Poikiloderma of CivatteNCT01491620

Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

A study testing 532 nm KTP laser in people with Poikiloderma of Civatte and Dyschromia, run by Cutera Inc. 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

This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte). Read more about this study

Who is it for?: Ages 35 to 65 years
Conditions the study is for: Poikiloderma of Civatte, Dyschromia, Pigmentation Disorders
What is being tested?: 532 nm KTP laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Nov 2011to May 2013
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 35 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Fitzpatrick Skin Type I - III
Clinical diagnosis of poikiloderma of Civatte affecting the neck and/or chest
Willing to refrain from using topical corticosteroids, retinoids and bleaching agents on the treated area
Agree not to undergo any other procedure for the treatment of poikiloderma of Civatte during the study
Willing and able to read, understand and sign the Informed Consent Form
Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions

Who cannot join

Any laser treatment on neck and/or chest within 12 months
Any topical treatment on neck and/or chest within 6 months
Pregnant and/or breastfeeding
Infection, dermatitis or a rash in the treatment area
Suffering from significant concurrent illness, such as Diabetes Mellitus or pertinent neurological disorders
History of seizure disorders due to light, fibromyalgia, connective tissue disease, vitiligo, psoriasis, pigmentary disorders, keloid scarring, hypertrophic scarring or abnormal wound healing

Show all 18Show fewer

History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications
Having a known anticoagulative condition or taking anticoagulation medications
History of diseases stimulated by heat, unless treatment is conducted following a prophylactic regimen
Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely)
History of radiation to the head, neck and/or upper chest
Undergoing systemic chemotherapy for the treatment of cancer
Systemic use of isotretinoin (Accutane®) within 6 months
Any use of gold therapy
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study
Current smoker or history of smoking within 12 months of study
Participation in a study of another device or drug within 6 months
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in study

Trial locations and contacts

1 site in 1 country.

United States1 site

Zel Skin and Laser Specialists
Edina, Minnesota, 55424

Other trials in United States

About this study

Official title: A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).

Conditions: Poikiloderma of Civatte, Dyschromia, Pigmentation Disorders, Telangiectasia, Photosensitivity Disorders
Being tested: 532 nm KTP laser
Keywords: poikiloderma of Civatte, red dyschromia, brown dyschromia, sun damage, neck, chest, dyschromia, pigmentation disorders, erythema, photosensitivity disorders, sun exposure, telangiectasia, hyperpigmentation, hypopigmentation
Medical subject headings: Pigmentation Disorders, Telangiectasis, Photosensitivity Disorders, Erythema, Hyperpigmentation, Hypopigmentation

What participants receive

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

532 nm KTP laserDevice
Also called Excel V
Laser treatment sessions on the neck and/or chest

Study groups in NCT01491620
Study group	Role	What they receive
532 nm KTP laser treatment	Experimental	Not described Receives: Device: 532 nm KTP laser

What is being measured

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

Severity Assessment Score
Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists.
Blinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values
Measured: 24 weeks
Physician's Global Assessment (Blinded)
Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale.
Physician's Global Assessment (min= -1; max=4) Higher scores mean better outcome
Measured: 24 weeks

Timeline

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

Nov 2011May 2013

First posted14 Dec 2011 (estimated)
Study startNov 2011
Primary completionMay 2013
Study completionMay 2013

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.
Other trials for Poikiloderma of CivatteStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01491620
Sponsor's protocol ID: C-11-XPC01
Status last verified: Oct 2022
First submitted: 5 Dec 2011
Last updated: 28 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
ClinicalTrials.gov ID: NCT01491620
Acronym / sponsor ID: C-11-XPC01
Conditions: Poikiloderma of Civatte, Dyschromia, Pigmentation Disorders, Telangiectasia, Photosensitivity Disorders
Keywords: poikiloderma of Civatte, red dyschromia, brown dyschromia, sun damage, neck, chest, dyschromia, pigmentation disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Cutera Inc.Industry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 14 Dec 2011 (estimated)
Results: Posted 28 Oct 2022

Clinical summary

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

This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
532 nm KTP laser treatment	Experimental	Device: 532 nm KTP laser

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Fitzpatrick Skin Type I - III
Clinical diagnosis of poikiloderma of Civatte affecting the neck and/or chest
Willing to refrain from using topical corticosteroids, retinoids and bleaching agents on the treated area
Agree not to undergo any other procedure for the treatment of poikiloderma of Civatte during the study
Willing and able to read, understand and sign the Informed Consent Form

Key exclusion criteria (18 listed)

Any laser treatment on neck and/or chest within 12 months
Any topical treatment on neck and/or chest within 6 months
Pregnant and/or breastfeeding
Infection, dermatitis or a rash in the treatment area
Suffering from significant concurrent illness, such as Diabetes Mellitus or pertinent neurological disorders

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
532 nm KTP laserAlso: Excel VLaser treatment sessions on the neck and/or chest	Device	532 nm KTP laser treatment

Primary outcome

Severity Assessment Score
Time frame: 24 weeks
Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists. Blinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values
Physician's Global Assessment (Blinded)
Time frame: 24 weeks
Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale. Physician's Global Assessment (min= -1; max=4) Higher scores mean better outcome

Results and safety

Results posted to the registry on 28 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
532 nm KTP Laser Treatment	24	24

Primary outcome: Severity Assessment Score

Time frame: 24 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	532 nm KTP Laser Treatment n = 17
Neck	-0.06 (0.66)
Upper Chest	0.2 (0.45)

Population analysed: Only 5 subjects were treated and then assessed at 24 weeks in their upper chest area

Primary outcome: Physician's Global Assessment (Blinded)

Time frame: 24 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	532 nm KTP Laser Treatment n = 17
Neck Area	.06 (.97)
Upper Chest Area	1 (.71)

Population analysed: Only 5 subjects were treated and then assessed at 24 weeks in their upper chest area

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
532 nm KTP Laser Treatment	0 of 24 (0%)	24 of 24 (100%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing 532 nm KTP laser in people with Poikiloderma of Civatte and Dyschromia, run by Cutera Inc. 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 18 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 28 Oct 2022. 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 28 Oct 2022). 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?

Severity Assessment Score (time frame: 24 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 NCT01491620.

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 28 Oct 2022.