
- SVF-gel Filling and CO2 fractional laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jan 2021to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Acne scar patients with severity of moderate to severe by ECCA scale evaluation.
- All the subjects were not allowed to use any systemic, topical, or light-based acne scar treatment during the course of this study.
Who cannot join
- pregnancy, mental illness.
- Intake of oral isotretinoin within 3 months
- Application of the other chemical peeling and light-based treatments within 8 weeks
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Department of Dermatology of Xijing Hospital of Air Force Medicial University
Background Adipose extracellular matrix/stromal vascular fraction gel（SVF-gel）, which contains adipose-derived stem cells, endothelial cells, smooth muscle cells, pericytes, and other cell components.
Objective To determine the efficacy and safety of SVF-gel for treating acne scars and to compare the results with CO2 fractional laser.
Methods Seventeen patients with moderate to severe acne scars were treated with SVF-gel filling and CO2 fractional laser through a 24-week, randomized split-face study. One randomly assigned half side of each patient's received one SVF-gel filling treatment and the other side by two CO2 fractional laser treatment once one months. Clinical improvement was assessed by two blinded investigators with Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) scale, VISIA and Antaro-3D detection.
Read the detailed description
This study was designed as a 24-week, prospective, randomized split-face protocol that compared clinical courses between two facial sides either receiving SVF-gel injection or CO2 fractional laser for acne scars. At the initial presentation, the evaluation of the severity of acne scar by Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) scale (Table1), VISIA and Antera 3D analysis for all enrolled patients. Then, each facial side of every patient was randomly assigned into either SVF-gel injection or CO2 fractional laser treatment side. A random allocation sequence was created using computer-based random number generators to assign the treatment modality of each side. Randomization codes were secured in a safe until all data analyses were finished. Each patient was received SVF-gel injection for just one time on one half face, CO2 fractional laser treatment for two consecutive sessions at 8-week intervals on the other half face, with a follow-up visit at 16 weeks after the final CO2 fractional laser treatment. Evaluations of each treatment sessions were performed after 1 week, 2 months of every treatment. Two dermatologists evaluating the severities of acne scars were blinded to the assignment. At patients' each evaluation visit, photographic assessments by dermatologists, VISIA and Antera 3D analysis and patients' subjective assessments were conducted.
- Conditions
- Autologous Fat Graft Harvesting, SVF-gel Preparation and Filling, CO2 Fractional Laser Treatment by Using Acupulse Device
- Being tested
- SVF-gel Filling and CO2 fractional laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVF-gel Filling and CO2 fractional laserDevice
SVF-gel preparation and filling:The autologous fat graft was harvested from the lower abdomen or inner thigh of all subjects. Then the lipoaspirate was centrifuged at 1200g for 3 minutes to obtain Coleman fat in the middle layer. The Coleman fat was then transferred between two syringes until the Coleman fat converted into a uniform emulsion, and then processed by centrifugation at 2000g for 3 min. Finally, the remaining substance under the oil layer was SVF gel. We used a 22G sharp-tip injector to inject the SVF-gel into the dermis of acne scars, and the injected materials were diffusely distributed.
CO2 fractional laser treatment: After local anesthesia, Acupulse device (LUMENIS, US) was used to perform CO2 fractional laser. The laser was operated in DeepFX mode under the parameters of 20-25 MJ energy intensity, 5% coverage. Superficial mode under the parameters of 80-120 MJ energy intensity, 40-60% coverage.
| Study group | Role | What they receive |
|---|---|---|
| CO2 fractional laser treatment | Active comparator | One side face was random to receive CO2 fractional laser. After local anesthesia, Acupulse device (LUMENIS, US) was used to perform CO2 fractional laser. The laser was operated in DeepFX mode under the parameters of 20-25 MJ energy intensity, 5% coverage, 300 Hz emission frequency and on the 10 mm spot size without overlap, Superficial mode under the parameters of 80-120 MJ energy intensity, 40-60% coverage, 300 Hz emission frequency, 10 mm spot size without overlap. Receives: Device: SVF-gel Filling and CO2 fractional laser |
| SVF-gel preparation and filling | Experimental | The other side face received SVF-gel filling. The autologous fat graft was harvested from the lower abdomen or inner thigh of all subjects. The Coleman fat was was islolated by centrifugation. Then, SVF gel further islolated by using cutting and centrifugation. 22G sharp-tip injector was used to inject the SVF-gel into the dermis of acne scars. Receives: Device: SVF-gel Filling and CO2 fractional laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECCA scale score
ECCA scale score of each face before and after the treatment of SVF-gel filling and CO2 Fractional Laser
Measured: 3 Month after the second CO2 Fractional Laser treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start20 Jan 2021
- Primary completion20 Jul 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autologous Fat Graft Harvesting, SVF-gel Preparation and FillingStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Seventeen patients with moderate to severe acne scars were treated with SVF-gel filling and CO2 fractional laser through a 24-week, randomized split-face study. One randomly assigned half side of each patient's received one SVF-gel filling treatment and the other side by two CO2 fractional laser treatment once one months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Wang, Ph.D., Study director, Xijing Hospital of Air Force University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116162
- Sponsor's protocol ID
- KY20202029-F-2
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to describe
Publications
Bhargava S, Cunha PR, Lee J, Kroumpouzos G. Acne Scarring Management: Systematic Review and Evaluation of the Evidence. Am J Clin Dermatol. 2018 Aug;19(4):459-477. doi: 10.1007/s40257-018-0358-5.
