Pulsed-dye Laser Treatment Prior to Surgical Excision

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02458976

Enrollment

Registered

2015-06-01

Start date

2015-06-30

Completion date

2018-07-31

Last updated

2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cicatrix

Keywords

Scar, Pulsed-dye laser, PDL

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.

Interventions

DEVICEPDL

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Scar appearance	1 month

Countries

United States

Contacts

Primary ContactKachiu Lee, MD

klee52@mgh.harvard.edu617-371-4711

Backup ContactBeverly Dammin

bdammin@mgh.harvard.edu617-726-3308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026