Fractional CO₂ Laser Combined With Topical Plant-Derived Exosomes Versus Non-Cross-Linked Hyaluronic Acid for Atrophic Acne Scars

NCT07868445 | Completed Phase 4 DMC

• 1 other identifier: O6U-ERC-0070
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• Fractional CO₂ laser combined with topical exosomes and non-cross-linked hyaluronic acid both improve atrophic acne scars, but direct comparative evidence between these adjunctive therapies has been limited.
• Adding topical exosomes via laser-assisted drug delivery may enhance scar remodeling and skin elasticity compared with HA, whereas HA provides superior hydration, supporting individualized treatment selection based on therapeutic goals. These findings are preliminary and require confirmation in larger studies.

Conditions

Atrophic Acne Scar

Outcome Measures

Primary Outcomes (1)

• Change in Post-Acne Atrophic Scar Severity Score

  Quantitative assessment of post-acne atrophic scars (including shape, depth, and number) evaluated on a split-face model using the Goodman and Baron Scale. Scores range from 1 (mild) to 4 (severe), where lower scores indicate clinical improvement.

  Baseline and 3 months post-treatment

Secondary Outcomes (4)

• Percentage of Participants Experiencing Clinical Efficacy

  3 months post-treatment

• Number of Participants with Treatment-Related Adverse Events

  From day of treatment through 3 months post-treatment

• Correlation Between Participant Age and Clinical Response Rate

  3 months post-treatment

• Correlation Between Acne Scar Duration and Treatment Efficacy

  3 months post-treatment

Study Arms (2)

Exosomes after fractional co2 laser therapy

ACTIVE COMPARATOR

Applied topical exosomes on half of the face after fractional co2 laser

Device: Fractional co2 laser; Biological: Exosomes

Hyaluronic acid skin booster after fractional co2 laser

ACTIVE COMPARATOR

Hyaluronic acid applied topically after treating the opposite have of the face with fractional co2 laser

Device: Fractional co2 laser; Drug: Hyaluronic Acid skin booster

Interventions

Fractional co2 laser DEVICE

Transepidermal drug delivery through fractional co2 laser

Exosomes after fractional co2 laser therapy; Hyaluronic acid skin booster after fractional co2 laser

Exosomes BIOLOGICAL

Topical application of exosomes immediately following fractional carbon dioxide (CO2) laser therapy.

Exosomes after fractional co2 laser therapy

Hyaluronic Acid skin booster DRUG

Hyaluronic acid based skin booster applied after fractional co2 laser immediately

Hyaluronic acid skin booster after fractional co2 laser

Eligibility Criteria

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

You may qualify if:

• Healthy adult patients with clinical diagnosis of post - acne atrophic scars.

You may not qualify if:

• Skin lesions other than acne scars.
• Using other topical or systemic treatment for one month prior to the enrollment into this study.
• Concurrent use of other topical treatments for post-acne atrophic scars.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University

Giza, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology and venerology specialist

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 9, 2026
• Study Start: June 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 9, 2026

Record last verified: 2026-09

Locations

EG (1)