NCT00970671

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

1.2 years

First QC Date

September 1, 2009

Last Update Submit

October 20, 2012

Conditions

Keywords

scarlaser therapylasers, pulsed dye

Outcome Measures

Primary Outcomes (1)

  • Vancouver Scar Scale score

    6weeks, 10weeks, and 18weeks after surgery

Secondary Outcomes (2)

  • Subjective rating of pain on scale of 0 to 10

    at each treatment visit: 2weeks, 6weeks, and 10weeks after surgery

  • Cosmetic appearance of scar

    6weeks, 10 weeks, and 18weeks after surgery

Interventions

Pulsed dye laser treatment at purpuric settings with pulse duration of 1.5msec.

Also known as: Pulsed dye laser, 595nm VBeam, Candela

Pulsed dye laser treatment with nonpurpuric settings with pulse duration 10msec.

Also known as: Pulsed dye laser, 595nm VBeam, Candela

No laser treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Location of excision or Mohs surgery on the genitals, hands, or feet.
  • Fitzpatrick skin type V or VI.
  • Prior history of known light sensitivity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Perlman Ambulatory Center - Dermatology clinic

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Julie A Gladsjo, MD PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR
  • S. Brian Jiang, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations