Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata

NCT00791908 | Completed Results

• 1 other identifier: MA-STU81
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cherry Angioma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

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.

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.

Procedure: potassium titanyl phosphate (KTP)

Interventions

Electrodessication PROCEDURE

Treatment applied to a third of the torso at each study visit.

electrodessication (ED)

Pulsed dye laser (PDL) PROCEDURE

Laser treatment applied to a third of the torso at each study visit.

pulsed dye laser (PDL)

potassium titanyl phosphate (KTP) PROCEDURE

Laser treatment applied to a third of the torso at each study visit.

potassium titanyl phosphate (KTP) laser

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 20083690 RESULT

MeSH Terms

Interventions

Lasers, Dye; potassium titanylphosphate

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Limitations and Caveats

Absence of a cost analysis; all the participants were white; only one set of parameters (ie, for lasers, pulse duration and fluence; and for electrodesiccation, energy level) was used for treatment with each modality.

Results Point of Contact

• Title: Murad Alam, MD
• Organization: Northwestern University

m-alam@northwestern.edu

312-695-6785

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 17, 2008
• Study Start: September 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: March 6, 2015
• Results First Posted: December 21, 2010

Record last verified: 2015-02

Locations

US (1)