Actinic KeratosisPhase 3NCT07144852
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
A Phase 3 study testing Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% and Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E. in people with Actinic Keratosis, run by Sun Pharmaceutical Industries, Inc. at 22 sites in United States.
Trial summary
This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the upper extremities. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% and Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 22 sitesUnited States
- Study dates
- 29 Nov 2025to Apr 2027
- Phase
- Phase 3
- 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
- Patient is a male or non-pregnant female aged 18-85 years.
- Patient must have 4-8 mild to moderate actinic keratosis (AK) lesions (Olsen grade 1 or 2) in a single treatment area on their Index arm, each measuring up to 1 cm in diameter and spaced at least 1 cm apart.
- [The treatment area should be approximately 25 cm², located on the extensor surface of only one of the upper extremities that is selected as the Index arm]
- Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study.
- Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an efficacy evaluation.
- Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile.
Who cannot join
- Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area.
- Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year.
- History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins.
- Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result
- Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects.
- Use of specific topical therapies (e.g., retinoids, steroids, cryotherapy, PDT, chemical peels) on the treatment area within 2 days to 8 weeks prior to randomization.
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- Recent use of certain systemic therapies (e.g., corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization.
- Recent use of hypericin or other phototoxic/photoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization.
- Clinically significant or unstable illnesses, or history of alcohol/drug abuse in the past year.
- Pregnancy/lactation, recent or current participation in another clinical study, or any other condition deemed unsuitable by the Investigator.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
Palmetto Clinical Trial Services, LLC
Anderson, South Carolina, 29621
- Recruiting
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
- Recruiting
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704
- Recruiting
Dermatology of Seattle & Bellevue
Burien, Washington, 98168
- Recruiting
Clarity Dermatology, PLLC
Castle Rock, Colorado, 80109
- Recruiting
Dermatologic Surgery Center of Washington
Chevy Chase, Maryland, 20815
- Recruiting
J&S Studies, Inc
College Station, Texas, 77845
- Recruiting
Center for Dermatology Clinical Research, Inc
Fremont, California, 94538
- Recruiting
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29615
- Recruiting
Onsite Clinical Solutions, LLC
Huntersville, North Carolina, 28078
- Recruiting
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37909
- Recruiting
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
- Recruiting
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
- Recruiting
Ziaderm Research LLC
North Miami Beach, Florida, 33162
- Recruiting
Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research
Pflugerville, Texas, 78660
- Recruiting
Medical Dermatology Specialist
Phoenix, Arizona, 85006
- Recruiting
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
- Recruiting
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
- Recruiting
Oregon Dermatology and Research Center
Portland, Oregon, 97210
- Recruiting
Arlington Dermatology
Rolling Meadows, Illinois, 60008
- Recruiting
Medisearch, LLC
Saint Joseph, Missouri, 64506
- Recruiting
Premier Clinical Research
Spokane, Washington, 99202
About this study
Official title: Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Upper Extremities
This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the upper extremities. Approximately 260 adult patients with 4-8 mild to moderate AK lesions on one arm will be randomized to receive either active treatment or vehicle control, followed by exposure to blue light. During the study, up to 2 PDT sessions may be administered depending on the clearance of lesions. The primary endpoint is complete clearance rate (CCR) at Week 12. Secondary endpoints include AK clearance rate (AKCR), partial clearance, change in total lesion count and area, recurrence rate, cosmetic response, and patient satisfaction. Safety assessments include adverse events, local skin reactions, vital signs, and lab tests.
- Conditions
- Actinic Keratosis
- Being tested
- Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%, Vehicle, Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.
- Keywords
- Blue Light Photodynamic Therapy, Skin Diseases, Precancerous Conditions, Photosensitizing Agents, Dermatologic Agents, Aminolevulinic Acid
- Medical subject headings
- Keratosis, Actinic, Skin Diseases, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%Drug
Solution for topical use
VehicleOther
Solution for topical use
Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.Device
BLU-U® blue light PDT illuminator
| Study group | Role | What they receive |
|---|---|---|
| Levulan | Experimental | Levulan application + incubation time (with occlusion) + blue light application Receives: Drug: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%; Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E. |
| Vehicle | Placebo comparator | Vehicle application + incubation time (with occlusion) + blue light application Receives: Other: Vehicle; Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area)
Complete clearance is defined as clearance of all AK lesions in the Treatment Area after PDT 1 or PDT 2, if re-treated; lesions should no longer be palpable nor visible to be declared as "cleared"
Measured: Week 12
Secondary outcomes (10)
Actinic Keratosis Clearance rate (AKCR)
AKCR for each patient is calculated as 100 x [1- (number of target AK lesions present at that particular visit/ number of target AK lesions present at Baseline)]. Target lesions are those AK lesions that were identified at baseline and treated at baseline
Measured: Week 4, 8 ,12, 20, and 24
Proportion of patients achieving clearance of target lesions in the Treatment Area
Target lesions are those AK lesions that were identified at baseline and treated at baseline.
Measured: Weeks 4, 8, 12, 20, and 24
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area
Measured: Weeks 4, 8, 20, and 24
Partial Clearance Rate (PCR); i.e., Proportion of patients achieving partial clearance of AK lesions)
Partial clearance is defined as clearance of at least 75% of all AK lesions in the Treatment Area; lesions should no longer be palpable nor visible to be declared as "cleared".
