NCT00482144

Brief Summary

The purpose of this study is to compare the effects of the pulsed-dye laser (PDL) at two different wavelengths, 585nm and 595nm, in the treatment of post-surgical scars starting on suture-removal day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

July 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

4.5 years

First QC Date

June 1, 2007

Last Update Submit

June 26, 2016

Conditions

CicatrixScars

Keywords

Pulsed-Dye Laser

Outcome Measures

Primary Outcomes (1)

  • Vancouver Scar Scale Visual Analog Scale

    9 months

Secondary Outcomes (2)

  • Visual Analog Scale

    9 months

  • Blinded Evaluator assessments

    9 months

Study Arms (3)

Treatment: PDL 450 microseconds

ACTIVE COMPARATOR

The scar will be randomly divided into three equal fields. One third of the scar will receive PDL using a 7 mm spot size at 4.0 J (Joules) for 450 microseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.

Procedure: PDL 450 microseconds

Treatment: PDL 1.5 milliseconds

ACTIVE COMPARATOR

The scar will be randomly divided into three equal fields. One third of the scar will receive PDL using a 7 mm spot size at 4.0 J (Joules) for 1.5 milliseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.

Procedure: PDL 1.5 milliseconds

Control

NO INTERVENTION

The scar will be randomly divided into three equal fields. One third of the scar will not receive treatment

Interventions

PDL 450 microsecondsPROCEDURE

The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 585 nm using a 7 mm spot size at 4.0 J (Joules) for 450 microseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.

Treatment: PDL 450 microseconds
PDL 1.5 millisecondsPROCEDURE

The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 585 nm using a 7 mm spot size at 4.0 J (Joules) for 1.5 milliseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.

Treatment: PDL 1.5 milliseconds

Eligibility Criteria

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

You may qualify if:

  • Age 18-65
  • Postoperative linear scars greater than 6 cm
  • Skin photo-types I-IV

You may not qualify if:

  • Patient should not be taking any systemic, topical, or intralesional treatment of the scars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • Nouri K, Jimenez GP, Harrison-Balestra C, Elgart GW. 585-nm pulsed dye laser in the treatment of surgical scars starting on the suture removal day. Dermatol Surg. 2003 Jan;29(1):65-73; discussion 73. doi: 10.1046/j.1524-4725.2003.29014.x.

    PMID: 12534515BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Keyvan Nouri, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 4, 2007

Study Start

July 1, 2003

Primary Completion

January 1, 2008

Study Completion

May 1, 2008

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

US(1)