Boston, Massachusetts 02114


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.


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


NCT ID:

NCT02458976


Primary Contact:

Principal Investigator
R R Anderson, MD
MGH

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


Backup Contact:

Email: bdammin@mgh.harvard.edu
Beverly Dammin
Phone: 617-726-3308


Location Contact:

Boston, Massachusetts 02114
United States

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

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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