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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEKA SmartXide C02 laser | Experimental | One half of the subject's neck will be treated with ablative fractional CO2 laser. |
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| Control | No Intervention | The other half of the subject's neck will not be treated with the ablative fractional CO2 laser. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEKA SmartXide C02 laser | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 12 weeks |
| 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) | Baseline, 24 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks post-treatment |
| Patient Satisfaction Assessment Scores at 24 Weeks Post Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather W Goff, MD | University of Texas at Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15987290 | Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control | No Intervention: The other half of the subject's neck will not be treated with the ablative fractional CO2 laser. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | percentage | Baseline, 12 weeks | side of the neck | side of the neck |
|
From Baseline up to 6 months post-treatment
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 compared to the other side of the neck which underwent intervention. The unit of assignment is "side of the neck" for each arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heather Goff | UT Southwestern Medical Center | 2146484229 | heather.goff@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2020 | Dec 15, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2020 | Dec 12, 2022 | ICF_001.pdf |
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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. |
| 24 weeks post-treatment |
| 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 | 24 weeks post-laser treatment |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | No Intervention: The other half of the subject's neck will not be treated with the ablative fractional CO2 laser. |
|
|
| 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) | Data were not collected because the plan of doing this assessment was dropped due to the COVID-19 pandemic. | Posted | Baseline, 24 weeks post-treatment | side of the neck | side of the neck |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post-treatment |
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|
|
| 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. | Data were not collected because the plan of doing this assessment was dropped due to the COVID-19 pandemic. | Posted | 24 weeks post-treatment |
|
|
| 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 | 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. | Posted | Number | events | 24 weeks post-laser treatment | side of the neck | side of the neck |
|
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control | No Intervention was involved in the Control Arm since the other half of the subject's neck was considered as the Control which was not treated with the ablative fractional CO2 laser | 0 | 10 | 0 | 10 | 0 | 10 |
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