Facial ScarringPhase 2PDRN CO2 LASERNCT07472192
Comparative Study for Facial Scar Remodeling Using Fractional Carbon Dioxide Laser Combined With PDRN Versus Fractional CO₂ Laser
A Phase 2 study testing Polydeoxyribonucleotide and Fractional CO2 laser assisted PDT in people with Facial Scarring, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
Facial scars are frequently deemed unpleasant and can profoundly impact a patient's psychological health. This study compares the effectiveness, safety, and capacity to speed up scar healing in the maxillofacial region between fractional carbon dioxide (CO₂) laser therapy alone and polydeoxyribonucleotide (PDRN)… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Facial Scarring
- What is being tested?
- Polydeoxyribonucleotide and Fractional CO2 laser assisted PDT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age Limitations: Participants must be between 18 and 50 years of age.
- Recently cut wounds or surgical scars from about (1-6 months).
- Consent to Participate: Willingness to provide informed consent and engage in all aspects of the study.
Who cannot join
- Pregnancy or breastfeeding at the time of study.
- Known allergy to PDRN.
- Medication use that could affect wound healing or inflammation, such as:
- Isotretinoin.
- Anticancer drugs.
- High-dose corticosteroids.
- Anticoagulants.
- Uncontrolled medical diseases (e.g., unstable diabetes, cardiac conditions).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Misr University for Science and Technology
Giza
Abeer Mohamed Kamal, Phd of OMFS, 01005168009 ext. 002, abeer.kamal@must.edu.eg
Omnia Tarek Hosni, Bachelor Degree
About this study
Official title: Comparative Study for Facial Scar Remodeling Using Fractional Carbon Dioxide Laser Combined With Polydeoxyribonucleotide (PDRN) Versus Fractional CO₂ Laser: A Randomized Controlled Clinical Study
Facial scars are frequently deemed unpleasant and can profoundly impact a patient's psychological health. This study compares the effectiveness, safety, and capacity to speed up scar healing in the maxillofacial region between fractional carbon dioxide (CO₂) laser therapy alone and polydeoxyribonucleotide (PDRN) combined with CO₂ laser therapy.
- Conditions
- Facial Scarring
- Being tested
- Polydeoxyribonucleotide, Fractional CO2 laser assisted PDT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolydeoxyribonucleotideDrug
intralesional PDRN injections
Fractional CO2 laser assisted PDTDevice
Also called co2 laser
Fractional carbon dioxide (CO₂) laser therapy for facial scars
| Study group | Role | What they receive |
|---|---|---|
| Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN) | Active comparator | includes patients who will be enrolled for PDRN injection into the surgical scar Receives: Drug: Polydeoxyribonucleotide; Device: Fractional CO2 laser assisted PDT |
| Fractional CO₂ laser therapy with placebo saline injection | Placebo comparator | includes patients who will be enrolled for placebo saline injection into the surgical scar Receives: Device: Fractional CO2 laser assisted PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Scar Scale
The study used the standard Vancouver Scar Scale, which evaluates four characteristics of scars:
Total Score Range: 0 (normal skin) to 13 (severe hypertrophic scar)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial ScarringStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Tarek Hosni, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472192
- Sponsor's protocol ID
- 011
- Acronym
- PDRN CO2 LASER
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kim JH, Jeong JJ, Lee YI, Lee WJ, Lee C, Chung WY, Nam KH, Lee JH. Preventive effect of polynucleotide on post-thyroidectomy scars: A randomized, double-blinded, controlled trial. Lasers Surg Med. 2018 Mar 25. doi: 10.1002/lsm.22812. Online ahead of print.
PubMed 29574803
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study for Facial Scar Remodeling Using Fractional Carbon Dioxide Laser Combined With Polydeoxyribonucleotide (PDRN) Versus Fractional CO₂ Laser: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07472192
- Acronym / sponsor ID
- PDRN CO2 LASER / 011
- Conditions
- Facial Scarring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 16 Mar 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.
Facial scars are frequently deemed unpleasant and can profoundly impact a patient's psychological health. This study compares the effectiveness, safety, and capacity to speed up scar healing in the maxillofacial region between fractional carbon dioxide (CO₂) laser therapy alone and polydeoxyribonucleotide (PDRN) combined with CO₂ laser therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN) | Active comparator | Drug: Polydeoxyribonucleotide, Device: Fractional CO2 laser assisted PDTincludes patients who will be enrolled for PDRN injection into the surgical scar |
| Fractional CO₂ laser therapy with placebo saline injection | Placebo comparator | Device: Fractional CO2 laser assisted PDTincludes patients who will be enrolled for placebo saline injection into the surgical scar |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age Limitations: Participants must be between 18 and 50 years of age.
- Recently cut wounds or surgical scars from about (1-6 months).
- Consent to Participate: Willingness to provide informed consent and engage in all aspects of the study.
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding at the time of study.
- Known allergy to PDRN.
- Medication use that could affect wound healing or inflammation, such as:
- Uncontrolled medical diseases (e.g., unstable diabetes, cardiac conditions).
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 |
|---|---|---|
| Polydeoxyribonucleotideintralesional PDRN injections | Drug | Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN) |
| Fractional CO2 laser assisted PDTAlso: co2 laserFractional carbon dioxide (CO₂) laser therapy for facial scars | Device | Fractional CO₂ laser therapy with placebo saline injection, Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN) |
Primary outcome
Vancouver Scar Scale
Time frame: 4 months
The study used the standard Vancouver Scar Scale, which evaluates four characteristics of scars: Total Score Range: 0 (normal skin) to 13 (severe hypertrophic scar)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 29574803Kim JH, Jeong JJ, Lee YI, Lee WJ, Lee C, Chung WY, Nam KH, Lee JH. Preventive effect of polynucleotide on post-thyroidectomy scars: A randomized, double-blinded, controlled trial. Lasers Surg Med. 2018 Mar 25. doi: 10.1002/lsm.22812. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Facial Scarring
Not yet recruiting
Tools for Return of Facial Function
Facial Scarring, Facial Trauma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polydeoxyribonucleotide and Fractional CO2 laser assisted PDT in people with Facial Scarring, run by Misr University for Science and Technology 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 16 Mar 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omnia Tarek Hosni (01117196173 ext. 002, 200048686@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07472192, which also lists 1 linked publication.
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 16 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.