Spider AngiomaNCT02755467
Clinical Evaluation of the Treatment of Spider Angioma
A study testing KTP laser in people with Spider Angioma, run by Cutera Inc. at 1 site in United States.
Trial summary
To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas. Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spider Angioma
- What is being tested?
- KTP laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2016to 4 Apr 2017
- 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 5 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males or females, 5 to 65 years of age (inclusive).
- Fitzpatrick Skin Types I-IV
- Subject must be able to read, understand and sign the Informed Consent Form.
- If subject is a minor (<18 years old in Illinois), Assent must be obtained from the subject and a Parental Consent Form must be signed by the parents or legal guardian.
- Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- Willing to have limited sun exposure for the duration of the study, including the follow-up period.
- Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes
- Agree not to undergo any other procedure for the treatment of spider angioma during the study.
Who cannot join
- Pregnant.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.
- History of seizure disorders due to light.
- Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within 3 months prior to enrollment or during the study.
- In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy
To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of the 532 nm KTP laser within the Cutera Excel V system for the treatment of spider angiomas.
- Conditions
- Spider Angioma
- Being tested
- KTP laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KTP laserDevice
Also called Cutera Excel V
Dual Wavelength Laser Emitting 532 nm Laser Energy
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s). Receives: Device: KTP laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment Scale for Improvement of Spider Angioma
Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale.
High scores indicate better outcomes:
- None
- Mild
- Moderate
- Significant
- Very Significant
- Complete Removal
Measured: Four 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.
- First posted29 Apr 2016 (estimated)
- Study start26 May 2016
- Primary completion13 Jan 2017
- Study completion4 Apr 2017
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 Spider AngiomaStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelly Stankiewicz, MD FAAD, Principal investigator, DuPage Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755467
- Sponsor's protocol ID
- C-16-EV08
- Status last verified
- Feb 2023
- First submitted
- 25 Apr 2016
- Last updated
- 24 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy
- ClinicalTrials.gov ID
- NCT02755467
- Acronym / sponsor ID
- C-16-EV08
- Conditions
- Spider Angioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- 26 May 2016 (actual)
- Primary completion
- 13 Jan 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 24 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of the 532 nm KTP laser within the Cutera Excel V system for the treatment of spider angiomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Device: KTP laserEach subject will receive a 532 nm KTP laser treatment for their spider angioma(s). |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females, 5 to 65 years of age (inclusive).
- Fitzpatrick Skin Types I-IV
- Subject must be able to read, understand and sign the Informed Consent Form.
- If subject is a minor (<18 years old in Illinois), Assent must be obtained from the subject and a Parental Consent Form must be signed by the parents or legal guardian.
- Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
Key exclusion criteria (8 listed)
- Pregnant.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.
- History of seizure disorders due to light.
- Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
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 |
|---|---|---|
| KTP laserAlso: Cutera Excel VDual Wavelength Laser Emitting 532 nm Laser Energy | Device | Laser treatment |
Primary outcome
Physician's Global Assessment Scale for Improvement of Spider Angioma
Time frame: Four weeks post laser treatment.
Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale. High scores indicate better outcomes: 0. None 1. Mild 2. Moderate 3. Significant 4. Very Significant 5. Complete Removal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Kelly Stankiewicz, MD FAAD principal investigator
DuPage Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KTP laser in people with Spider Angioma, 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 8 inclusion and 8 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 24 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 24 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?
Physician's Global Assessment Scale for Improvement of Spider Angioma (time frame: Four weeks post laser treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2023.