Port-Wine StainNCT04103164
Pilot Study to Evaluate the Effect of Multiple Passes on Port Wine Stain Treatments With the Cutera Excel V™ Laser.
A study testing Cutera excel V™ Laser in people with Port-Wine Stain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Two limitations of single pulse, laser treatment of port-wine stains (PWS) are: (i) hemorrhage and purpura which may lead to post-treatment pigmentation and (ii) the necessity for repeated treatment sessions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Port-Wine Stain
- What is being tested?
- Cutera excel V™ Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be able to read, understand and sign the Informed Consent Form. Female or Male, 18 to 65 years of age (inclusive). Fitzpatrick Skin Type I - VI. Have either facial or non-facial port wine stain covering at least 50cm² area on the body.
- Must be willing to have Cutera excel V laser treatments (532 nm) with prototype EV handpiece and PWS scanner and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions.
- 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.
- 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.
- Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the face during the study and has no intention of having such procedures performed during the course of the study.
- 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.,
Who cannot join
- 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.
Show all 14Show fewer
- 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 facial area to be treated, or unable/unlikely to refrain from tanning during the study.
- Excessive facial 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Open Label, Prospective, Single-Center Pilot Study to Evaluate the Effect of Multiple Passes on Port Wine Stain Treatments With the Cutera Excel V™ Laser.
Two limitations of single pulse, laser treatment of port-wine stains (PWS) are: (i) hemorrhage and purpura which may lead to post-treatment pigmentation and (ii) the necessity for repeated treatment sessions. In contrast, multiple pulses induce summation of irreversible, thermal injury from a series of lower-peak temperature heating cycles and may therefore reduce mechanical injury while preserving the selectivity of photothermal injury. Ideally, hemorrhage could be prevented and the efficiency of vessel closure could be greater. A clinical and histological pilot study of 10 adults with either facial or non-facial PWS is therefore proposed here.
- Conditions
- Port-Wine Stain
- Being tested
- Cutera excel V™ Laser
- Medical subject headings
- Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutera excel V™ LaserDevice
The Cutera® excel V laser is manufactured by Cutera, Inc. This laser with 532 nm KTP and 1064 nm Nd:YAG wavelengths has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market the device for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue 510(k) number 022226. The 532 nm wavelength is indicated for the coagulation and hemostasis of benign vascular and cutaneous lesions in dermatology including, but not limited to, benign vascular lesions like angiomas, hemangiomas, port wine stains, venous anomalies and telangiectasia; benign pigmented lesions like nevi, lentigines, chloasma, café-au-lait; verrucae; skin tags; keratoses; plaques. The Cutera® excel V laser has also obtained the European CE Mark. The system was tested to ensure compliance with federal laser performance standards as applicable.
| Study group | Role | What they receive |
|---|---|---|
| Cutera® excel V laser arm | Experimental | After the PWS is be divided into five equal portions, four of those portions treated once with a different laser fluence using the multiple-pass approach (2 J/cm² vs 4 J/cm² vs 6 J/cm² vs 8 J/cm²), and one of the portions treated with single-pass approach at 8 J/cm² Receives: Device: Cutera excel V™ Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Fluence based on efficacy and safety measurements using photographs
Find the optimal fluence in a multiple split port wine stain treatment, with 2 J/cm2 (low fluence control) vs 4 J/cm2 vs 6 J/cm2 vs 8 J/cm2 in the multiple-pass approach, compare it to our standard single-pass approach at 8 J/cm2.
-The efficacy of treatment assessed by improvement in PWS among the 5 treated areas using before and after digital photographic assessment. Each digital photographic image will include a color card, so that changes can be compared from day 0 to final visit.
The hypothesis is that the effect of multiple passes on Port Wine Stain treatments with the Cutera excel V™ Laser would be more effective than the current single pass treatment.
Measured: 6 months
Secondary outcomes (1)
Optimal Fluence based on efficacy and safety measurements using questionnaires/surveys.
- Safety will be assessed by questionnaires/surveys about frequency and severity of post treatment side-effects among the 5 treated areas after one treatment throughout the study, such as using the Visual Analog Score for Pain.
The hypothesis is that the effect of multiple passes on Port Wine Stain treatments with the Cutera excel V™ Laser would be more safe than the current single pass treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start15 Jan 2020 (estimated)
- Primary completion15 Jul 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Why it stopped: The laser is currently being worked on
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Port-Wine StainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
- Investigators
- Rox Anderson, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103164
- Sponsor's protocol ID
- 2018P000366
- Status last verified
- Oct 2019
- First submitted
- 23 May 2018
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reddy KK, Brauer JA, Idriss MH, Anolik R, Bernstein L, Brightman L, Hale E, Karen J, Weiss E, Elston D, Geronemus RG. Treatment of port-wine stains with a short pulse width 532-nm Nd:YAG laser. J Drugs Dermatol. 2013 Jan;12(1):66-71.
