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Completed

NCT Number: NCT04581330

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.

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Key information

Conditions

Poikiloderma of Civatte

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks

    Time frame: Baseline, 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).

  2. Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 24 Weeks

    Time frame: Baseline, 24 weeks post-treatment

    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)

Secondary outcomes

  1. Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment

    Time frame: 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.

  2. Patient Satisfaction Assessment Scores at 24 Weeks Post Treatment

    Time frame: 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.

  3. Number of at Least One Procedure-related Adverse Events

    Time frame: 24 weeks post-laser treatment

    Number of at least one procedure-related adverse events >=Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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