18 and older, any sex, with Poikiloderma of Civatte. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 WeeksPrimary· Baseline, 12 weeks
Improvement of Poikiloderma of Civatte (POC) at 12 weeks post treatment is assessed by the Physician's Global Aesthetic Improvement Scale which is a 10-point scale. Each dermatologist from an independent panel (blinded to treatment parameters and the treatment laterality at each photograph time point) will be asked to identify the baseline and post-treatment images from randomized, paired images for all subjects. Reviewers will rate improvement of POC in 10% increments on a 10-point scale (0% no improvement to 100% or complete clearance).
Improvement in Dyschromia
Group
Value
95% CI
DEKA SmartXide C02 Laser
11.01
± 14.91
Control
6.03
± 11.94
Improvement in Texture
Group
Value
95% CI
DEKA SmartXide C02 Laser
8.51
± 12.69
Control
5.89
± 10.50
Lack of Erythema
Group
Value
95% CI
DEKA SmartXide C02 Laser
4.33
± 13.68
Control
2.49
± 11.99
Patient Satisfaction Assessment Scores at 12 Weeks Post TreatmentSecondary· 12 weeks post-treatment
Subjects will assess satisfaction with change of POC using the Global Aesthetic Improvement Scale which is a 5-point satisfaction scale. Scale ranges from 1 to 5, lower score indicating lower satisfaction.
Group
Value
95% CI
DEKA SmartXide C02 Laser
4.5
± 0.53
Number of at Least One Procedure-related Adverse EventsSecondary· 24 weeks post-laser treatment
Number of at least one procedure-related adverse events \>=Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v4.0
Group
Value
95% CI
DEKA SmartXide C02 Laser
0
Control
0
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 7 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04581330.