Atrophic Acne ScarsNCT07914322
Pilot Study of Combination Treatment With Subcision, Human Adipose Tissue-Derived Exosomes and Powdered Polydioxanone for Atrophic Acne Scars
A study testing Subcision and Human Adipose-Derived Stem Cell Exosomes and Powdered Polydioxanone in people with Atrophic Acne Scars, run by COSMEDICIAN AP SDN BHD at 1 site in Malaysia.
Trial summary
This pilot study compared two treatments for depressed acne scars: subcision alone and subcision followed by injections containing exosomes derived from human fat-derived stem cells and powdered polydioxanone (PDO). Subcision is a procedure that releases bands of tissue beneath the skin that pull acne scars downward. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atrophic Acne Scars
- What is being tested?
- Subcision and Human Adipose-Derived Stem Cell Exosomes and Powdered Polydioxanone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2023to 1 Jan 2025
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 55 years, of any sex, ethnicity, or nationality.
- Bilateral atrophic acne scars of clinically comparable severity.
- No acne-scar treatment during the three months before enrollment.
- Able to understand the study information and willing to provide written informed consent.
Who cannot join
- Active inflammatory acne.
- Active herpes labialis.
- Human immunodeficiency virus (HIV) infection.
- Hepatitis B infection.
- History of keloid or hypertrophic scar formation.
- Bleeding disorders.
Show all 9Show fewer
- Pregnancy or lactation.
- Previous facial surgery.
- Current systemic isotretinoin use or use within the six months before enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adipose-Derived Stem Cell Exosomes and Powdered Polydioxanone as Adjuncts to Subcision for Atrophic Acne Scars: A Prospective Split-Face Pilot Study
This pilot study compared two treatments for depressed acne scars: subcision alone and subcision followed by injections containing exosomes derived from human fat-derived stem cells and powdered polydioxanone (PDO). Subcision is a procedure that releases bands of tissue beneath the skin that pull acne scars downward.
Twelve adults with acne scars on both sides of the face participated at one clinic in Kuala Lumpur, Malaysia. Each participant received subcision alone on the left side and subcision with the additional injections on the right side. Three treatment sessions were performed four weeks apart, with a final assessment at Week 12.
The study examined whether adding the injections improved acne scar severity and overall appearance compared with subcision alone. Skin quality, treatment discomfort, recovery time, and unwanted effects were also assessed. A dermatologist who did not know which treatment each side received evaluated standardized photographs. This small study was intended to provide preliminary information to help plan larger studies.
Read the detailed description
This prospective, single-centre, non-randomised, assessor-blinded, split-face comparative pilot study evaluated the addition of human adipose-derived stem cell exosomes (hADSC-Exos) and powdered polydioxanone (PDO) to subcision for atrophic acne scars.
The split-face design allowed comparison of the treatments within the same participant. Treatment allocation was fixed: the left side received subcision alone, and the right side received the same subcision procedure followed by injection of the combined hADSC-Exos/PDO formulation. Participants were aware of treatment allocation.
Twelve participants were enrolled through convenience sampling at FFIMT Clinic, Kuala Lumpur, Malaysia. No formal efficacy sample-size calculation was performed because prior treatment-effect and variability estimates were unavailable. The pilot sample was selected to provide preliminary estimates of treatment effects, variability, and feasibility for subsequent studies.
Treatment sessions took place at Weeks 0, 4, and 8. On the combination-treatment side, 2.5 mL of the prepared hADSC-Exos/PDO suspension was injected into the subdermal plane after scar release. The final clinical assessment occurred at Week 12, four weeks after the third treatment.
Standardized facial photographs were obtained at baseline and Week 12 under consistent lighting, positioning, and camera settings. An independent dermatologist, blinded to treatment allocation and assessment time point, performed the photographic assessments. Participant assessments, treatment diaries, and investigator clinical assessments provided additional information on perceived improvement, skin quality, procedural pain, recovery, and treatment-emergent adverse effects.
The study received UCSI University Institutional Review Board approval before recruitment, and all participants provided written informed consent before study procedures.
- Conditions
- Atrophic Acne Scars
- Being tested
- Subcision, Human Adipose-Derived Stem Cell Exosomes and Powdered Polydioxanone
- Keywords
- atrophic acne scars, subcision, exosomes, polydioxanone, split-face study, skin quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SubcisionProcedure or surgery
Subdermal release of fibrotic scar adhesions using a 25-gauge, 50-mm blunt-tip cannula, with linear lancing and side-to-side fanning movements. Performed at Weeks 0, 4, and 8.
Human Adipose-Derived Stem Cell Exosomes and Powdered PolydioxanoneOther
A suspension prepared by mixing 5 mL of human adipose-derived stem cell exosomes, containing approximately 15 billion particles, with 150 mg of powdered polydioxanone. A 2.5-mL volume of the prepared suspension was injected subdermally into the right facial side after subcision at each treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Subcision Alone - Left Facial Side | Active comparator | The left facial side of each participant received subcision alone using a blunt-tip cannula to release fibrotic adhesions beneath atrophic acne scars. Three sessions were performed at Weeks 0, 4, and 8. Receives: Procedure: Subcision |
| Subcision Plus hADSC-Exos/PDO - Right Facial Side | Experimental | The right facial side of each participant received subcision followed by subdermal injection of 2.5 mL of a suspension containing human adipose-derived stem cell exosomes and powdered polydioxanone. Three sessions were performed at Weeks 0, 4, and 8. Receives: Procedure: Subcision; Other: Human Adipose-Derived Stem Cell Exosomes and Powdered Polydioxanone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Atrophic Acne Scar Severity Using the Goodman and Baron Qualitative Acne Scar Grading System
Change from baseline to Week 16 in acne scar severity, assessed separately for each facial side by an independent blinded dermatologist using standardized photographs. The Goodman and Baron Qualitative Acne Scar Grading System grades severity from 1 to 4: grade 1 = macular scarring, grade 2 = mild scarring, grade 3 = moderate scarring, and grade 4 = severe scarring. Lower grades indicate less severe scarring. Changes will be compared between the combination-treatment side and the subcision-only side.
Measured: Baseline (Week 0) and Week 16
Secondary outcomes (5)
Dermatologist-Rated Global Aesthetic Improvement Scale
Overall aesthetic improvement of each facial side, assessed by the blinded dermatologist using the Global Aesthetic Improvement Scale: 1 = exceptional improvement, 2 = very improved, 3 = improved, 4 = unaltered, and 5 = worsened. Lower scores indicate greater improvement.
Measured: Week 16
Change in Participant-Rated Satisfaction With Facial Appearance
Participant-rated satisfaction with facial appearance before and after treatment, using a four-category self-satisfaction scale: 1 = poor (0-24%), 2 = good (25-49%), 3 = very good (50-74%), and 4 = excellent (75-100%). Higher scores indicate greater satisfaction.
Measured: Baseline (Week 0) and Week 16
Procedural Pain
Participant-rated pain immediately after each treatment, measured using a Numeric Rating Scale from 0 = no pain to 10 = worst imaginable pain. Higher scores indicate greater pain.
Measured: Immediately after treatment at Weeks 0, 4, 8, 12 and through week 16
Duration of Post-Procedural Downtime
Duration of post-procedural downtime in days after each treatment session, recorded using participant treatment diaries and investigator assessments.
Measured: Following treatments at Weeks 0, 4, 8, 12 and through week 16
Change in Skin Colour Unevenness
Change from baseline to Week 16 in skin colour unevenness, assessed using the corresponding item of the Galderma Facial Skin Quality Assessment Scale. Severity is rated from 0 to 3: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Lower scores indicate more even skin colour.
Measured: Baseline (Week 0) and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Dec 2023
- Primary completion1 Sep 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrophic Acne ScarsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomised, split-face, within-participant comparison. All 12 participants received subcision alone on the left facial side and subcision followed by human adipose-derived stem cell exosomes and powdered polydioxanone injection on the right facial side. Treatments were administered at Weeks 0, 4, and 8, with final assessment at Week 12. Each participant served as their own control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- COSMEDICIAN AP SDN BHD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edmond Ng Siah Chye, MD, Msc, Principal investigator, UCSI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914322
- Sponsor's protocol ID
- UCSI/IEC-2023-FMHS-0021(A)
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The team has not decided
Publications
Majewska L, Kondraciuk A, Dorosz K, Budzynska A. Application of Standardized Rosa damascena Stem Cell-Derived Exosomes in Dermatological Wound Healing and Scar Management: A Retrospective Case-Series Study with Long-Term Outcome Assessment. Pharmaceutics. 2025 Jul 14;17(7):910. doi: 10.3390/pharmaceutics17070910.
PubMed 40733118Shin KO, Ha DH, Kim JO, Crumrine DA, Meyer JM, Wakefield JS, Lee Y, Kim B, Kim S, Kim HK, Lee J, Kwon HH, Park GH, Lee JH, Lim J, Park S, Elias PM, Park K, Yi YW, Cho BS. Exosomes from Human Adipose Tissue-Derived Mesenchymal Stem Cells Promote Epidermal Barrier Repair by Inducing de Novo Synthesis of Ceramides in Atopic Dermatitis. Cells. 2020 Mar 10;9(3):680. doi: 10.3390/cells9030680.
