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Pilot Study of Combination Treatment With Subcision, Human Adipose Tissue-Derived Exosomes and Powdered Polydioxanone for Atrophic Acne Scars

28 ottobre 2026 aggiornato da: COSMEDICIAN AP SDN BHD

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

12

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50088
        • FFIMT Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Adults aged 18 to 55 years, of any sex, ethnicity, or nationality.
  2. Bilateral atrophic acne scars of clinically comparable severity.
  3. No acne-scar treatment during the three months before enrollment.
  4. Able to understand the study information and willing to provide written informed consent.

Exclusion Criteria:

  1. Active inflammatory acne.
  2. Active herpes labialis.
  3. Human immunodeficiency virus (HIV) infection.
  4. Hepatitis B infection.
  5. History of keloid or hypertrophic scar formation.
  6. Bleeding disorders.
  7. Pregnancy or lactation.
  8. Previous facial surgery.
  9. Current systemic isotretinoin use or use within the six months before enrollment.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: Subcision

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.
Sperimentale: 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.
Procedura: Subcision

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.

Altro: Human Adipose-Derived Stem Cell Exosomes and Powdered Polydioxanone

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Atrophic Acne Scar Severity Using the Goodman and Baron Qualitative Acne Scar Grading System
Lasso di tempo: 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.
Baseline (Week 0) and Week 16

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dermatologist-Rated Global Aesthetic Improvement Scale
Lasso di tempo: Week 16

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
Change in Participant-Rated Satisfaction With Facial Appearance
Lasso di tempo: Baseline (Week 0) and Week 16

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
Procedural Pain
Lasso di tempo: Immediately after treatment at Weeks 0, 4, 8, 12 and through week 16

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
Duration of Post-Procedural Downtime
Lasso di tempo: Following treatments at Weeks 0, 4, 8, 12 and through week 16

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
Change in Skin Colour Unevenness
Lasso di tempo: Baseline (Week 0) and Week 16

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

COSMEDICIAN AP SDN BHD

Investigatori

  • Investigatore principale: Edmond Ng Siah Chye, MD, Msc, UCSI University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2023

Completamento primario (Effettivo)

1 settembre 2024

Completamento dello studio (Effettivo)

1 gennaio 2025

Date di iscrizione allo studio

Primo inviato

28 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 ottobre 2026

Primo Inserito (Effettivo)

3 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • UCSI/IEC-2023-FMHS-0021(A)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

The team has not decided

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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