Levulan Kerastick for Actinic Keratosis Treatment

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.
Ready to participate?

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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.

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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. \[…
Contacts

Head, Regulatory Affairs

0226645

Clinical.Trial@sunpharma.com

CONTACT