Treatment of Surgical Scars Using the Pulsed Dye Laser

Scar Clinical Trial

Official title:

Treatment of Surgical Scars With the 595nm Pulsed Dye Laser Using Purpuric and Nonpurpuric Parameters: A Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970671
• Other study ID #: 090690
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: October 20, 2012
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2012
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether treatment of fresh surgical scars with a pulsed dye laser using purpura-inducing settings will improve clinical appearance better than one using non-purpura-inducing settings or no treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients requiring Mohs micrographic surgery or excisions for skin cancer or atypical nevi, with an expected post-excision scar of 4.5cm in length or more.

• Willing to participate.

• Able to give informed consent

Exclusion Criteria:

• Location of excision or Mohs surgery on the genitals, hands, or feet.

• Fitzpatrick skin type V or VI.

• Prior history of known light sensitivity.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laser Therapy
• Scar

Intervention

Other:
• Laser treatment with Purpuric settings
Pulsed dye laser treatment at purpuric settings with pulse duration of 1.5msec.
• Laser treatment with Nonpurpuric settings
Pulsed dye laser treatment with nonpurpuric settings with pulse duration 10msec.
• No treatment
No laser treatment

Locations

Country	Name	City	State
United States	UCSD Perlman Ambulatory Center - Dermatology clinic	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vancouver Scar Scale score		6weeks, 10weeks, and 18weeks after surgery	No
Secondary	Subjective rating of pain on scale of 0 to 10		at each treatment visit: 2weeks, 6weeks, and 10weeks after surgery	No
Secondary	Cosmetic appearance of scar		6weeks, 10 weeks, and 18weeks after surgery	No