Pulsed-dye Laser Treatment Prior to Surgical Excision

NCT02458976 | Unknown DMC

• 1 other identifier: 2015P000196
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cicatrix

Keywords

Scar; Pulsed-dye laser; PDL

Outcome Measures

Primary Outcomes (1)

• Scar appearance

  1 month

Study Arms (1)

PDL

EXPERIMENTAL

Pre-treatment of surgical area with PDL

Device: PDL

Interventions

PDL DEVICE

PDL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• R R Anderson, MD

  MGH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kachiu Lee, MD

CONTACT

617-371-4711; klee52@mgh.harvard.edu

Beverly Dammin

CONTACT

617-726-3308; bdammin@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)