Clinical trial NCT04581330: The Effects of Fractional CO2 Laser on Poikiloderma of Civatte
Official title: The Effects of Fractional CO2 Laser on Poikiloderma of Civatte
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poikiloderma of Civatte
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 24 Weeks
timeFrame: Baseline, 24 weeks post-treatment
Secondary outcomes:
measure: Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment
timeFrame: 12 weeks post-treatment
measure: Patient Satisfaction Assessment Scores at 24 Weeks Post Treatment
timeFrame: 24 weeks post-treatment
measure: Number of at Least One Procedure-related Adverse Events
timeFrame: 24 weeks post-laser treatment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas at Southwestern Medical Center
name: Heather W Goff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.