Pulsed-dye Laser Treatment Prior to Surgical Excision

NCT ID: NCT02458976

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-07-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PDL

Pre-treatment of surgical area with PDL

Group Type: EXPERIMENTAL

PDL

Intervention Type: DEVICE

Interventions

PDL

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Richard Rox Anderson, MD

Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

R R Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kachiu Lee, MD

Role: CONTACT

klee52@mgh.harvard.edu

617-371-4711

Beverly Dammin

Role: CONTACT

bdammin@mgh.harvard.edu

617-726-3308

Facility Contacts

Kachiu Lee, MD

Role: primary

klee52@mgh.harvard.edu

617-371-4711

Beverly Dammin

Role: backup

bdammin@mgh.harvard.edu

617-726-3308

Other Identifiers

2015P000196

Identifier Type: -

Identifier Source: org_study_id