Poikiloderma of Civatte
Conditions
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.
Interventions
DEVICEDEKA 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
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks | 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). |
| Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 24 Weeks | Baseline, 24 weeks post-treatment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment | 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. |
| Patient Satisfaction Assessment Scores at 24 Weeks Post Treatment | 24 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. |
| Number of at Least One Procedure-related Adverse Events | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 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).
Time frame: Baseline, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DEKA SmartXide C02 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 |
| DEKA SmartXide C02 Laser | Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks | Improvement in Texture | 8.51 percentage | Standard Deviation 12.69 |
| DEKA SmartXide C02 Laser | Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks | Lack of Erythema | 4.33 percentage | Standard Deviation 13.68 |
| Control | Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks | Improvement in Dyschromia | 6.03 percentage | Standard Deviation 11.94 |
| Control | Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks | Improvement in Texture | 5.89 percentage | Standard Deviation 10.5 |
| Control | Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks | Lack of Erythema | 2.49 percentage | Standard Deviation 11.99 |
Primary
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 24 Weeks
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)
Time frame: 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.
Secondary
Number of at Least One Procedure-related Adverse Events
Number of at least one procedure-related adverse events \>=Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v4.0
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEKA SmartXide C02 Laser | Number of at Least One Procedure-related Adverse Events | 0 events |
| Control | Number of at Least One Procedure-related Adverse Events | 0 events |
Secondary
Patient Satisfaction Assessment Scores at 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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEKA SmartXide C02 Laser | Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment | 4.5 score on a scale | Standard Deviation 0.53 |
Secondary
Patient Satisfaction Assessment Scores at 24 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.
Time frame: 24 weeks post-treatment
Population: Data were not collected because the plan of doing this assessment was dropped due to the COVID-19 pandemic.