The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
DEKA SmartXide C02 laser	DEKA SmartXide C02 laser	One half of the subject's neck will be treated with ablative fractional CO2 laser.

Primary Outcome Measures

Name	Time	Method
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks	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).
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 24 Weeks	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 Outcome Measures

Name	Time	Method
Patient Satisfaction Assessment Scores at 24 Weeks Post Treatment	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.
Number of at Least One Procedure-related Adverse Events	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
Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment	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.