PubMed 23377330Jacobs AH, Walton RG. The incidence of birthmarks in the neonate. Pediatrics. 1976 Aug;58(2):218-22.
PubMed 951136
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Prospective, Single-Center Pilot Study to Evaluate the Effect of Multiple Passes on Port Wine Stain Treatments With the Cutera Excel V™ Laser.
- ClinicalTrials.gov ID
- NCT04103164
- Acronym / sponsor ID
- 2018P000366
- Conditions
- Port-Wine Stain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The laser is currently being worked on
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Jan 2020 (estimated)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two limitations of single pulse, laser treatment of port-wine stains (PWS) are: (i) hemorrhage and purpura which may lead to post-treatment pigmentation and (ii) the necessity for repeated treatment sessions. In contrast, multiple pulses induce summation of irreversible, thermal injury from a series of lower-peak temperature heating cycles and may therefore reduce mechanical injury while preserving the selectivity of photothermal injury. Ideally, hemorrhage could be prevented and the efficiency of vessel closure could be greater. A clinical and histological pilot study of 10 adults with either facial or non-facial PWS is therefore proposed here.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cutera® excel V laser arm | Experimental | Device: Cutera excel V™ LaserAfter the PWS is be divided into five equal portions, four of those portions treated once with a different laser fluence using the multiple-pass approach (2 J/cm² vs 4 J/cm² vs 6 J/cm² vs 8 J/cm²), and one of the portions treated with single-pass approach at 8 J/cm² |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be able to read, understand and sign the Informed Consent Form. Female or Male, 18 to 65 years of age (inclusive). Fitzpatrick Skin Type I - VI. Have either facial or non-facial port wine stain covering at least 50cm² area on the body.
- Must be willing to have Cutera excel V laser treatments (532 nm) with prototype EV handpiece and PWS scanner and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions.
- 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.
- 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.
- Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the face during the study and has no intention of having such procedures performed during the course of the study.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutera excel V™ LaserThe Cutera® excel V laser is manufactured by Cutera, Inc. This laser with 532 nm KTP and 1064 nm Nd:YAG wavelengths has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market the device for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue 510(k) number 022226. The 532 nm wavelength is indicated for the coagulation and hemostasis of benign vascular and cutaneous lesions in dermatology including, but not limited to, benign vascular lesions like angiomas, hemangiomas, port wine stains, venous anomalies and telangiectasia; benign pigmented lesions like nevi, lentigines, chloasma, café-au-lait; verrucae; skin tags; keratoses; plaques. The Cutera® excel V laser has also obtained the European CE Mark. The system was tested to ensure compliance with federal laser performance standards as applicable. | Device | Cutera® excel V laser arm |
Primary outcome
Optimal Fluence based on efficacy and safety measurements using photographs
Time frame: 6 months
Find the optimal fluence in a multiple split port wine stain treatment, with 2 J/cm2 (low fluence control) vs 4 J/cm2 vs 6 J/cm2 vs 8 J/cm2 in the multiple-pass approach, compare it to our standard single-pass approach at 8 J/cm2. -The efficacy of treatment assessed by improvement in PWS among the 5 treated areas using before and after digital photographic assessment. Each digital photographic image will include a color card, so that changes can be compared from day 0 to final visit. The hypothesis is that the effect of multiple passes on Port Wine Stain treatments with the Cutera excel V™ Laser would be more effective than the current single pass treatment.
1 secondary outcome
Optimal Fluence based on efficacy and safety measurements using questionnaires/surveys.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Background: PubMed 23377330Reddy KK, Brauer JA, Idriss MH, Anolik R, Bernstein L, Brightman L, Hale E, Karen J, Weiss E, Elston D, Geronemus RG. Treatment of port-wine stains with a short pulse width 532-nm Nd:YAG laser. J Drugs Dermatol. 2013 Jan;12(1):66-71.
- Background: PubMed 951136Jacobs AH, Walton RG. The incidence of birthmarks in the neonate. Pediatrics. 1976 Aug;58(2):218-22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rox Anderson, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutera excel V™ Laser in people with Port-Wine Stain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal Fluence based on efficacy and safety measurements using photographs (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04103164, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.