Efficacy of Human UC-MSC-derived Exosomes and BM-MSC-derived Exosomes for Atrophic Acne Scar

NCT07510295 | Completed

• 1 other identifier: 241037-ĐHYD
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if exosomes from human umbilical cord and bone marrow can improve atrophic acne scars when used after fractional CO₂ laser treatment in adults. The main questions it aims to answer are:

• Do exosomes improve acne scars more than standard treatment alone?
• Are exosomes safe when used after laser treatment? Researchers will compare one side of the face treated with exosomes to the other side treated with a control solution (hyaluronic acid) to see if exosomes improve scar appearance and skin texture. Participants will:
• Receive two sessions of fractional CO₂ laser treatment, 4 weeks apart
• Have exosomes applied to one side of the face and a control solution applied to the other side after each treatment
• Continue applying the assigned solution at home for 2 days after each session
• Attend follow-up visits to assess scar improvement, skin texture, healing time, and side effects Researchers will measure changes in acne scars using clinical scoring systems, skin imaging, and patient satisfaction. Safety will also be monitored by recording any side effects such as redness, swelling, or acne flare. This study may help determine whether exosomes can improve the results of laser treatment for acne scars without increasing side effects

Conditions

Atrophic Acne Scars

Keywords

Atrophic acne scars; UC-MSC exosomes; BM-MSC exosomes; Fractional CO2 laser

Outcome Measures

Primary Outcomes (1)

• Percentage improvement in ECCA score

  The primary outcome is the percentage change in the Echelle d'Évaluation Clinique des Cicatrices d'Acné (ECCA) score from baseline to 4 weeks after the second fractional CO₂ laser session. ECCA scores are assessed using standardized clinical photographs by blinded dermatologists.

  Baseline to 8 weeks

Secondary Outcomes (3)

• Change in skin texture measured by VISIA imaging system

  Baseline to 8 weeks

• Investigator's Global Assessment (IGA) of acne scar improvement

  Baseline to 8 weeks

• Incidence of treatment-related adverse events

  Up to 8 weeks

Study Arms (2)

Exosome-treated side

EXPERIMENTAL

One side of the face receives topical exosome solution after fractional CO₂ laser treatment

Biological: Exosomes derived from human umbilical cord and bone marrow mesenchymal stem cells

Control (HA)-treated side

ACTIVE COMPARATOR

The contralateral side of the face receives hyaluronic acid solution after fractional CO₂ laser treatment.

Other: Hyaluronic Acid (HA)

Interventions

Hyaluronic Acid (HA) OTHER

Topical application of hyaluronic acid solution used as a control following ablative fractional CO₂ laser treatment. The solution is applied immediately after each laser session and continued twice daily for 2 days.

Control (HA)-treated side

Exosomes derived from human umbilical cord and bone marrow mesenchymal stem cells BIOLOGICAL

\- Topical application of exosomes derived from human umbilical cord and bone marrow mesenchymal stem cells applied immediately after fractional CO₂ laser treatment and continued for 2 days.

Exosome-treated side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years
• Presence of bilateral atrophic acne scars on the face
• Eligible for ablative fractional CO₂ laser treatment

You may not qualify if:

• \- Pregnancy or breastfeeding
• History of keloid or hypertrophic scarring
• Active acne inflammation or facial infection
• Use of oral isotretinoin within the past 6 months
• Recent facial procedures within the past 6 months, including ablative laser, radiofrequency microneedling, dermabrasion, or medium-to-deep chemical peel
• Use of systemic corticosteroids or non-steroidal anti-inflammatory drugs affecting wound healing

Sponsors & Collaborators

• Ngô Anh Tuấn: lead

Study Sites (1)

University Medical Center Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. Participants, treating physicians (care providers), and outcome assessors are blinded to treatment allocation. The exosome solution and control solution are prepared in identical containers with identical appearance and texture and are labeled only as "Right" or "Left" according to a computer-generated randomization sequence. This ensures that neither participants nor investigators can distinguish between treatments. Outcome assessments are performed by independent blinded evaluators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: This is a randomized, double-blind, split-face, controlled clinical trial. Each participant receives both interventions: one side of the face is treated with exosome solution, while the contralateral side receives a control solution. Allocation of treatment side is randomized. Outcome assessors are blinded to treatment assignment. This within-subject design allows direct comparison between treatments while minimizing inter-individual variability.

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 3, 2026
• Study Start: January 17, 2025
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)