Clinical trial · Interventional
Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
A Phase II Study of Photodynamic Therapy (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities
NCT01458587CI-TRIAL-00009722completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Keratosis, Actinic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic Acid PDT (ALA) | Drug | — | UNRESOLVED |
| Vehicle PDT (VEH) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ALA
- interventionNames
- Drug: Aminolevulinic Acid PDT (ALA)
- type
- PLACEBO_COMPARATOR
- label
- Vehicle
- interventionNames
- Drug: Vehicle PDT (VEH)
Primary outcomes (1)
- measure
- Lesion Clearance Rate
- timeFrame
- Week 12
- description
- Clearance rate for all lesions
Secondary outcomes (38)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 4 Grade 1/2 AKs on each upper extremity Exclusion Criteria: * Pregnancy * 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 extremities 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, retinol, within 4 weeks of initiation of treatment. * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment. * Two or more ALA PDT treatments in the past 6 months * use of systemic retinoid therapy within 6 months of initiation of treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.