NCT07094958

Brief Summary

This study aims to evaluate the efficacy and safety of intradermal injection of autologous stromal vascular fraction (SVF) in the treatment of atrophic acne scars. SVF is a heterogeneous cell population derived from adipose tissue, containing various regenerative and immunomodulatory cells, including mesenchymal stem cells, endothelial progenitor cells, and pericytes. In this prospective, randomized, split-face clinical trial, participants with atrophic acne scars will receive SVF injections on one side of the face and normal saline (NS) injections on the contralateral side as a control. Clinical efficacy will be assessed through blinded scar counts, digital imaging, and histological evaluations including epidermal and dermal regenerative markers. The study is designed to investigate whether SVF provides superior clinical improvement compared to placebo.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jul 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2025Jul 2026

Study Start

First participant enrolled

July 1, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 29, 2025

Last Update Submit

July 29, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in total number of atrophic acne scars from baseline to Week 5

    Baseline and 5 weeks after treatment

  • Change in total number of atrophic acne scars from baseline to Week 10

    Baseline and 10 weeks after treatment

Study Arms (2)

SVF-treated side

EXPERIMENTAL

Intradermal injection of autologous stromal vascular fraction (SVF) on one side of the face.

Biological: stromal vascular fraction (SVF)

Saline-treated side

PLACEBO COMPARATOR

Intradermal injection of normal saline (NS) on the contralateral side of the face.

Other: Normal Saline (NS)

Interventions

Autologous stromal vascular fraction (SVF) isolated from adipose tissue was injected intradermally into one side of the face to evaluate its efficacy in treating atrophic acne scars. SVF was freshly prepared on the same day of injection using enzymatic digestion and centrifugation.

SVF-treated side

Normal saline (NS) was injected intradermally into the contralateral side of the face and served as a placebo comparator to SVF in this split-face study on atrophic acne scars.

Saline-treated side

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 19 and 45 years
  • Presence of bilateral atrophic acne scars (boxcar, rolling, or icepick types) on the face
  • Willingness to undergo fat harvesting procedure
  • Ability to comply with study visits and follow-up
  • Written informed consent obtained

You may not qualify if:

  • Active acne lesions on the treatment area
  • History of keloid or hypertrophic scarring
  • Prior treatment for acne scars (e.g., laser, filler, microneedling) within the past 6 months
  • History of systemic immunosuppressive therapy within the past 3 months
  • Pregnant or breastfeeding women
  • Any systemic disease that may interfere with wound healing or safety assessment (e.g., uncontrolled diabetes, collagen vascular disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Mbiine R, Wayengera M, Kiwanuka N, Munabi I, Muwonge H, Nakanwagi C, Joloba M, Galukande M. Autologous adipose-derived stromal vascular fraction (SVF) in scar treatment among patients with keloids and hypertrophic scars: a systematic review and meta-analysis of current practices and outcomes. Am J Stem Cells. 2023 Dec 15;12(5):98-111. eCollection 2023.

    PMID: 38213639BACKGROUND
  • Bora P, Majumdar AS. Adipose tissue-derived stromal vascular fraction in regenerative medicine: a brief review on biology and translation. Stem Cell Res Ther. 2017 Jun 15;8(1):145. doi: 10.1186/s13287-017-0598-y.

    PMID: 28619097BACKGROUND
  • Connolly 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.

    PMID: 29344322BACKGROUND
  • Dreno B, Layton A, Bettoli V et al. Evaluation of the prevalence, risk factors, clinical characteristics, and burden of acne scars among active acne patients in brazil, france, and the USA. J Am Acad Dermatol 2017; 76:ab132.

    BACKGROUND
  • Kwon HH, Yoon HS, Suh DH, Yoon JY, Park SK, Lee ES, Lee JH, Kim NI, Kye YC, Ro YS, Lee SJ, Kim MN, Sung KJ, Lee ES, Kim KJ; Korean Society for Acne Research. A nationwide study of acne treatment patterns in Korea: analysis of patient preconceived notions and dermatologist suggestion for treatment. Acta Derm Venereol. 2012 May;92(3):236-40. doi: 10.2340/00015555-1331.

    PMID: 22367348BACKGROUND
  • Eichenfield DZ, Sprague J, Eichenfield LF. Management of Acne Vulgaris: A Review. JAMA. 2021 Nov 23;326(20):2055-2067. doi: 10.1001/jama.2021.17633.

    PMID: 34812859BACKGROUND
  • Suh JH, Kim JY, Yoon JY, Lee JH, Kim DH, Jin U, Suh DH. Comparison of Efficacy of Intradermal Stromal Vascular Fraction Injection Versus Saline Injection in the Treatment of Atrophic Acne Scar: A 10-Week, Prospective, Randomized, Split-Face, Single-Blind Controlled Trial. Dermatol Ther (Heidelb). 2025 Dec 18. doi: 10.1007/s13555-025-01617-6. Online ahead of print.

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2025

First Posted

July 31, 2025

Study Start

July 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share