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NCT Number: NCT07144345

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

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Center for Dermatology Clinical Research, Inc, Fremont, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%

Drug

Solution for topical use

Vehicle containing excipients only (VEH) without active ingredient

Other

Solution for topical use

Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E

Device

BLU-U® blue light Photodynamic Therapy (PDT) illuminator

Primary outcomes

  1. 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".

Secondary outcomes

  1. Actinic Keratosis Clearance rate (AKCR)

    Time frame: Week 12

    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.

  2. Proportion of patients achieving clearance of target lesions in the Treatment Area

    Time frame: Weeks 4, 8, 12, 20, and 24.

    Target lesions are those AK lesions that were identified at baseline and treated at baseline.

  3. Actinic Keratosis Clearance rate (AKCR)

    Time frame: Weeks 4, 8, 20, and 24

    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.

  4. 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

  5. Partial Clearance Rate (PCR); i.e., proportion of patients achieving partial clearance of AK lesions

    Time frame: Weeks 4, 8, 12, 20, and 24

    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".

  6. 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

  7. Percent change in total AK lesion area from Baseline to Weeks 8, 12, and 24.

    Time frame: Weeks 8, 12, and 24

  8. Investigator Assessment of Cosmetic Response at Weeks 12, 20, and 24.

    Time frame: 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.

  9. Patient Assessment of Cosmetic Response at Weeks 12, 20, and 24.

    Time frame: 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

  10. Patient Satisfaction Score (PSS) at Weeks 12, 20, and 24.

    Time frame: 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.

  11. Recurrence Rate at Week 24

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Head, Regulatory Affairs

CONTACT

[email protected]

9122 66455645

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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