Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Recruiting
Phase 3Interventional Study
Actinic Keratosis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
260 (estimated)
Sponsor
Sun Pharmaceutical Industries, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with mild to moderate actinic keratosis on their arms. Participants will receive a treatment and may have up to two sessions of light therapy.
Are You a Good Fit for This Trial?
You may be able to join if
I am a male or non-pregnant female aged 18-85 years.
I have 4-8 mild to moderate actinic keratosis lesions on one arm.
The lesions are 1 cm or smaller and at least 1 cm apart.
I am generally healthy and avoid sunbathing.
I can stop using topical products in the treatment area before visits.
If I can get pregnant, I will use effective contraception.
You may not be able to join if
I have severe actinic keratosis or untreated skin cancers.
I have an active herpes simplex infection in the treatment area.
I have a history of photosensitivity or allergies to certain substances.
I have tested positive for HIV, hepatitis B, or hepatitis C.
I have an immunosuppressed status or bleeding disorders.
I have used specific topical therapies recently on the treatment area.
I have recently taken certain systemic therapies.
I am currently pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 randomize…
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.
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Eligibility Criteria
Inclusion Criteria:
1. Patient is a male or non-pregnant female aged 18-85 years.
2. 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.
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Inclusion Criteria:
1. Patient is a male or non-pregnant female aged 18-85 years.
2. 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.
\[The treatment area should be approximately 25 cm², located on the extensor surface of only one of the upper extremities that is selected as the Index arm\]
3. Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study.
4. 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.
5. Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile.
Exclusion Criteria:
1. Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area.
2. Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year.
3. History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins.
4. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result
5. Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects.
6. 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.
7. Recent use of certain systemic therapies (e.g., corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization.
8. Recent use of hypericin or other phototoxic/photoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization.
9. Clinically significant or unstable illnesses, or history of alcohol/drug abuse in the past year.
10. Pregnancy/lactation, recent or current participation in another clinical study, or any other condition deemed unsuitable by the Investigator.
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