Nanofat Injection and Fractional CO2 Laser for Post-Traumatic Atrophic Scars

NCT07679217 | Enrolling By Invitation DMC

• 3 other identifiers: TANTA-33465-11-19TU-DERM-PTAS-2020-0133465/11/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Post-traumatic atrophic scars are characterized by skin depressions caused by loss of collagen and can lead to cosmetic and psychological concerns. Several treatment options have been proposed, including fractional carbon dioxide (CO2) laser resurfacing and autologous nanofat grafting, both of which may improve scar appearance through skin remodeling and regeneration. This prospective comparative study evaluates the safety and efficacy of fractional CO2 laser alone, autologous nanofat injection alone, and combination therapy in patients with post-traumatic atrophic scars. Sixty participants were assigned to one of three treatment groups and were assessed using the Vancouver Scar Scale, physician global assessment, patient satisfaction, dermoscopic examination, and histopathological evaluation. The study aims to determine whether combining fractional CO2 laser and nanofat injection provides superior clinical and regenerative outcomes compared with either treatment alone while maintaining an acceptable safety profile.

Conditions

Post-Traumatic Atrophic Scar; Atrophic Scar; Scar

Keywords

Atrophic scar; Post-traumatic atrophic scar; Fractional CO2 laser; Adipose-derived stem cells; Nanofat grafting

Outcome Measures

Primary Outcomes (1)

• Change in Vancouver Scar Scale Score

  The change in scar severity assessed using the Vancouver Scar Scale (VSS), including vascularity, pigmentation, and pliability, from baseline to the post-treatment assessment.

  Baseline and 3 months after completion of treatment

Secondary Outcomes (1)

• Physician Global Assessment of Clinical Improvement

  3 months after completion of treatment

Study Arms (3)

Fractional CO2 Laser

ACTIVE COMPARATOR

Participants will receive three sessions of fractional carbon dioxide laser treatment at one-month intervals.

Device: Fractional CO2 Laser

Autologous Nanofat Injection

ACTIVE COMPARATOR

Participants will receive one session of autologous nanofat injection for treatment of post-traumatic atrophic scars.

Biological: Autologous Nanofat Injection

Fractional CO2 Laser + Autologous Nanofat Injection

ACTIVE COMPARATOR

Participants will receive three sessions of fractional carbon dioxide laser at one-month intervals followed by one session of autologous nanofat injection.

Biological: Autologous Nanofat Injection; Device: Fractional CO2 Laser

Interventions

Autologous Nanofat Injection BIOLOGICAL

A single session of intradermal injection of autologous nanofat prepared from centrifuged and mechanically emulsified adipose tissue for treatment of post-traumatic atrophic scars.

Also known as: Autologous Nanofat

Autologous Nanofat Injection; Fractional CO2 Laser + Autologous Nanofat Injection

Fractional CO2 Laser DEVICE

Fractional ablative carbon dioxide laser (10,600 nm) administered in three sessions at one-month intervals for treatment of post-traumatic atrophic scars.

Also known as: Fractional Carbon Dioxide Laser

Fractional CO2 Laser; Fractional CO2 Laser + Autologous Nanofat Injection

Eligibility Criteria

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

You may qualify if:

• Male or female participants aged 12 years or older.
• Presence of post-traumatic atrophic scar(s) of at least 6 months' duration.
• No scar treatment received during the previous 6 months.
• Willingness and ability to provide written informed consent (or assent with -parental/guardian consent for minors, according to local regulations).
• Willingness to comply with study procedures and follow-up assessments.

You may not qualify if:

• Hemoglobin \<10 g/dL.
• Active infection or viral skin disease.
• Coagulopathy or hemophilia.
• Current anticoagulant therapy.
• Diabetes mellitus.
• History of keloid formation.
• History of malignancy or prior radiation therapy.
• Immunosuppression.
• Long-term systemic corticosteroid therapy.
• Photosensitivity disorders.
• Pregnancy or breastfeeding.
• Renal or hepatic disease.
• Systemic diseases affecting wound healing.
• Thin patients with insufficient adipose tissue for adipose tissue harvesting.
• Previous scar treatment within the preceding 6 months.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants with post-traumatic atrophic scars were prospectively assigned to one of three parallel treatment groups: fractional CO2 laser monotherapy, autologous nanofat injection monotherapy, or combination therapy consisting of fractional CO2 laser followed by nanofat injection. Clinical, dermoscopic, and histopathological outcomes were compared among the three groups.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: June 28, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)