Measured: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion count from Baseline
Measured: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion area from Baseline
Measured: Weeks 8, 12, and 24
Investigator Assessment of Cosmetic Response
The overall cosmetic response to treatment will be assessed by a Blinded Investigator using a 4-point scale, selecting the score that best describes the patient's cosmetic outcome in actinic keratosis since treatment initiation: 1 = Excellent, 2 = Good, 3 = Fair, and 4 = Poor.
Measured: Weeks 12, 20, and 24
Patient Assessment of Cosmetic Response
The patient's overall cosmetic response to treatment will be measured by the patient on a 4-point scale, where 1 = Excellent, 2 = Good, 3 = Fair, and 4 = Poor
Measured: Weeks 12, 20, and 24
Patient Satisfaction Score (PSS) at Weeks 12, 20, and 24.
The patient's overall satisfaction with the study treatment will be assessed using a 4-point patient-reported scale, where 0 = Not satisfied at all, 1 = Slightly satisfied, 2 = Moderately satisfied, and 3 = Very satisfied.
Measured: Weeks 12, 20, and 24
Recurrence Rate at Week 24. Measured as proportion of patients presenting with at least one recurrent lesion during the follow-up period, after having achieved complete clearance at Week 12.
Measured as proportion of patients presenting with at least one recurrent lesion during the follow-up period, after having achieved complete clearance at Week 12.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start29 Nov 2025
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144852
- Sponsor's protocol ID
- LEV-24-01
- Status last verified
- Nov 2026
- First submitted
- 20 Aug 2025
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Upper Extremities
- ClinicalTrials.gov ID
- NCT07144852
- Acronym / sponsor ID
- LEV-24-01
- Conditions
- Actinic Keratosis
- Keywords
- Blue Light Photodynamic Therapy, Skin Diseases, Precancerous Conditions, Photosensitizing Agents, Dermatologic Agents, Aminolevulinic Acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Aug 2025 (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.
This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the upper extremities. Approximately 260 adult patients with 4-8 mild to moderate AK lesions on one arm will be randomized to receive either active treatment or vehicle control, followed by exposure to blue light. During the study, up to 2 PDT sessions may be administered depending on the clearance of lesions. The primary endpoint is complete clearance rate (CCR) at Week 12. Secondary endpoints include AK clearance rate (AKCR), partial clearance, change in total lesion count and area, recurrence rate, cosmetic response, and patient satisfaction. Safety assessments include adverse events, local skin reactions, vital signs, and lab tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levulan | Experimental | Drug: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%, Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.Levulan application + incubation time (with occlusion) + blue light application |
| Vehicle | Placebo comparator | Other: Vehicle, Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.Vehicle application + incubation time (with occlusion) + blue light application |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is a male or non-pregnant female aged 18-85 years.
- Patient must have 4-8 mild to moderate actinic keratosis (AK) lesions (Olsen grade 1 or 2) in a single treatment area on their Index arm, each measuring up to 1 cm in diameter and spaced at least 1 cm apart.
- [The treatment area should be approximately 25 cm², located on the extensor surface of only one of the upper extremities that is selected as the Index arm]
- Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study.
- Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an efficacy evaluation.
Key exclusion criteria (10 listed)
- Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area.
- Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year.
- History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins.
- Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result
- Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects.
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 |
|---|---|---|
| Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%Solution for topical use | Drug | Levulan |
| VehicleSolution for topical use | Other | Vehicle |
| Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.BLU-U® blue light PDT illuminator | Device | Levulan, Vehicle |
Primary outcome
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area)
Time frame: Week 12
Complete clearance is defined as clearance of all AK lesions in the Treatment Area after PDT 1 or PDT 2, if re-treated; lesions should no longer be palpable nor visible to be declared as "cleared"
10 secondary outcomes
Actinic Keratosis Clearance rate (AKCR)
Time frame: Week 4, 8 ,12, 20, and 24
Proportion of patients achieving clearance of target lesions in the Treatment Area
Time frame: Weeks 4, 8, 12, 20, and 24
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area
Time frame: Weeks 4, 8, 20, and 24
Partial Clearance Rate (PCR); i.e., Proportion of patients achieving partial clearance of AK lesions)
Time frame: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion count from Baseline
Time frame: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion area from Baseline
Time frame: Weeks 8, 12, and 24
Investigator Assessment of Cosmetic Response
Time frame: Weeks 12, 20, and 24
Patient Assessment of Cosmetic Response
Time frame: Weeks 12, 20, and 24
Patient Satisfaction Score (PSS) at Weeks 12, 20, and 24.
Time frame: Weeks 12, 20, and 24
Recurrence Rate at Week 24. Measured as proportion of patients presenting with at least one recurrent lesion during the follow-up period, after having achieved complete clearance at Week 12.
Time frame: Week 24
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 4 Nov 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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% and Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E. in people with Actinic Keratosis, run by Sun Pharmaceutical Industries, Inc. at 22 sites 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 6 inclusion and 10 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Head, Regulatory Affairs (0226645 ext. 5789, Clinical.Trial@sunpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area) (time frame: Week 12). 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 4 Nov 2026.