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Pulsed-dye Laser Treatment Prior to Surgical Excision

Primary Purpose

Cicatrix

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PDL
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cicatrix focused on measuring Scar, Pulsed-dye laser, PDL

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects with ages between 18 and 65 years, who are scheduled for a dermatologic surgical excision
  • Subjects requiring surgical excisions for any condition
  • Subjects with any Fitzpatrick skin type
  • Willingness to participate in the study
  • Willingness to receive experimental treatment
  • Informed consent agreement signed by the subject
  • Willingness to follow the follow-up schedule
  • Willingness to not use any other scar treatments during the study period (i.e scar massage, over-the-counter silicone pads, intralesional steroid of 5-fluorouracil injections, laser treatments)

Exclusion Criteria:

  • Pregnancy
  • Prior scar in area to be treated
  • Known photoallergy to visible light (i.e polymorphous light eruption)
  • Subject is unable to comply with treatment or follow-up visits
  • Subject with a history of being on photosensitive medications for the past 3 months (thiazides [used to treat high blood pressure], tetracyclines, fluoroquinolones griseofulvin or sulfonamides [used to treat infections], sulfonylureas [used to treat diabetes], calcium channel blockers [used to treat hypertension], phenothiazines [used to treat serious emotional problems]).
  • Known autoimmune disease (some autoimmune diseases can lead to sensitivity to light, such as lupus erythematosus)
  • Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PDL

Arm Description

Pre-treatment of surgical area with PDL

Outcomes

Primary Outcome Measures

Scar appearance

Secondary Outcome Measures

Full Information

First Posted
May 28, 2015
Last Updated
April 18, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02458976
Brief Title
Pulsed-dye Laser Treatment Prior to Surgical Excision
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This prospective pilot study will investigate whether use of a pulsed dye laser (PDL) prior to surgical excision can improve the appearance and symptoms of scars. The primary outcome measurement for the study is the quality of the scar in areas pre-treated with PDL vs. control (cryogen spray only). For this study, subjects who are scheduled for a dermatologic surgical excision will have half of the surgical area pre-treated with PDL and the other half pre-treated with cryogen spray.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix
Keywords
Scar, Pulsed-dye laser, PDL

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PDL
Arm Type
Experimental
Arm Description
Pre-treatment of surgical area with PDL
Intervention Type
Device
Intervention Name(s)
PDL
Primary Outcome Measure Information:
Title
Scar appearance
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects with ages between 18 and 65 years, who are scheduled for a dermatologic surgical excision Subjects requiring surgical excisions for any condition Subjects with any Fitzpatrick skin type Willingness to participate in the study Willingness to receive experimental treatment Informed consent agreement signed by the subject Willingness to follow the follow-up schedule Willingness to not use any other scar treatments during the study period (i.e scar massage, over-the-counter silicone pads, intralesional steroid of 5-fluorouracil injections, laser treatments) Exclusion Criteria: Pregnancy Prior scar in area to be treated Known photoallergy to visible light (i.e polymorphous light eruption) Subject is unable to comply with treatment or follow-up visits Subject with a history of being on photosensitive medications for the past 3 months (thiazides [used to treat high blood pressure], tetracyclines, fluoroquinolones griseofulvin or sulfonamides [used to treat infections], sulfonylureas [used to treat diabetes], calcium channel blockers [used to treat hypertension], phenothiazines [used to treat serious emotional problems]). Known autoimmune disease (some autoimmune diseases can lead to sensitivity to light, such as lupus erythematosus) Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kachiu Lee, MD
Phone
617-371-4711
Email
klee52@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Beverly Dammin
Phone
617-726-3308
Email
bdammin@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R R Anderson, MD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kachiu Lee, MD
Phone
617-371-4711
Email
klee52@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Beverly Dammin
Phone
617-726-3308
Email
bdammin@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Richard R Anderson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pulsed-dye Laser Treatment Prior to Surgical Excision

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