The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

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.

Study Overview

• Status: Completed
• Conditions: Poikiloderma of Civatte
• Intervention / Treatment: Device: DEKA SmartXide C02 laser

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects, English and non-English speakers, and subjects more than 18 years old
• Clinical diagnosis of poikiloderma of Civatte affecting the neck and chest
• Agree to not undergo any other procedures on the neck and chest area during the study
• Agree to refrain from tanning for 6 months post-procedure
• Willing and able to read, understand, and sign the consent form
• Willing and able to adhere to the treatment and follow-up schedule as well as post-treatment care

Exclusion Criteria:

• Patients under 18 years old
• Active skin infection, dermatitis, or a rash on the treatment area
• Pregnant or lactating patients
• Patients on immunosuppressive medications
• Any laser procedures or chemical peel procedures on the neck or chest area within the past 6 months
• Patients with multiple comorbidities such as diabetes mellitus, cardiovascular diseases, neurologic disorders, internal malignancies
• Personal history or family history of forming keloids or hypertrophic scars, or abnormal wound healing
• Patients with known bleeding disorders or taking more than one anticoagulation medications
• Undergoing any surgery in the treatment area within the past 12 months
• History of radiation to the head, neck, and chest area
• Systemic use of isotretinoin within 6 months
• Any use of gold therapy
• Current smoker or history of smoking within 12 months of study
• Any physical or mental condition in which the investigators deem unsafe for the subject to participate in the study.
• History of recurrent herpes simplex on the neck or chest.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEKA SmartXide C02 laser; One half of the subject's neck will be treated with ablative fractional CO2 laser.	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
No Intervention: Control; The other half of the subject's neck will not be treated with the ablative fractional CO2 laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks	Improvement of Poikiloderma of Civatte (POC) at 12 weeks post treatment is assessed by the Physician's Global Aesthetic Improvement Scale which is a 10-point scale. Each dermatologist from an independent panel (blinded to treatment parameters and the treatment laterality at each photograph time point) will be asked to identify the baseline and post-treatment images from randomized, paired images for all subjects. Reviewers will rate improvement of POC in 10% increments on a 10-point scale (0% no improvement to 100% or complete clearance).	Baseline, 12 weeks
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 24 Weeks	Improvement of Poikiloderma of Civatte (POC) at 24 weeks post treatment is assessed by the Physician's Global Aesthetic Improvement Scale which is a 10-point scale. Each dermatologist from an independent panel (blinded to treatment parameters and the treatment laterality at each photograph time point) will be asked to identify the baseline and post-treatment images from randomized, paired images for all subjects. Reviewers will rate improvement of POC in 10% increments on a 10-point scale (0% no improvement to 100% or complete clearance)	Baseline, 24 weeks post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment	Subjects will assess satisfaction with change of POC using the Global Aesthetic Improvement Scale which is a 5-point satisfaction scale. Scale ranges from 1 to 5, lower score indicating lower satisfaction.	12 weeks post-treatment
Patient Satisfaction Assessment Scores at 24 Weeks Post Treatment	Subjects will assess satisfaction with change of POC using the Global Aesthetic Improvement Scale which is a 5-point satisfaction scale. Scale ranges from 1 to 5, lower score indicating lower satisfaction.	24 weeks post-treatment
Number of at Least One Procedure-related Adverse Events	Number of at least one procedure-related adverse events >=Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v4.0	24 weeks post-laser treatment

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Heather W Goff, MD, University of Texas at Southwestern Medical Center

Publications and helpful links

General Publications

• Katoulis AC, Stavrianeas NG, Georgala S, Bozi E, Kalogeromitros D, Koumantaki E, Katsambas AD. Poikiloderma of Civatte: a clinical and epidemiological study. J Eur Acad Dermatol Venereol. 2005 Jul;19(4):444-8. doi: 10.1111/j.1468-3083.2005.01213.x.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STU-2020-0827

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No