The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

NCT ID: NCT04581330

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DEKA SmartXide C02 laser

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

Group Type: EXPERIMENTAL

DEKA SmartXide C02 laser

Intervention Type: 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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DEKA SmartXide C02 laser

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Heather Woodworth Goff

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather W Goff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15987290 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU-2020-0827

Identifier Type: -

Identifier Source: org_study_id