Actinic Keratosis (AK)Phase 1NCT07729579
An Open-Label Pharmacokinetic Study for Patients With Actinic Keratosis on the Upper Extremities or the Face
A Phase 1 study testing Investigational drug and Photodynamic therapy in people with Actinic Keratosis (AK), run by Sun Pharmaceutical Industries Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Actinic Keratosis (AK)
- What is being tested?
- Investigational drug and Photodynamic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
J&S Studies
College Station, Texas, 77845
Brent Clary, 979-774-5933, bclary@js-studies.com
About this study
Official title: An Open-Label, Single-Period, Pharmacokinetic Study of Aminolevulinic Acid (ALA) and Protoporphyrin IX (PpIX) When Reformulated Levulan Kerastick is Applied Topically in A Maximal Use Setting in Separate Cohorts of Patients With Actinic Keratosis on the Upper Extremities or Actinic Keratosis on the Face
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.
Read the detailed description
This is a pharmacokinetic (PK) study which involves measuring drug levels in blood. Blood levels of Levulan Kerastick's active ingredient (aminolaevulinic acid, ALA) and its by-product (protoporphyrin IX, PpIX) will be measured. PK blood samples will be collected at: pre-application, 15 minutes, 0.5 hours, 1 hour, 2 hours, 3 hours, 3.5 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, and 16 hours after dose on Day 1; at 24 hours and 36 hours post-dose on Day 2; and at 48 hours post-dose on Day 3.
- Conditions
- Actinic Keratosis (AK)
- Being tested
- Investigational drug, Photodynamic therapy
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational drugDrug
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 therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A or B | Experimental | 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. Receives: Drug: Investigational drug; Device: Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations
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.
Measured: From treatment to 48 hours
Secondary outcomes (1)
Safety/Tolerability
To evaluate safety/tolerability (local and systemic) of reformulated Levulan Kerastick in these cohorts.
Measured: From treatment to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start4 Aug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic Keratosis (AK)Studies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants are enrolled into one of two cohorts depending on the treatment area affected, but receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729579
- Sponsor's protocol ID
- LEVU-24-02
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Period, Pharmacokinetic Study of Aminolevulinic Acid (ALA) and Protoporphyrin IX (PpIX) When Reformulated Levulan Kerastick is Applied Topically in A Maximal Use Setting in Separate Cohorts of Patients With Actinic Keratosis on the Upper Extremities or Actinic Keratosis on the Face
- ClinicalTrials.gov ID
- NCT07729579
- Acronym / sponsor ID
- LEVU-24-02
- Conditions
- Actinic Keratosis (AK)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pharmacokinetic (PK) study which involves measuring drug levels in blood. Blood levels of Levulan Kerastick's active ingredient (aminolaevulinic acid, ALA) and its by-product (protoporphyrin IX, PpIX) will be measured. PK blood samples will be collected at: pre-application, 15 minutes, 0.5 hours, 1 hour, 2 hours, 3 hours, 3.5 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, and 16 hours after dose on Day 1; at 24 hours and 36 hours post-dose on Day 2; and at 48 hours post-dose on Day 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are enrolled into one of two cohorts depending on the treatment area affected, but receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Cohort A or B | Experimental | Drug: Investigational drug, Device: Photodynamic therapyParticipants will be enrolled into one of two cohorts depending on the location of the AK lesions, either the face/forehead, or the upper extremities. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational drugThe 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. | Drug | Cohort A or B |
| Photodynamic therapyThe 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. | Device | Cohort A or B |
Primary outcome
Plasma concentrations
Time frame: From 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.
1 secondary outcome
Safety/Tolerability
Time frame: From treatment to Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigational drug and Photodynamic therapy in people with Actinic Keratosis (AK), run by Sun Pharmaceutical Industries Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations (time frame: From treatment to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.