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New light therapy could fade Port-Wine stains

NCT ID NCT05171894

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center

    RECRUITING

    San Diego, California, 92121, United States

  • Maryland Dermatology, Laser, Skin & Vein Institute

    RECRUITING

    Hunt Valley, Maryland, 21030, United States

  • Miami Dermatology and Laser Institute

    RECRUITING

    Miami, Florida, 33173, United States

  • St. Luke's University Health Network

    RECRUITING

    Bethlehem, Pennsylvania, 18015, United States

  • UCI Health Beckman Laser Institute & Medical Clinic

    RECRUITING

    Irvine, California, 92697, United States

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