Recruiting

Phase 1

Levulan Kerastick with PDTAn Open-Label Pharmacokinetic Study for Patients With Actinic Keratosis on the Upper Extremities or the Face

Sponsor:

Sun Pharmaceutical Industries Limited

Code:

NCT07729579

Conditions

Actinic Keratosis (AK)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Investigational drug

Photodynamic therapy

Study Details

Brief summary:

The research study will evaluate how the body absorbs and reacts to reformulated Levulan Kerastick when applied to actinic keratosis lesions (AKs) on the skin of the forearms or face followed by photodynamic therapy (PDT), a treatment that uses application of blue light.

Conditions

Actinic Keratosis (AK)

Study ID

NCT07729579

Start date

Aug 4, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A or B

Participants will be enrolled into one of two cohorts depending on the location of the AK lesions, either the face/forehead, or the upper extremities.

Interventions

Investigational drug

The study drug will be applied to the treatment area containing an acceptable number of AK lesions.

If enrolled in group A (Cohort A), the treatment area will be on both forearms. During an incubation period of 3 hours the treatment area on both forearms will be covered. After the dressing will be removed, and the light therapy will begin and last for 8 minutes and 20 seconds.

If you are enrolled in group B (Cohort B), the treatment area will be on the face. During the incubation period of 3 hours the treatment area will not be covered. After, the light therapy will begin and last for 8 minutes and 20 seconds.

After treatment, the study staff will perform serial blood draws for PK testing at pre-determined time points during the day.

Photodynamic therapy

The study drug will be applied to the treatment area containing an acceptable number of AK lesions. If enrolled in group A (Cohort A), the treatment area will be on both forearms. During an incubation period of 3 hours the treatment area on both forearms will be covered. After the dressing will be removed, and the light therapy will begin and last for 8 minutes and 20 seconds. If you are enrolled in group B (Cohort B), the treatment area will be on the face. During the incubation period of 3 hours the treatment area will not be covered. After, the light therapy will begin and last for 8 minutes and 20 seconds. After treatment, the study staff will perform serial blood draws for PK testing at pre-determined time points during the day.

Primary outcome measure

Plasma concentrations [ Time Frame: From treatment to 48 hours ]

Central Contacts and Locations

Locations

J&S Studies

Recruiting

College Station, Texas, United States, 77845

Contacts

Brent Clary

979-774-5933 bclary@js-studies.com

More Information

Sponsor

Sun Pharmaceutical Industries Limited

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sun Pharmaceutical Industries Limited on 2026-08-13.