Cherry Angioma
Conditions
Brief 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. 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.
Interventions
PROCEDUREElectrodessication
Treatment applied to a third of the torso at each study visit.
PROCEDUREPulsed dye laser (PDL)
Laser treatment applied to a third of the torso at each study visit.
PROCEDUREpotassium titanyl phosphate (KTP)
Laser treatment applied to a third of the torso at each study visit.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 48 years |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
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).
Time frame: Baseline and 3 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Electrodesiccation (ED) | 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 | Texture of Cherry Angiomata | 4.24 Units on a scale |
| Electrodesiccation (ED) | 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 | Color of Cherry Angiomata | 5.27 Units on a scale |
| Electrodesiccation (ED) | 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 | Size of Cherry Angiomata | 3.40 Units on a scale |
| KTP Laser | 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 | Texture of Cherry Angiomata | 3.42 Units on a scale |
| KTP Laser | 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 | Color of Cherry Angiomata | 4.99 Units on a scale |
| KTP Laser | 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 | Size of Cherry Angiomata | 3.44 Units on a scale |
| Pulsed-dye Laser (PDL) | 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 | Color of Cherry Angiomata | 5.19 Units on a scale |
| Pulsed-dye Laser (PDL) | 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 | Size of Cherry Angiomata | 3.31 Units on a scale |
| Pulsed-dye Laser (PDL) | 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 | Texture of Cherry Angiomata | 3.24 Units on a scale |