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Tolerability of 532 nm Laser Treatment of Port Wine Stains

Primary Purpose

Port-Wine Stain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
532 nm laser treatment
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Port-Wine Stain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: .Subject must be able to read, understand and sign the Informed Consent Form. 2. Female or Male, 18 to 75 years of age (inclusive). 3. Fitzpatrick Skin Type I - VI. 4. Have non-facial port wine stain covering at least 30cm2 area on the body. 5. Must be willing to have Lutronic DermaV treatments (532 nm) and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions. 6. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period. 7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and/or marketing), publications, and any additional marketing purposes. 8. Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treated areas during the study and has no intention of having such procedures performed during the course of the study. 9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study., Exclusion Criteria: Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 months prior to enrollment or during the study. Any type of prior cosmetic or port wine stain treatment to the target area within 3 months of study participation. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion). Pregnant and/or breastfeeding, or planning to become pregnant. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication. Hypersensitivity to light exposure. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising. Has a history of squamous cell carcinoma or melanoma in the treatment area. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen. History of pigmentary disorders, particularly tendency for hyper- or hypo- pigmentation, or any that are considered not acceptable by the study investigator. Excessively tanned or active sun tan in area to be treated, or unable/unlikely to refrain from tanning during the study. Excessive hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.

Sites / Locations

  • Wellman Center for Photomedicine, Harvard Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Port wine stain

Arm Description

The port wine stain will be treated with the DermaV laser. Within the single port wine stain, one area will be treated with standard settings (single pulse high fluence). Four other areas will be treated with multi-pulse low fluence settings. A sixth area will be an untreated control.

Outcomes

Primary Outcome Measures

Degree of improvement
For each treatment area within the port wine stain, a blinded investigator will assess improvement (0 - 25%, 26 - 50%, 51 - 75%, 76 - 100%)

Secondary Outcome Measures

Subject satisfaction
For each treatment area within the port wine stain, subject will assess satisfaction on a 1-4 scale
Side effects
subject and treating physician will assess side effects of treatment including pain, swelling, skin discoloration, scar

Full Information

First Posted
April 23, 2023
Last Updated
May 19, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05841628
Brief Title
Tolerability of 532 nm Laser Treatment of Port Wine Stains
Official Title
Tolerability of 532 nm Laser Treatment of Port Wine Stains
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to learn about treatment of port wine birthmarks treated with an FDA-approved 532 nm laser. The main questions it aims to answer are: How well are the treatments tolerated? Are there differences in tolerability of the treatment when a single high fluence laser pulse is used (the standard treatment) versus using multiple low fluence pulses? Are there differences in results when using a single high fluence pulse versus multiple low fluence pulses? type of study: Clinical Trial Participants will undergo 3 monthly laser treatments with the 532 nm DermaV laser. Part of their birthmark will be treated with the standard single-pulse high fluence approach, and other parts will be treated with the multiple-pulse low fluence approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port-Wine Stain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Port wine stain
Arm Type
Experimental
Arm Description
The port wine stain will be treated with the DermaV laser. Within the single port wine stain, one area will be treated with standard settings (single pulse high fluence). Four other areas will be treated with multi-pulse low fluence settings. A sixth area will be an untreated control.
Intervention Type
Device
Intervention Name(s)
532 nm laser treatment
Intervention Description
The port wine birthmark will be treated with the DermaV 532 nm laser.
Primary Outcome Measure Information:
Title
Degree of improvement
Description
For each treatment area within the port wine stain, a blinded investigator will assess improvement (0 - 25%, 26 - 50%, 51 - 75%, 76 - 100%)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Subject satisfaction
Description
For each treatment area within the port wine stain, subject will assess satisfaction on a 1-4 scale
Time Frame
6 months
Title
Side effects
Description
subject and treating physician will assess side effects of treatment including pain, swelling, skin discoloration, scar
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: .Subject must be able to read, understand and sign the Informed Consent Form. 2. Female or Male, 18 to 75 years of age (inclusive). 3. Fitzpatrick Skin Type I - VI. 4. Have non-facial port wine stain covering at least 30cm2 area on the body. 5. Must be willing to have Lutronic DermaV treatments (532 nm) and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions. 6. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period. 7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and/or marketing), publications, and any additional marketing purposes. 8. Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treated areas during the study and has no intention of having such procedures performed during the course of the study. 9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study., Exclusion Criteria: Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 months prior to enrollment or during the study. Any type of prior cosmetic or port wine stain treatment to the target area within 3 months of study participation. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion). Pregnant and/or breastfeeding, or planning to become pregnant. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication. Hypersensitivity to light exposure. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising. Has a history of squamous cell carcinoma or melanoma in the treatment area. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen. History of pigmentary disorders, particularly tendency for hyper- or hypo- pigmentation, or any that are considered not acceptable by the study investigator. Excessively tanned or active sun tan in area to be treated, or unable/unlikely to refrain from tanning during the study. Excessive hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cemre Turk, MD
Phone
6175133337
Email
cturk@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yakir Levin, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellman Center for Photomedicine, Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beverly Dammin
Phone
617-726-3008

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared for this pilot study.

Learn more about this trial

Tolerability of 532 nm Laser Treatment of Port Wine Stains

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