PubMed 32164386Liu K, Chen C, Zhang H, Chen Y, Zhou S. Adipose stem cell-derived exosomes in combination with hyaluronic acid accelerate wound healing through enhancing re-epithelialization and vascularization. Br J Dermatol. 2019 Oct;181(4):854-856. doi: 10.1111/bjd.17984. Epub 2019 Aug 12. No abstract available.
PubMed 30953591
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose-Derived Stem Cell Exosomes and Powdered Polydioxanone as Adjuncts to Subcision for Atrophic Acne Scars: A Prospective Split-Face Pilot Study
- ClinicalTrials.gov ID
- NCT07914322
- Acronym / sponsor ID
- UCSI/IEC-2023-FMHS-0021(A)
- Conditions
- Atrophic Acne Scars
- Keywords
- atrophic acne scars, subcision, exosomes, polydioxanone, split-face study, skin quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- COSMEDICIAN AP SDN BHDIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 3 Nov 2026 (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.
This pilot study compared two treatments for depressed acne scars: subcision alone and subcision followed by injections containing exosomes derived from human fat-derived stem cells and powdered polydioxanone (PDO). Subcision is a procedure that releases bands of tissue beneath the skin that pull acne scars downward.
Twelve adults with acne scars on both sides of the face participated at one clinic in Kuala Lumpur, Malaysia. Each participant received subcision alone on the left side and subcision with the additional injections on the right side. Three treatment sessions were performed four weeks apart, with a final assessment at Week 12.
The study examined whether adding the injections improved acne scar severity and overall appearance compared with subcision alone. Skin quality, treatment discomfort, recovery time, and unwanted effects were also assessed. A dermatologist who did not know which treatment each side received evaluated standardized photographs. This small study was intended to provide preliminary information to help plan larger studies.
Detailed description
This prospective, single-centre, non-randomised, assessor-blinded, split-face comparative pilot study evaluated the addition of human adipose-derived stem cell exosomes (hADSC-Exos) and powdered polydioxanone (PDO) to subcision for atrophic acne scars.
The split-face design allowed comparison of the treatments within the same participant. Treatment allocation was fixed: the left side received subcision alone, and the right side received the same subcision procedure followed by injection of the combined hADSC-Exos/PDO formulation. Participants were aware of treatment allocation.
Twelve participants were enrolled through convenience sampling at FFIMT Clinic, Kuala Lumpur, Malaysia. No formal efficacy sample-size calculation was performed because prior treatment-effect and variability estimates were unavailable. The pilot sample was selected to provide preliminary estimates of treatment effects, variability, and feasibility for subsequent studies.
Treatment sessions took place at Weeks 0, 4, and 8. On the combination-treatment side, 2.5 mL of the prepared hADSC-Exos/PDO suspension was injected into the subdermal plane after scar release. The final clinical assessment occurred at Week 12, four weeks after the third treatment.
Standardized facial photographs were obtained at baseline and Week 12 under consistent lighting, positioning, and camera settings. An independent dermatologist, blinded to treatment allocation and assessment time point, performed the photographic assessments. Participant assessments, treatment diaries, and investigator clinical assessments provided additional information on perceived improvement, skin quality, procedural pain, recovery, and treatment-emergent adverse effects.
The study received UCSI University Institutional Review Board approval before recruitment, and all participants provided written informed consent before study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-randomised, split-face, within-participant comparison. All 12 participants received subcision alone on the left facial side and subcision followed by human adipose-derived stem cell exosomes and powdered polydioxanone injection on the right facial side. Treatments were administered at Weeks 0, 4, and 8, with final assessment at Week 12. Each participant served as their own control.
| Arm | Type | Receives |
|---|---|---|
| Subcision Alone - Left Facial Side | Active comparator | Procedure: SubcisionThe left facial side of each participant received subcision alone using a blunt-tip cannula to release fibrotic adhesions beneath atrophic acne scars. Three sessions were performed at Weeks 0, 4, and 8. |
| Subcision Plus hADSC-Exos/PDO - Right Facial Side | Experimental | Procedure: Subcision, Other: Human Adipose-Derived Stem Cell Exosomes and Powdered PolydioxanoneThe right facial side of each participant received subcision followed by subdermal injection of 2.5 mL of a suspension containing human adipose-derived stem cell exosomes and powdered polydioxanone. Three sessions were performed at Weeks 0, 4, and 8. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 55 years, of any sex, ethnicity, or nationality.
