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The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

NCT04581330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-07

Study results available
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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

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

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Heather W Goff, MD · University of Texas at Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-12-15
Completion
2022-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04581330 on ClinicalTrials.gov