Pulsed-dye Laser Treatment Prior to Surgical Excision

Not Applicable

• Conditions: Cicatrix
• Interventions: Device: PDL

• Registration Number: NCT02458976
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-28
• Study Start: 2015-06
• Study First Posted: 2015-06-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20
• Primary Completion: 2018-06
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDL	PDL	Pre-treatment of surgical area with PDL

Primary Outcome Measures

Name	Time	Method
Scar appearance	1 month

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States