Atrophic Acne ScarPhase 4NCT07868445
Fractional CO₂ Laser Combined With Topical Plant-Derived Exosomes Versus Non-Cross-Linked Hyaluronic Acid for Atrophic Acne Scars
A Phase 4 study testing Fractional co2 laser, Exosomes and Hyaluronic Acid skin booster in people with Atrophic Acne Scar, run by October 6 University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic Acne Scar
- What is being tested?
- Fractional co2 laser, Exosomes and Hyaluronic Acid skin booster
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adult patients with clinical diagnosis of post - acne atrophic scars.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Split Face Comparative Study Between Fractional Carbon Dioxide Laser And Exosomes Versus Fractional Carbon Dioxide Laser And Skin Booster In The Treatment Of Post-Acne Scars
- 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
- Being tested
- Fractional co2 laser, Exosomes, Hyaluronic Acid skin booster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional co2 laserDevice
Transepidermal drug delivery through fractional co2 laser
ExosomesBiological
Topical application of exosomes immediately following fractional carbon dioxide (CO2) laser therapy.
Hyaluronic Acid skin boosterDrug
Hyaluronic acid based skin booster applied after fractional co2 laser immediately
| Study group | Role | What they receive |
|---|---|---|
| Exosomes after fractional co2 laser therapy | Active comparator | Applied topical exosomes on half of the face after fractional co2 laser Receives: 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 Receives: Device: Fractional co2 laser; Drug: Hyaluronic Acid skin booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months post-treatment
Secondary outcomes (4)
Percentage of Participants Experiencing Clinical Efficacy
Efficacy measured by investigator-rated aesthetic improvement using a standard clinical photograph evaluation.
Measured: 3 months post-treatment
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.
Measured: From day of treatment through 3 months post-treatment
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.
Measured: 3 months post-treatment
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.
Measured: 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Jun 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Acne ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanar Mohamed Bedair, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868445
- Sponsor's protocol ID
- O6U-ERC-0070
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split Face Comparative Study Between Fractional Carbon Dioxide Laser And Exosomes Versus Fractional Carbon Dioxide Laser And Skin Booster In The Treatment Of Post-Acne Scars
- ClinicalTrials.gov ID
- NCT07868445
- Acronym / sponsor ID
- O6U-ERC-0070
- Conditions
- Atrophic Acne Scar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exosomes after fractional co2 laser therapy | Active comparator | Device: Fractional co2 laser, Biological: ExosomesApplied topical exosomes on half of the face after fractional co2 laser |
| Hyaluronic acid skin booster after fractional co2 laser | Active comparator | Device: Fractional co2 laser, Drug: Hyaluronic Acid skin boosterHyaluronic acid applied topically after treating the opposite have of the face with fractional co2 laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult patients with clinical diagnosis of post - acne atrophic scars.
Key exclusion criteria (3 listed)
- • Skin lesions other than acne scars.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional co2 laserTransepidermal drug delivery through fractional co2 laser | Device | Exosomes after fractional co2 laser therapy, Hyaluronic acid skin booster after fractional co2 laser |
| ExosomesTopical application of exosomes immediately following fractional carbon dioxide (CO2) laser therapy. | Biological | Exosomes after fractional co2 laser therapy |
| Hyaluronic Acid skin boosterHyaluronic acid based skin booster applied after fractional co2 laser immediately | Drug | Hyaluronic acid skin booster after fractional co2 laser |
Primary outcome
Change in Post-Acne Atrophic Scar Severity Score
Time frame: Baseline and 3 months post-treatment
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.
4 secondary outcomes
Percentage of Participants Experiencing Clinical Efficacy
Time frame: 3 months post-treatment
Number of Participants with Treatment-Related Adverse Events
Time frame: From day of treatment through 3 months post-treatment
Correlation Between Participant Age and Clinical Response Rate
Time frame: 3 months post-treatment
Correlation Between Acne Scar Duration and Treatment Efficacy
Time frame: 3 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fractional co2 laser, Exosomes and Hyaluronic Acid skin booster in people with Atrophic Acne Scar, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-Acne Atrophic Scar Severity Score (time frame: Baseline and 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.