Cherry AngiomaNCT00791908
Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata
A study testing Electrodessication, Pulsed dye laser (PDL) and potassium titanyl phosphate (KTP) in people with Cherry Angioma, run by Northwestern University at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether laser treatments over 6 weeks using the pulsed dye laser system or the potassium titanyl phosphate (KTP) laser are effective in patients with cherry angiomas as observed by a physician provider and the subject. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cherry Angioma
- What is being tested?
- Electrodessication, Pulsed dye laser (PDL) and potassium titanyl phosphate (KTP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Oct 2007
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 95 years.
- Have at least 12 cherry angiomas (4 per each third of the torso) that have been documented.
- The subjects are in medically stable condition.
- The subject has willingness and the ability to understand and provide informed consent for the procedure and is able to communicate with the investigator.
- Must be willing not to employ other treatment options for cherry angiomas during the course of this study.
Who cannot join
- Under 18 years of age and over 95 years of age
- Pregnancy or lactation.
- Subjects who are unable to understand the protocol or to give informed consent.
- Subjects cannot have had previous laser treatment in the last 6 months before enrollment.
- Subjects have a cardiac defibrillator or pacemakers that may interact with the electrodesiccation technique.
- Subjects have no serious medical conditions that would contradict participation in the research.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to determine whether laser treatments over 6 weeks using the pulsed dye laser system or the potassium titanyl phosphate (KTP) laser are effective in patients with cherry angiomas as observed by a physician provider and the subject.
The investigators hypothesize that the two laser treatments will be an effective tool for treating cherry angiomas. The investigators aim to compare these modalities to electrodessication, as all three modalities are considered the current standard of care. Electrodessication can result in atrophic lesions at the site of the treated cherry angiomas.
In summary, the goal of this project is to compare the non-ablative pulsed dye laser and the AuraTM potassium titanyl phosphate (KTP) laser to each other and to the current standard of care, electrodessication.
- Conditions
- Cherry Angioma
- Being tested
- Electrodessication, Pulsed dye laser (PDL), potassium titanyl phosphate (KTP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrodessicationProcedure or surgery
Treatment applied to a third of the torso at each study visit.
Pulsed dye laser (PDL)Procedure or surgery
Laser treatment applied to a third of the torso at each study visit.
potassium titanyl phosphate (KTP)Procedure or surgery
Laser treatment applied to a third of the torso at each study visit.
| Study group | Role | What they receive |
|---|---|---|
| electrodessication (ED) | Experimental | Treatment over 6 weeks using electrodessication (ED) to remove cherry angiomas. Each participant received treatment with PDL, KTP laser, and electrodesiccation to separate randomly selected areas on the torso, with each area bearing 4 cherry angiomata. Receives: Procedure: Electrodessication |
| pulsed dye laser (PDL) | Experimental | Treatment over 6 weeks using pulsed dye laser (PDL) to remove cherry angiomas. Each participant received treatment with PDL, KTP laser, and electrodesiccation to separate randomly selected areas on the torso, with each area bearing 4 cherry angiomata. Receives: Procedure: Pulsed dye laser (PDL) |
| potassium titanyl phosphate (KTP) laser | Experimental | Treatment over 6 weeks using potassium titanyl phosphate (KTP) laser to remove cherry angiomas. Each participant received treatment with PDL, KTP laser, and electrodesiccation to separate randomly selected areas on the torso, with each area bearing 4 cherry angiomata. Receives: Procedure: potassium titanyl phosphate (KTP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters
Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startSep 2006
- Primary completionOct 2007
- Study completionOct 2007
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 Cherry AngiomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791908
- Sponsor's protocol ID
- MA-STU81
- Status last verified
- Feb 2015
- First submitted
- 14 Nov 2008
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Collyer J, Boone SL, White LE, Rademaker A, West DP, Anderson K, Kim NA, Smith S, Yoo S, Alam M. Comparison of treatment of cherry angiomata with pulsed-dye laser, potassium titanyl phosphate laser, and electrodesiccation: a randomized controlled trial. Arch Dermatol. 2010 Jan;146(1):33-7. doi: 10.1001/archdermatol.2009.318.
