Trials Sponsors Conditions Drugs Pricing

Conditions

Port-Wine Stain

Outcome Measures

Primary Outcomes (1)

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%)
6 months

Secondary Outcomes (2)

Subject satisfaction
6 months
Side effects
6 months

Study Arms (1)

Port wine stain

EXPERIMENTAL

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.

Device: 532 nm laser treatment

Interventions

532 nm laser treatmentDevice

The port wine birthmark will be treated with the DermaV 532 nm laser.

Port wine stain

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Massachusetts General Hospital
Otherlead

Study Sites (1)

Wellman Center for Photomedicine, Harvard Medical School

Boston, Massachusetts, 02114, United States

RECRUITING

Beverly DamminCONTACT617-726-3008

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Yakir Levin, MD, PhD
Massachusetts General Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Cemre Turk, MD

CONTACT

6175133337 cturk@mgh.harvard.edu

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Instructor, Harvard Medical School

Study Record Dates

First Submitted

April 23, 2023

First Posted

May 3, 2023

Study Start

May 1, 2023

Actual (reported)

Primary Completion

December 2026

Estimated

You may not qualify if:

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.
+2 more criteria

Tolerability of 532 nm Laser Treatment of Port Wine Stains

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Port wine stain

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Port wine stain

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations