NCT00544635

Brief Summary

The goal of this project is to examine the ability of light exposure to improve the appearance of cutaneous scars.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

October 12, 2007

Last Update Submit

July 25, 2014

Conditions

Cutaneous Scars

Outcome Measures

Primary Outcomes (6)

  • Scar vascularity

    24 weeks

  • Scar pigmentation

    24 weeks

  • Scar thickness

    24 weeks

  • Scar length

    24 weeks

  • Scar width

    24 weeks

  • Scar surface area

    24 weeks

Study Arms (2)

A

EXPERIMENTAL

scars will be treated with light

Device: light

B

PLACEBO COMPARATOR

no intervention

Device: no intervention

Interventions

no interventionDEVICE

no intervention

B
lightDEVICE

scars will be treated with light

A

Eligibility Criteria

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

You may qualify if:

  • Have two lesions that have been selected for excision
  • Have two cutaneous scars from previous excisions as part of a standard of care
  • Subjects are in good health
  • Subject has a willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

You may not qualify if:

  • Pregnancy or lactation
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Ultraviolet Therapy

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics

Study Officials

  • Murad Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 16, 2007

Study Start

November 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

US(1)