CompletedNot Applicable

The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

United States10 participantsStarted 2021-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, 12 weeks

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

Timeframe: Baseline, 24 weeks post-treatment

Trial details

NCT IDNCT04581330

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-15

Results submitted2022-12-15

View on ClinicalTrials.gov More Poikiloderma of Civatte trials