Cherry Angioma Clinical Trial
Official title:
Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata
| Verified date | February 2015 |
| Source | Northwestern University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | October 2007 |
| Est. primary completion date | October 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 95 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Northwestern University | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Northwestern University |
United States,
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. A — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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). | Baseline and 3 months | No |