PubMed 29744784Connolly D, Vu HL, Mariwalla K, Saedi N. Acne Scarring-Pathogenesis, Evaluation, and Treatment Options. J Clin Aesthet Dermatol. 2017 Sep;10(9):12-23. Epub 2017 Sep 1.
PubMed 29344322Boen M, Jacob C. A Review and Update of Treatment Options Using the Acne Scar Classification System. Dermatol Surg. 2019 Mar;45(3):411-422. doi: 10.1097/DSS.0000000000001765.
PubMed 30856634Yao Y, Cai J, Zhang P, Liao Y, Yuan Y, Dong Z, Lu F. Adipose Stromal Vascular Fraction Gel Grafting: A New Method for Tissue Volumization and Rejuvenation. Dermatol Surg. 2018 Oct;44(10):1278-1286. doi: 10.1097/DSS.0000000000001556.
PubMed 29781904Zhao T, Li M, Wang J, Liu J, Wei J, Liu X, Gao C, Li B. Comparison of the Effects of Adipose Extracellular Matrix/Stromal Vascular Fraction Gel Injection and CO2 Fractional Laser on Atrophic Acne Scar in Asians Through a 24-Week Prospective, Randomized, Split-Face Study. J Cosmet Dermatol. 2025 Mar;24(3):e70131. doi: 10.1111/jocd.70131.
PubMed 40112029
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Dermatology of Xijing Hospital of Air Force Medicial University
- ClinicalTrials.gov ID
- NCT06116162
- Acronym / sponsor ID
- KY20202029-F-2
- Conditions
- Autologous Fat Graft Harvesting, SVF-gel Preparation and Filling, CO2 Fractional Laser Treatment by Using Acupulse Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Adipose extracellular matrix/stromal vascular fraction gel（SVF-gel）, which contains adipose-derived stem cells, endothelial cells, smooth muscle cells, pericytes, and other cell components.
Objective To determine the efficacy and safety of SVF-gel for treating acne scars and to compare the results with CO2 fractional laser.
Methods Seventeen patients with moderate to severe acne scars were treated with SVF-gel filling and CO2 fractional laser through a 24-week, randomized split-face study. One randomly assigned half side of each patient's received one SVF-gel filling treatment and the other side by two CO2 fractional laser treatment once one months. Clinical improvement was assessed by two blinded investigators with Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) scale, VISIA and Antaro-3D detection.
Detailed description
This study was designed as a 24-week, prospective, randomized split-face protocol that compared clinical courses between two facial sides either receiving SVF-gel injection or CO2 fractional laser for acne scars. At the initial presentation, the evaluation of the severity of acne scar by Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) scale (Table1), VISIA and Antera 3D analysis for all enrolled patients. Then, each facial side of every patient was randomly assigned into either SVF-gel injection or CO2 fractional laser treatment side. A random allocation sequence was created using computer-based random number generators to assign the treatment modality of each side. Randomization codes were secured in a safe until all data analyses were finished. Each patient was received SVF-gel injection for just one time on one half face, CO2 fractional laser treatment for two consecutive sessions at 8-week intervals on the other half face, with a follow-up visit at 16 weeks after the final CO2 fractional laser treatment. Evaluations of each treatment sessions were performed after 1 week, 2 months of every treatment. Two dermatologists evaluating the severities of acne scars were blinded to the assignment. At patients' each evaluation visit, photographic assessments by dermatologists, VISIA and Antera 3D analysis and patients' subjective assessments were conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Seventeen patients with moderate to severe acne scars were treated with SVF-gel filling and CO2 fractional laser through a 24-week, randomized split-face study. One randomly assigned half side of each patient's received one SVF-gel filling treatment and the other side by two CO2 fractional laser treatment once one months.
