NCT04581330

The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety and efficacy of fractional CO2 laser treatment for Poikiloderma of Civatte (POC).POC is a chronic vascular and pigmentary disorder typically involving the lateral and inferior neck region, as well as the chest area. Clinically, poikiloderma appears as a combination of telangiectasia, irregular pigmentation, and atrophic changes.Little data exist regarding the use of fractional CO2 laser for management of POC. This study hopes to fulfill this purpose. The primary outcome will be a blinded assessment by dermatologists in the improvement in POC using the Physician's Global Aesthetic Improvement Scale following therapy. The secondary outcomes include subject satisfaction post-treatment and assessment of all procedure-related adverse events.

Conditions

• Poikiloderma of Civatte

Interventions

Type	Name	Description
DEVICE	DEKA SmartXide C02 laser	One pass with a 1-mm spot density and a 60 micron depth will be performed followed by a 1-mm spot density and a 200 micron depth will be used

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-12-15
• Completion: 2022-01-01
• First posted: 2020-10-09
• Last updated: 2023-03-07
• Results posted: 2023-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study