Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295471
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-02-21
Brief Title:
A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None