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CompletedNCT07868445Updated Oct 9, 2026

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

A Phase 4 interventional study of Fractional co2 laser and Exosomes in Atrophic Acne Scar, sponsored by October 6 University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by October 6 University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jun 2025, registered Sep 2026).
Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Atrophic Acne Scar
03

In context

Lead sponsor

October 6 University is the lead sponsor of 142 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

    • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Exosomes after fractional co2 laser therapy

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

    Device: Fractional co2 laser · Biological: Exosomes

  • Active comparator
    Hyaluronic acid skin booster after fractional co2 laser

    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

  • DeviceFractional co2 laser

    Transepidermal drug delivery through fractional co2 laser

  • BiologicalExosomes

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

  • DrugHyaluronic Acid skin booster

    Hyaluronic acid based skin booster applied after fractional co2 laser immediately

06

What researchers measure

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.

    Time frame: Baseline and 3 months post-treatment

Secondary outcomes

  1. Percentage of Participants Experiencing Clinical Efficacy

    Efficacy measured by investigator-rated aesthetic improvement using a standard clinical photograph evaluation.

    Time frame: 3 months post-treatment

  2. Number of Participants with Treatment-Related Adverse Events

    Evaluation of safety and tolerability based on the incidence, severity, and duration of reported adverse skin reactions (such as prolonged erythema, edema, hyperpigmentation, or scarring) following the application of exosomes versus skin boosters.

    Time frame: From day of treatment through 3 months post-treatment

  3. Correlation Between Participant Age and Clinical Response Rate

    Statistical correlation evaluating if the patient's age (measured in years) influences the degree of scar improvement achieved by either topical intervention.

    Time frame: 3 months post-treatment

  4. Correlation Between Acne Scar Duration and Treatment Efficacy

    Statistical evaluation comparing the duration of active post-acne scarring (measured in years since onset) against the overall improvement score.

    Time frame: 3 months post-treatment

07

Study locations

1 site
  • October 6 University
    Giza, Egypt
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 1, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2025 to primary completion in Sep 2025, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2026
First posted
Oct 9, 2026
StartActual
Jun 1, 2025
Primary completionActual
Sep 1, 2025
CompletionActual
Sep 1, 2025
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07868445
Responsible party
Hanar Mohamed Bedair (Dermatology and venerology specialist, October 6 University) — Principal investigator
First posted
Oct 9, 2026
Start date
Jun 1, 2025
Primary completion
Sep 1, 2025
Completion
Sep 1, 2025
Last update
Oct 9, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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