The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

The University of Texas System (UT)

Status: Completed

Conditions: Poikiloderma of Civatte

Treatments: Device: DEKA SmartXide C02 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04581330

STU-2020-0827

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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10 participants in 2 patient groups

DEKA SmartXide C02 laser

Experimental group

Description:

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

Treatment:

Device: DEKA SmartXide C02 laser

Control

No Intervention group

Description:

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