New light therapy could fade Port-Wine stains
NCT ID NCT05171894
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a treatment called Hemoporfin photodynamic therapy for port-wine birthmarks. It involves injecting a drug that is activated by green light to target the birthmark. 84 adults aged 18 to 75 will receive up to 3 treatment cycles to see which light dose works best and is safest.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hemoporfin (a photosensitizing drug) plus green light
- What this could lead to
- If successful, this could offer a more effective treatment for port-wine birthmarks, potentially reducing their appearance with fewer sessions.
- What could go wrong
- This is an early Phase 2 trial with only 84 participants, so results may not apply to everyone. Side effects from the drug and light are possible, and the treatment may not work for all birthmark locations.
Why investors are watching
Shanghai Fudan-Zhangjiang is testing Hemoporfin photodynamic therapy for port-wine birthmarks in a Phase 2 trial with 84 participants. The study compares different light doses against a placebo to see if the treatment clears the birthmarks safely. For a small company, this readout could define whether its lead product has a viable path to market.
If it works: A positive result could show that Hemoporfin works at a specific light dose, giving the company a clear product profile to take into later trials. That evidence could strengthen its position with partners or regulators.
If it fails: The trial could fail to show a meaningful difference from the placebo, or the light doses could cause safety problems. Trials at this stage often miss their goals, and a weak result would set the program back and raise doubts about the company's pipeline.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent. 2. Subject is Fitzpatrick skin type I-VI. 3. A male subject must agree to use contraception during the Treatment Period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period. 4. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) . OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 30 days after the last dose of study treatment. 5. The subject has a clinical diagnosis of PWB located i) on the extremities, trunk, caudal cervical and/or retroauricular area (Stage One); ii) on the face and/or neck (Stage Two). 6. The longest diameter of the treatment area is ≥3 cm, and the short diameter is ≥2 cm. 7. Subject is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 8. Subject, in the Investigator's opinion, is in good general health and free of any disease state or physical condition that may impair the evaluation of PWB or expose the subject to an unacceptable risk by study participation. 9. If the subject has a history of epilepsy or seizure, the disease must remain stable for at least 6 months prior to C1D1. Exclusion Criteria: 1. Subject is pregnant, lactating, or is planning to become pregnant during the study. 2. Subject has plaque/nodular changes and severe hypertrophy within the target PWB area. 3. Subject has Sturge-Weber syndrome. 4. Subject has any skin pathology or condition that, in the Investigator's opinion, could interfere with the evaluation of the study drug or requires use of interfering topical, systemic, or surgical therapy. 5. The subject has evidence of scarring within the target PWB area and/or the subject has a history of hypertrophic scarring or keloidal scarring. 6. Subject is immunosuppressed related to medication use and/or disease. 7. The subject has clinical abnormalities, as determined by the Investigator, which makes them unsuitable for receiving study treatment in the Investigator's opinion at Screening. 8. Subject has received any therapy on the treatment region that, in the Investigator's opinion, may affect the target PWB area. 9. Subject is known or in the opinion of the Investigator likely to be noncompliant with the requirements of the study protocol (eg, due to alcoholism, drug dependency, mental incapacity). 10. Subject has a history of either significant neurological events (such as major stroke) or a mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study. 11. Subject has an unstable cardiac disease or has any medical condition that in the opinion of the Investigator may worsen from receipt of study treatment or subject participation. 12. The subject has a history of cutaneous photosensitization, porphyria, or photodermatosis. 13. The subject has the need or has plans to be exposed to artificial tanning devices or excessive sunlight during the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
RECRUITINGSan Diego, California, 92121, United States
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Maryland Dermatology, Laser, Skin & Vein Institute
RECRUITINGHunt Valley, Maryland, 21030, United States
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Miami Dermatology and Laser Institute
RECRUITINGMiami, Florida, 33173, United States
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St. Luke's University Health Network
RECRUITINGBethlehem, Pennsylvania, 18015, United States
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UCI Health Beckman Laser Institute & Medical Clinic
RECRUITINGIrvine, California, 92697, United States
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