NCT06295471

A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser

A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a Difference Frequency Generation (DFG) Laser and Carbon Dioxide (CO2) Laser

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime.

Detailed description

The primary goal of this study is to compare the pain score and wound healing time in healthy subjects undergoing low fluence fractional ablation using the DFG and CO2 lasers. The secondary objective involves assessing the impact of each laser on dermal vasculature using an Optical Coherence Tomography (OCT) imaging system. Participants will be treated with the DFG and CO2 laser to the upper thighs. Photography, pain scores, and OCT imaging will be recorded over the course of the study visits. The investigators plan to enroll 23 healthy subjects to complete the study. Subjects must be equal to greater than 18 years old and may be any gender or Fitzpatrick skin type.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	DFG Laser	Laser treatment to the upper thigh
DEVICE	CO2 Laser	Laser treatment to the upper thigh
DEVICE	Optical coherence tomography (OCT)	Angiographic OCT imaging at areas of interest

Timeline

• Start date: 2024-10-16
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-03-06
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study