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Study of Levulan Kerastick for Actinic Keratosis on Forearms or Face

This study is looking at how your body absorbs and uses Levulan Kerastick when it's applied to actinic keratosis (AK) lesions on your forearms or face. After applying the Levulan Kerastick, you will receive photodynamic therapy (PDT), which uses blue light. Researchers will measure the levels of the active ingredient (aminolaevulinic acid, ALA) and its byproduct (protoporphyrin IX, PpIX) in your blood. This helps them understand how the drug works in your body. You may be able to join if you are 18 to 85 years old and have AK lesions. The study aims to understand the drug's levels in the blood over 48 hours. The current status of this study is unclear, and it plans to enroll 48 participants.

Study design
This is an open-label study, meaning you and the researchers will know what treatment you are receiving. It plans to enroll 48 participants.
What's involved
You will need to provide written consent and be able to follow study instructions, including required in-clinic stays. Blood samples will be collected frequently over three days to measure drug levels.
Compensation
Not stated in the trial record.
Follow-up
Blood levels will be measured from the time of treatment up to 48 hours later.

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NCT07729579

An Open-Label, Two-Cohort, Pharmacokinetic Study in a Maximal Use Setting for Patients With Actinic Keratosis on the Upper Extremities or the Face

Recruiting
PHASE1Ages 18–85InterventionalTreatment
Sun Pharmaceutical Industries Limited
~48 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Investigational drugPhotodynamic therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Plasma concentrations
Measured over From treatment to 48 hours

Conditions

Actinic Keratosis (AK)

Explore related trials

Actinic Keratosis

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Brent Clary
[email protected]
979-774-5933
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Plasma concentrationsFrom treatment to 48 hours

    To evaluate the potential systemic exposure of ALA and protoporphyrin IX (PpIX) when reformulated Levulan Kerastick containing ALA HCl for topical solution, 20% is applied topically in a maximal use setting in separate cohorts of patients with actinic keratoses (AKs) involving the upper extremities or the face.