Phase 3
N=269
Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT02137785 ↗Enrolled (actual)
269
Serious AEs
2.6%
Results posted
Sep 2015
Primary outcome: Primary: Complete Clearance Rate — 42; 17 participants — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aminolevulinic Acid (ALA) (Drug); Topical Solution Vehicle (Drug); Blue Light Photodynamic Therapy Illuminator (BLU-U) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- DUSA Pharmaceuticals, Inc.
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Clearance Rate |
35; 12 | 0.0001 sig |
| SECONDARY AK Clearance Rate |
53.4; 26.3 | <0.0001 sig |
| SECONDARY AK Clearance Rate |
53.4; 26.3 | <0.0001 sig |
| SECONDARY Complete Clearance Rate |
35; 12 | 0.0001 sig |
| SECONDARY Subject Satisfaction Score |
71; 29; 47; 26; 12; 28 | — |
Summary
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratoses on the upper arms and hands
Eligibility Criteria
Inclusion Criteria
- Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity
Exclusion Criteria
- Pregnancy
- grade 3 and/or atypical >1cm AKs within Treatment Area
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- Subject is immunosuppressed
- unsuccessful outcome from previous ALA-PDT therapy
- currently enrolled in an investigational drug or device study
- has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
- known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
- use of the following topical preparations on the extremity to be treated:
- Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
- Cryotherapy within 2 weeks of initiation of treatment
- Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.
- Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
- use of systemic retinoid therapy within 6 months of initiation of treatment.
Data sourced from ClinicalTrials.gov (NCT02137785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.