PubMed 20083690
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata
- ClinicalTrials.gov ID
- NCT00791908
- Acronym / sponsor ID
- MA-STU81
- Conditions
- Cherry Angioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Posted 21 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine whether laser treatments over 6 weeks using the pulsed dye laser system or the potassium titanyl phosphate (KTP) laser are effective in patients with cherry angiomas as observed by a physician provider and the subject.
The investigators hypothesize that the two laser treatments will be an effective tool for treating cherry angiomas. The investigators aim to compare these modalities to electrodessication, as all three modalities are considered the current standard of care. Electrodessication can result in atrophic lesions at the site of the treated cherry angiomas.
In summary, the goal of this project is to compare the non-ablative pulsed dye laser and the AuraTM potassium titanyl phosphate (KTP) laser to each other and to the current standard of care, electrodessication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| electrodessication (ED) | Experimental | Procedure: ElectrodessicationTreatment over 6 weeks using electrodessication (ED) to remove cherry angiomas. Each participant received treatment with PDL, KTP laser, and electrodesiccation to separate randomly selected areas on the torso, with each area bearing 4 cherry angiomata. |
| pulsed dye laser (PDL) | Experimental | Procedure: Pulsed dye laser (PDL)Treatment over 6 weeks using pulsed dye laser (PDL) to remove cherry angiomas. Each participant received treatment with PDL, KTP laser, and electrodesiccation to separate randomly selected areas on the torso, with each area bearing 4 cherry angiomata. |
| potassium titanyl phosphate (KTP) laser | Experimental | Procedure: potassium titanyl phosphate (KTP)Treatment over 6 weeks using potassium titanyl phosphate (KTP) laser to remove cherry angiomas. Each participant received treatment with PDL, KTP laser, and electrodesiccation to separate randomly selected areas on the torso, with each area bearing 4 cherry angiomata. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 95 years.
- Have at least 12 cherry angiomas (4 per each third of the torso) that have been documented.
- The subjects are in medically stable condition.
- The subject has willingness and the ability to understand and provide informed consent for the procedure and is able to communicate with the investigator.
- Must be willing not to employ other treatment options for cherry angiomas during the course of this study.
Key exclusion criteria (6 listed)
- Under 18 years of age and over 95 years of age
- Pregnancy or lactation.
- Subjects who are unable to understand the protocol or to give informed consent.
- Subjects cannot have had previous laser treatment in the last 6 months before enrollment.
- Subjects have a cardiac defibrillator or pacemakers that may interact with the electrodesiccation technique.
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 |
|---|---|---|
| ElectrodessicationTreatment applied to a third of the torso at each study visit. | Procedure or surgery | electrodessication (ED) |
| Pulsed dye laser (PDL)Laser treatment applied to a third of the torso at each study visit. | Procedure or surgery | pulsed dye laser (PDL) |
| potassium titanyl phosphate (KTP)Laser treatment applied to a third of the torso at each study visit. | Procedure or surgery | potassium titanyl phosphate (KTP) laser |
Primary outcome
Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters
Time frame: Baseline and 3 months
Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20083690Collyer J, Boone SL, White LE, Rademaker A, West DP, Anderson K, Kim NA, Smith S, Yoo S, Alam M. Comparison of treatment of cherry angiomata with pulsed-dye laser, potassium titanyl phosphate laser, and electrodesiccation: a randomized controlled trial. Arch Dermatol. 2010 Jan;146(1):33-7. doi: 10.1001/archdermatol.2009.318.
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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrodessication, Pulsed dye laser (PDL) and potassium titanyl phosphate (KTP) in people with Cherry Angioma, run by Northwestern University 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 5 inclusion and 6 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 6 Mar 2015. 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 21 Dec 2010). 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?
Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters (time frame: Baseline and 3 months). 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 NCT00791908, 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 6 Mar 2015.