Pilot Study of Combination Treatment With Subcision, Human Adipose Tissue-Derived Exosomes and Powdered Polydioxanone for Atrophic Acne Scars
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malajsie, 50088
- FFIMT Clinic
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Active inflammatory acne.
- Active herpes labialis.
- Human immunodeficiency virus (HIV) infection.
- Hepatitis B infection.
- History of keloid or hypertrophic scar formation.
- Bleeding disorders.
- Pregnancy or lactation.
- Previous facial surgery.
- Current systemic isotretinoin use or use within the six months before enrollment.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Subcision Alone - Left Facial Side
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. |
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. |
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Experimentální: Subcision Plus hADSC-Exos/PDO - Right Facial Side
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. |
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. 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Atrophic Acne Scar Severity Using the Goodman and Baron Qualitative Acne Scar Grading System
Časové okno: Baseline (Week 0) and Week 16
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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. |
Baseline (Week 0) and Week 16
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Dermatologist-Rated Global Aesthetic Improvement Scale
Časové okno: Week 16
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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. |
Week 16
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Change in Participant-Rated Satisfaction With Facial Appearance
Časové okno: Baseline (Week 0) and Week 16
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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. |
Baseline (Week 0) and Week 16
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Procedural Pain
Časové okno: Immediately after treatment at Weeks 0, 4, 8, 12 and through week 16
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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. |
Immediately after treatment at Weeks 0, 4, 8, 12 and through week 16
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Duration of Post-Procedural Downtime
Časové okno: Following treatments at Weeks 0, 4, 8, 12 and through week 16
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Duration of post-procedural downtime in days after each treatment session, recorded using participant treatment diaries and investigator assessments. |
Following treatments at Weeks 0, 4, 8, 12 and through week 16
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Change in Skin Colour Unevenness
Časové okno: Baseline (Week 0) and Week 16
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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. |
Baseline (Week 0) and Week 16
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Edmond Ng Siah Chye, MD, Msc, UCSI University
Publikace a užitečné odkazy
Obecné publikace
- 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.
- Shin 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.
- Liu 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- UCSI/IEC-2023-FMHS-0021(A)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The team has not decided
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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