| Arm | Type | Receives |
|---|---|---|
| CO2 fractional laser treatment | Active comparator | Device: SVF-gel Filling and CO2 fractional laserOne side face was random to receive CO2 fractional laser. After local anesthesia, Acupulse device (LUMENIS, US) was used to perform CO2 fractional laser. The laser was operated in DeepFX mode under the parameters of 20-25 MJ energy intensity, 5% coverage, 300 Hz emission frequency and on the 10 mm spot size without overlap, Superficial mode under the parameters of 80-120 MJ energy intensity, 40-60% coverage, 300 Hz emission frequency, 10 mm spot size without overlap. |
| SVF-gel preparation and filling | Experimental | Device: SVF-gel Filling and CO2 fractional laserThe other side face received SVF-gel filling. The autologous fat graft was harvested from the lower abdomen or inner thigh of all subjects. The Coleman fat was was islolated by centrifugation. Then, SVF gel further islolated by using cutting and centrifugation. 22G sharp-tip injector was used to inject the SVF-gel into the dermis of acne scars. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Acne scar patients with severity of moderate to severe by ECCA scale evaluation.
- All the subjects were not allowed to use any systemic, topical, or light-based acne scar treatment during the course of this study.
Key exclusion criteria (3 listed)
- pregnancy, mental illness.
- Intake of oral isotretinoin within 3 months
- Application of the other chemical peeling and light-based treatments within 8 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SVF-gel Filling and CO2 fractional laserSVF-gel preparation and filling:The autologous fat graft was harvested from the lower abdomen or inner thigh of all subjects. Then the lipoaspirate was centrifuged at 1200g for 3 minutes to obtain Coleman fat in the middle layer. The Coleman fat was then transferred between two syringes until the Coleman fat converted into a uniform emulsion, and then processed by centrifugation at 2000g for 3 min. Finally, the remaining substance under the oil layer was SVF gel. We used a 22G sharp-tip injector to inject the SVF-gel into the dermis of acne scars, and the injected materials were diffusely distributed. CO2 fractional laser treatment: After local anesthesia, Acupulse device (LUMENIS, US) was used to perform CO2 fractional laser. The laser was operated in DeepFX mode under the parameters of 20-25 MJ energy intensity, 5% coverage. Superficial mode under the parameters of 80-120 MJ energy intensity, 40-60% coverage. | Device | CO2 fractional laser treatment, SVF-gel preparation and filling |
Primary outcome
ECCA scale score
Time frame: 3 Month after the second CO2 Fractional Laser treatment
ECCA scale score of each face before and after the treatment of SVF-gel filling and CO2 Fractional Laser
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Background: PubMed 29744784Bhargava S, Cunha PR, Lee J, Kroumpouzos G. Acne Scarring Management: Systematic Review and Evaluation of the Evidence. Am J Clin Dermatol. 2018 Aug;19(4):459-477. doi: 10.1007/s40257-018-0358-5.
- Background: PubMed 29344322Connolly D, Vu HL, Mariwalla K, Saedi N. Acne Scarring-Pathogenesis, Evaluation, and Treatment Options. J Clin Aesthet Dermatol. 2017 Sep;10(9):12-23. Epub 2017 Sep 1.
- Results publication: PubMed 30856634Boen M, Jacob C. A Review and Update of Treatment Options Using the Acne Scar Classification System. Dermatol Surg. 2019 Mar;45(3):411-422. doi: 10.1097/DSS.0000000000001765.
- Results publication: PubMed 29781904Yao Y, Cai J, Zhang P, Liao Y, Yuan Y, Dong Z, Lu F. Adipose Stromal Vascular Fraction Gel Grafting: A New Method for Tissue Volumization and Rejuvenation. Dermatol Surg. 2018 Oct;44(10):1278-1286. doi: 10.1097/DSS.0000000000001556.
- Derived from this study: PubMed 40112029Zhao T, Li M, Wang J, Liu J, Wei J, Liu X, Gao C, Li B. Comparison of the Effects of Adipose Extracellular Matrix/Stromal Vascular Fraction Gel Injection and CO2 Fractional Laser on Atrophic Acne Scar in Asians Through a 24-Week Prospective, Randomized, Split-Face Study. J Cosmet Dermatol. 2025 Mar;24(3):e70131. doi: 10.1111/jocd.70131.
- Individual participant dataSharing planned: No. No plan to describe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Wang, Ph.D. study director
Xijing Hospital of Air Force University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SVF-gel Filling and CO2 fractional laser in people with Autologous Fat Graft Harvesting, SVF-gel Preparation and Filling and CO2 Fractional Laser Treatment by Using Acupulse Device, run by Xijing Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECCA scale score (time frame: 3 Month after the second CO2 Fractional Laser treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06116162, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.