Pulsed-dye Laser Treatment Prior to Surgical Excision

Mass General Brigham

Status

Unknown

Conditions

Cicatrix

Treatments

Device: PDL

Study type

Interventional

Funder types

Other

Identifiers

NCT02458976

2015P000196

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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