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

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.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
160 (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 face or bald scalp. Approximately 160 adult patients with 4-8 mild to moderate AK lesions will be randomized into fou…
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 (either face or bald scalp, not both), each ≤1 cm in diameter and spaced at least 1 cm apart. \[…
Contacts

Head, Regulatory Affairs

9122 66455645

Clinical.Trial@sunpharma.com

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