Comparative Study for Facial Scar Remodeling Using Fractional Carbon Dioxide Laser Combined With PDRN Versus Fractional CO₂ Laser

NCT07472192 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 011
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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) combined with CO₂ laser therapy.

Conditions

Facial Scarring

Outcome Measures

Primary Outcomes (1)

• 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)

  4 months

Study Arms (2)

Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN)

ACTIVE COMPARATOR

includes patients who will be enrolled for PDRN injection into the surgical scar

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

Device: Fractional CO2 laser assisted PDT

Interventions

Polydeoxyribonucleotide DRUG

intralesional PDRN injections

Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN)

Fractional CO2 laser assisted PDT DEVICE

Fractional carbon dioxide (CO₂) laser therapy for facial scars

Also known as: co2 laser

Fractional CO₂ laser therapy with placebo saline injection; Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

Misr University for Science and Technology

Giza, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 29574803 BACKGROUND

MeSH Terms

Interventions

Polydeoxyribonucleotides; Lasers, Gas

Intervention Hierarchy (Ancestors)

Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Omnia Tarek Hosni

CONTACT

01117196173; 200048686@must.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator in Oral & Maxillofacial Surgery Department, MUST

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: March 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

EG (1)