Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PDL
Pre-treatment of surgical area with PDL
  • Device: PDL

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Kachiu Lee, MD
617-371-4711
klee52@mgh.harvard.edu

More Details

Status
Unknown status
Sponsor
Massachusetts General Hospital

Study Contact

Kachiu Lee, MD
617-371-4711
klee52@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.