Trial Outcomes & Findings for The Effects of Fractional CO2 Laser on Poikiloderma of Civatte (NCT NCT04581330)

Last Updated: 2023-03-07

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2023-03-07

Participant Flow

The Control Arm assignment consists of the same participants from the intervention arm, but the only difference is that the other half of the participant's neck was considered as the Control which was not treated with the ablative fractional CO2 laser.

Unit of analysis: side of the neck

Participant milestones

Participant milestones
Measure	DEKA SmartXide C02 Laser One half of the subject's neck will be treated with ablative fractional CO2 laser. 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	Control No Intervention: The other half of the subject's neck will not be treated with the ablative fractional CO2 laser.
Overall Study STARTED	10 10	10 10
Overall Study COMPLETED	10 10	10 10
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=10 Participants One half of the subject's neck will be treated with ablative fractional CO2 laser (DEKA SmartXide ). 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. The other half of the subject's neck will not be treated with the ablative fractional CO2 laser.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Outcome measures
Measure	DEKA SmartXide C02 Laser n=10 side of the neck One half of the subject's neck will be treated with ablative fractional CO2 laser. 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	Control n=10 side of the neck No Intervention: The other half of the subject's neck will not be treated with the ablative fractional CO2 laser.
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks Improvement in Dyschromia	11.01 percentage Standard Deviation 14.91	6.03 percentage Standard Deviation 11.94
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks Improvement in Texture	8.51 percentage Standard Deviation 12.69	5.89 percentage Standard Deviation 10.50
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks Lack of Erythema	4.33 percentage Standard Deviation 13.68	2.49 percentage Standard Deviation 11.99

PRIMARY outcome

Timeframe: Baseline, 24 weeks post-treatment

Population: Data were not collected because the plan of doing this assessment was dropped due to the COVID-19 pandemic.

Improvement of Poikiloderma of Civatte (POC) at 24 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks post-treatment

Population: The Control Arm assignment consists of the same participants from the intervention arm, but the only difference is that the other half of the participant's neck was considered as the Control which was not treated with the ablative fractional CO2 laser. Hence satisfaction assessment was done only once with this set of participants and no data available to report in the Control arm.

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.

Outcome measures

Outcome measures
Measure	DEKA SmartXide C02 Laser n=10 Participants One half of the subject's neck will be treated with ablative fractional CO2 laser. 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	Control No Intervention: The other half of the subject's neck will not be treated with the ablative fractional CO2 laser.
Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment	4.5 score on a scale Standard Deviation 0.53	—

SECONDARY outcome

Timeframe: 24 weeks post-treatment

Population: Data were not collected because the plan of doing this assessment was dropped due to the COVID-19 pandemic.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks post-laser treatment

Population: The Control Arm consists of the same participants from the intervention arm, but the only difference is that the other half of the participant's neck was considered as the Control which was not treated with the ablative fractional CO2 laser.

Number of at least one procedure-related adverse events \>=Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v4.0

Outcome measures

Outcome measures
Measure	DEKA SmartXide C02 Laser n=10 side of the neck One half of the subject's neck will be treated with ablative fractional CO2 laser. 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	Control n=10 side of the neck No Intervention: The other half of the subject's neck will not be treated with the ablative fractional CO2 laser.
Number of at Least One Procedure-related Adverse Events	0 events	0 events

Adverse Events

DEKA SmartXide C02 Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heather Goff

UT Southwestern Medical Center

Phone: 2146484229

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place