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

28 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

12

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Malaisie
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaisie, 50088
        • FFIMT Clinic

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 55 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Procédure: 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.
Expérimental: 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.
Procédure: 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.

Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Atrophic Acne Scar Severity Using the Goodman and Baron Qualitative Acne Scar Grading System
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Dermatologist-Rated Global Aesthetic Improvement Scale
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

COSMEDICIAN AP SDN BHD

Les enquêteurs

  • Chercheur principal: Edmond Ng Siah Chye, MD, Msc, UCSI University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 décembre 2023

Achèvement primaire (Réel)

1 septembre 2024

Achèvement de l'étude (Réel)

1 janvier 2025

Dates d'inscription aux études

Première soumission

28 octobre 2026

Première soumission répondant aux critères de contrôle qualité

28 octobre 2026

Première publication (Réel)

3 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • UCSI/IEC-2023-FMHS-0021(A)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

The team has not decided

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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