- Bilateral atrophic acne scars of clinically comparable severity.
- No acne-scar treatment during the three months before enrollment.
- Able to understand the study information and willing to provide written informed consent.
Key exclusion criteria (9 listed)
- Active inflammatory acne.
- Active herpes labialis.
- Human immunodeficiency virus (HIV) infection.
- Hepatitis B infection.
- History of keloid or hypertrophic scar formation.
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 |
|---|---|---|
| SubcisionSubdermal release of fibrotic scar adhesions using a 25-gauge, 50-mm blunt-tip cannula, with linear lancing and side-to-side fanning movements. Performed at Weeks 0, 4, and 8. | Procedure or surgery | Subcision Alone - Left Facial Side, Subcision Plus hADSC-Exos/PDO - Right Facial Side |
| Human Adipose-Derived Stem Cell Exosomes and Powdered PolydioxanoneA suspension prepared by mixing 5 mL of human adipose-derived stem cell exosomes, containing approximately 15 billion particles, with 150 mg of powdered polydioxanone. A 2.5-mL volume of the prepared suspension was injected subdermally into the right facial side after subcision at each treatment session. | Other | Subcision Plus hADSC-Exos/PDO - Right Facial Side |
Primary outcome
Change in Atrophic Acne Scar Severity Using the Goodman and Baron Qualitative Acne Scar Grading System
Time frame: Baseline (Week 0) and Week 16
Change from baseline to Week 16 in acne scar severity, assessed separately for each facial side by an independent blinded dermatologist using standardized photographs. The Goodman and Baron Qualitative Acne Scar Grading System grades severity from 1 to 4: grade 1 = macular scarring, grade 2 = mild scarring, grade 3 = moderate scarring, and grade 4 = severe scarring. Lower grades indicate less severe scarring. Changes will be compared between the combination-treatment side and the subcision-only side.
5 secondary outcomes
Dermatologist-Rated Global Aesthetic Improvement Scale
Time frame: Week 16
Change in Participant-Rated Satisfaction With Facial Appearance
Time frame: Baseline (Week 0) and Week 16
Procedural Pain
Time frame: Immediately after treatment at Weeks 0, 4, 8, 12 and through week 16
Duration of Post-Procedural Downtime
Time frame: Following treatments at Weeks 0, 4, 8, 12 and through week 16
Change in Skin Colour Unevenness
Time frame: Baseline (Week 0) and Week 16
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 2026.
- Background: PubMed 40733118Majewska L, Kondraciuk A, Dorosz K, Budzynska A. Application of Standardized Rosa damascena Stem Cell-Derived Exosomes in Dermatological Wound Healing and Scar Management: A Retrospective Case-Series Study with Long-Term Outcome Assessment. Pharmaceutics. 2025 Jul 14;17(7):910. doi: 10.3390/pharmaceutics17070910.
- Background: PubMed 32164386Shin KO, Ha DH, Kim JO, Crumrine DA, Meyer JM, Wakefield JS, Lee Y, Kim B, Kim S, Kim HK, Lee J, Kwon HH, Park GH, Lee JH, Lim J, Park S, Elias PM, Park K, Yi YW, Cho BS. Exosomes from Human Adipose Tissue-Derived Mesenchymal Stem Cells Promote Epidermal Barrier Repair by Inducing de Novo Synthesis of Ceramides in Atopic Dermatitis. Cells. 2020 Mar 10;9(3):680. doi: 10.3390/cells9030680.
- Background: PubMed 30953591Liu K, Chen C, Zhang H, Chen Y, Zhou S. Adipose stem cell-derived exosomes in combination with hyaluronic acid accelerate wound healing through enhancing re-epithelialization and vascularization. Br J Dermatol. 2019 Oct;181(4):854-856. doi: 10.1111/bjd.17984. Epub 2019 Aug 12. No abstract available.
- Individual participant dataSharing planned: Undecided. The team has not decided
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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.
Edmond Ng Siah Chye, MD, Msc principal investigator
UCSI University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcision and Human Adipose-Derived Stem Cell Exosomes and Powdered Polydioxanone in people with Atrophic Acne Scars, run by COSMEDICIAN AP SDN BHD at 1 site in Malaysia.
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 4 inclusion and 9 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 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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?
Change in Atrophic Acne Scar Severity Using the Goodman and Baron Qualitative Acne Scar Grading System (time frame: Baseline (Week 0) and Week 16). 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 NCT07914322, which also lists 3 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 2026.