The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

NCT04581330 | Completed Results FDA Device

• 1 other identifier: STU-2020-0827
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment

  12 weeks post-treatment

• Patient Satisfaction Assessment Scores at 24 Weeks Post Treatment

  24 weeks post-treatment

• Number of at Least One Procedure-related Adverse Events

  24 weeks post-laser treatment

Study Arms (2)

DEKA SmartXide C02 laser

EXPERIMENTAL

One half of the subject's neck will be treated with ablative fractional CO2 laser.

Device: DEKA SmartXide C02 laser

Control

NO INTERVENTION

The other half of the subject's neck will not be treated with the ablative fractional CO2 laser.

Interventions

DEKA SmartXide C02 laser DEVICE

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

DEKA SmartXide C02 laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 15987290 BACKGROUND

Results Point of Contact

• Title: Dr. Heather Goff
• Organization: UT Southwestern Medical Center

heather.goff@utsouthwestern.edu

2146484229

Study Officials

• Heather W Goff, MD

  University of Texas at Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 9, 2020
• Study Start: April 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: January 1, 2022
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2023-02

Locations

US (1)