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Can a reformulated gel plus light therapy better tackle precancerous skin spots?

NCT ID NCT07729579

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This trial is testing a reformulated version of a topical drug called Levulan Kerastick, which is applied to actinic keratosis (AK) lesions on the face or forearms. After the drug sits on the skin for a few hours, it is activated by blue light in a process called photodynamic therapy (PDT). The study aims to measure how much of the drug enters the bloodstream and to check for any side effects in people with multiple AK spots.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a reformulated topical solution of aminolevulinic acid hydrochloride (ALA HCl) 20%, applied as Levulan Kerastick followed by blue light photodynamic therapy
What this could lead to
If successful, this could lead to a more effective and convenient treatment for actinic keratosis, a common precancerous skin condition.
What could go wrong
This is an early phase 1 study with only 48 participants, so it is primarily checking safety and how the drug moves through the body, not yet whether it works better than existing treatments. Side effects from the drug or light therapy are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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 85 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: * Provided written Informed Consent. * Patient is willing and able to comply with study protocol, visit schedule, and other study-related instructions/procedures, including in-clinic stay as required. * Patient is a male or non-pregnant female 18 to 85 years of age (inclusive) at Screening. * Patient has either 4 or more AK lesions on the upper extremities; or 6 or more AK lesions on the face. Lesions must be within an area of 25 cm2. * Patient is in good general health and free of any disease state or physical condition. * Patient has veins suitable for repeat blood draws. * Patient is willing to abstain from sunbathing, solarium use, exposure to artificial tanning devices. * Patient is willing to follow a consistent skin care routine without significant change. * Patient is willing to stop using all topical products within the Treatment Area(s) starting from 8 hours prior to initiation of treatment. * Patients who are women of childbearing potential must agree to use a highly effective method of contraception during the study. * Patients who are male with female partners of childbearing potential must use a barrier method of contraception (e.g., condom) if not surgically sterile. * Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test before initiation of treatment at Baseline. Exclusion Criteria: * Patient is pregnant, lactating, or is planning to become pregnant during the study. * Patient has severe AK lesions within the Treatment Area. * Patient has untreated skin cancers or lesions suspicious for skin cancer within the Treatment Area. * Patient has an active herpes simplex infection OR a history of ≥2 outbreaks within past 12 months in the Treatment Area. * Patient has significant skin abnormality involving the Treatment Area * Patient has a history of skin sensitivity to light. * Patient has known hypersensitivity to one or more components of the IP. * Patient has a history of lead poisoning or a history of significant exposure to lead. * Patient smokes more than 10 cigarettes/day. * Patient has a suppressed immune system. * Patient has a coagulation defects. * Patient has a Body Mass Index (BMI) \> 32.0 kg/m2. * Patient has donate blood recently. * Patient is positive for HIV, Hepatitis B and/or Hepatitis C. * Patient has history of alcohol or drug abuse during the past year prior. * Patient has a positive urine screen for drugs of abuse. * Patient has abnormal labs at Screening. * Patient had a major surgery within 30 days or plans to have surgery during the study. * Patient has any condition which would make it unsafe for the patient to participate in this research study or interferes with assessment/interpretation of study outcomes. * Patient received any topical or systemic therapies on the Treatment Area within a certain amount of time. * Patient is currently enrolled in an investigational drug, investigational biologic, or investigational device study. * Patient has received an investigational drug, investigational biologic, or investigational device treatment within 30 days or 5 half-lives of the experimental agent, whichever is longer, prior to initiation of treatment at Baseline.

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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

    1 site. 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

  • J&S Studies

    RECRUITING

    College Station, Texas, 77845, United States

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