Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Recruiting
Phase 3
Interventional 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.
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
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About This Trial
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…
Trial Locations
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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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