Pulsed-dye Laser Treatment Prior to Surgical Excision

Cicatrix Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02458976
• Other study ID #: 2015P000196
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2015
• Last updated: April 18, 2017
• Start date: June 2015
• Est. completion date: July 2018

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: Kachiu Lee, MD
• Phone: 617-371-4711
• Email: klee52[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix

Intervention

Device:
• PDL

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar appearance		1 month