N/A
N=20
The Effects of Fractional CO2 Laser on Poikiloderma of Civatte
Poikiloderma of Civatte
Bottom Line
View on ClinicalTrials.gov: NCT04581330 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks — 11.01; 6.03; 8.51; 5.89 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DEKA SmartXide C02 laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks |
11.01; 6.03; 8.51; 5.89; 4.33; 2.49 | — |
| PRIMARY Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 24 Weeks |
— | — |
| SECONDARY Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment |
4.5 | — |
| SECONDARY Patient Satisfaction Assessment Scores at 24 Weeks Post Treatment |
— | — |
| SECONDARY Number of at Least One Procedure-related Adverse Events |
0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04581330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.