Can a reformulated gel plus light therapy better tackle precancerous skin spots?
NCT ID NCT07729579
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
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 85 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: * 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.
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The places running it
1 site. 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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J&S Studies
RECRUITINGCollege Station, Texas, 77845, United States
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- Half the time, same effect? new study tests shorter light therapy for scalp lesions
- New ointment for Sun-Damaged skin spots enters early human testing