Poikiloderma of CivatteNCT04581330

The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

A study testing DEKA SmartXide C02 laser in people with Poikiloderma of Civatte, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Poikiloderma of Civatte
What is being tested?: DEKA SmartXide C02 laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2021to 1 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

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.

Conditions: Poikiloderma of Civatte
Being tested: DEKA SmartXide C02 laser

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DEKA SmartXide C02 laserDevice
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

Study groups in NCT04581330
Study group	Role	What they receive
DEKA SmartXide C02 laser	Experimental	One half of the subject's neck will be treated with ablative fractional CO2 laser. Receives: Device: DEKA SmartXide C02 laser
Control	No intervention	The other half of the subject's neck will not be treated with the ablative fractional CO2 laser.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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)
Measured: Baseline, 24 weeks post-treatment

Secondary outcomes (3)

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.
Measured: 12 weeks post-treatment
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.
Measured: 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
Measured: 24 weeks post-laser treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20211 Jan 2022

First posted9 Oct 2020
Study start1 Apr 2021
Primary completion15 Dec 2021
Study completion1 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Poikiloderma of CivatteStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04581330
Sponsor's protocol ID: STU-2020-0827
Status last verified: Feb 2023
First submitted: 2 Oct 2020
Last updated: 7 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 15987290

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Fractional CO2 Laser on Poikiloderma of Civatte
ClinicalTrials.gov ID: NCT04581330
Acronym / sponsor ID: STU-2020-0827
Conditions: Poikiloderma of Civatte
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Study start: 1 Apr 2021 (actual)
Primary completion: 15 Dec 2021 (actual)
Study completion: 1 Jan 2022 (actual)
First posted: 9 Oct 2020 (actual)
Results: Posted 7 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DEKA SmartXide C02 laser	Experimental	Device: DEKA SmartXide C02 laserOne half of the subject's neck will be treated with ablative fractional CO2 laser.
Control	No intervention	–The other half of the subject's neck will not be treated with the ablative fractional CO2 laser.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DEKA SmartXide C02 laserOne 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	Device	DEKA SmartXide C02 laser

Primary outcome

Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks
Time frame: 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
Time frame: 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)

3 secondary outcomes

Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment
Time frame: 12 weeks post-treatment
Patient Satisfaction Assessment Scores at 24 Weeks Post Treatment
Time frame: 24 weeks post-treatment
Number of at Least One Procedure-related Adverse Events
Time frame: 24 weeks post-laser treatment

Results and safety

Results posted to the registry on 7 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DEKA SmartXide C02 Laser	10	10
Control	10	10

Primary outcome: Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks

Time frame: Baseline, 12 weeks. Mean (Standard Deviation). Unit: percentage

Measure	DEKA SmartXide C02 Laser n = 10	Control n = 10
Improvement in Dyschromia	11.01 (14.91)	6.03 (11.94)
Improvement in Texture	8.51 (12.69)	5.89 (10.50)
Lack of Erythema	4.33 (13.68)	2.49 (11.99)

Primary outcome: Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 24 Weeks

Time frame: Baseline, 24 weeks post-treatment

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline up to 6 months post-treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DEKA SmartXide C02 Laser	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Control	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15987290Katoulis 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heather W Goff, MD principal investigator

University of Texas at Southwestern Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DEKA SmartXide C02 laser in people with Poikiloderma of Civatte, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks (time frame: Baseline, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04581330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.