Actinic KeratosisPhase 3NCT07144345

Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp

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 12 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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: 160 participants
Where: 12 sitesUnited States
Study dates: 19 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 (either face or bald scalp, not both), each ≤1 cm in diameter and spaced at least 1 cm apart. [The treatment area should be approximately 25 cm², excluding sensitive facial regions (eyes, lips, nostrils, ears, mouth)]
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

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Head, Regulatory Affairs contact

9122 66455645

Clinical.Trial@sunpharma.com

City, postcode or hospital

Sites recruiting now only

12 sites in 1 country

United States12 sites, 12 recruiting

Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Recruiting
Dermatologic Surgery Center of Washington
Chevy Chase, Maryland, 20815
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
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Recruiting
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Recruiting
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
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
Recruiting

Other trials in United States

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 Face and (Bald) Scalp

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 face or bald scalp. Approximately 160 adult patients with 4-8 mild to moderate AK lesions will be randomized into four treatment arms based on two variables: type of treatment (active drug or vehicle) and incubation time. 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 containing excipients only (VEH) without active ingredient, 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
Vehicle containing excipients only (VEH) without active ingredientOther
Solution for topical use
Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170EDevice
BLU-U® blue light Photodynamic Therapy (PDT) illuminator

Study groups in NCT07144345
Study group	Role	What they receive
Levulan + Incubation time 1	Experimental	Levulan application + Incubation time 1 + 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 + Incubation time 1	Placebo comparator	Vehicle application + Incubation time 1 + blue light application Receives: Other: Vehicle containing excipients only (VEH) without active ingredient; Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E
Levulan + Incubation time 2	Experimental	Levulan application + Incubation time 2 + 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 + Incubation time 2	Placebo comparator	Vehicle application + Incubation time 2 + blue light application Receives: Other: Vehicle containing excipients only (VEH) without active ingredient; 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 (11)

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 12
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.
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: Weeks 4, 8, 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 to Weeks 4, 8, 12, 20, and 24.
Measured: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion area from Baseline to Weeks 8, 12, and 24.
Measured: Weeks 8, 12, and 24
Investigator Assessment of Cosmetic Response at Weeks 12, 20, and 24.
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 at Weeks 12, 20, and 24.
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 1 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.

19 Nov 2025Apr 2027

First posted27 Aug 2025
Study start19 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: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07144345
Sponsor's protocol ID: LEV-21-01
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

Interested in taking part?

Head, Regulatory Affairs

9122 66455645

Clinical.Trial@sunpharma.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
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Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
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All Actinic Keratosis trials

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 Face and (Bald) Scalp
ClinicalTrials.gov ID: NCT07144345
Acronym / sponsor ID: LEV-21-01
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: 160 participants (estimated)
Lead sponsor: Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
Study start: 19 Nov 2025 (actual)
Primary completion: Jan 2027 (estimated)
Study completion: Apr 2027 (estimated)
First posted: 27 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Levulan + Incubation time 1	Experimental	Drug: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%, Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170ELevulan application + Incubation time 1 + blue light application
Vehicle + Incubation time 1	Placebo comparator	Other: Vehicle containing excipients only (VEH) without active ingredient, Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170EVehicle application + Incubation time 1 + blue light application
Levulan + Incubation time 2	Experimental	Drug: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%, Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170ELevulan application + Incubation time 2 + blue light application
Vehicle + Incubation time 2	Placebo comparator	Other: Vehicle containing excipients only (VEH) without active ingredient, Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170EVehicle application + Incubation time 2 + 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 (5 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 (either face or bald scalp, not both), each ≤1 cm in diameter and spaced at least 1 cm apart. [The treatment area should be approximately 25 cm², excluding sensitive facial regions (eyes, lips, nostrils, ears, mouth)]
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.

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 + Incubation time 1, Levulan + Incubation time 2
Vehicle containing excipients only (VEH) without active ingredientSolution for topical use	Other	Vehicle + Incubation time 1, Vehicle + Incubation time 2
Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170EBLU-U® blue light Photodynamic Therapy (PDT) illuminator	Device	Levulan + Incubation time 1, Levulan + Incubation time 2, Vehicle + Incubation time 1, Vehicle + Incubation time 2

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".

11 secondary outcomes

Actinic Keratosis Clearance rate (AKCR)
Time frame: Week 12
Proportion of patients achieving clearance of target lesions in the Treatment Area
Time frame: Weeks 4, 8, 12, 20, and 24.
Actinic Keratosis Clearance rate (AKCR)
Time frame: Weeks 4, 8, 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 to Weeks 4, 8, 12, 20, and 24.
Time frame: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion area from Baseline to Weeks 8, 12, and 24.
Time frame: Weeks 8, 12, and 24
Investigator Assessment of Cosmetic Response at Weeks 12, 20, and 24.
Time frame: Weeks 12, 20, and 24
Patient Assessment of Cosmetic Response at Weeks 12, 20, and 24.
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
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.

Related trials for Actinic Keratosis

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
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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.

Head, Regulatory Affairs contact

9122 66455645

Clinical.Trial@sunpharma.com

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 12 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 (9122 66455645, 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?

On the ClinicalTrials.gov record for NCT07144345.

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.