Recruiting

Pulsed-Dye Laser

Sponsor:

Massachusetts General Hospital

Code:

NCT02458976

Conditions

Cicatrix

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

PDL

Study Details

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

Study ID

NCT02458976

Start date

Jun, 2015

Status verified date

Apr, 2017

Completion date

Jul, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PDL

Pre-treatment of surgical area with PDL

Interventions

PDL

Primary outcome measure

  • Scar appearance [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Kachiu Lee, MD

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

Beverly Dammin

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kachiu Lee, MD

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

Beverly Dammin

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

Principal Investigator:

Richard R Anderson, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 20, 2017

Last verified

Apr, 2017

Keywords

  • Scar
  • Pulsed-dye laser
  • PDL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2017-04-20.