Clinical trial · Interventional
Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities
NCT02137785CI-TRIAL-00019131completedPhase 3Results 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 Photodynamic Therapy (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 |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic Acid (ALA) | Drug | Aminolevulinic Acid | ALIAS |
| Blue Light Photodynamic Therapy Illuminator (BLU-U) | Device | — | UNRESOLVED |
| Topical Solution Vehicle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ALA
- interventionNames
- Drug: Aminolevulinic Acid (ALA)
- Device: Blue Light Photodynamic Therapy Illuminator (BLU-U)
- type
- PLACEBO_COMPARATOR
- label
- Vehicle
- interventionNames
- Drug: Topical Solution Vehicle
- Device: Blue Light Photodynamic Therapy Illuminator (BLU-U)
Primary outcomes (1)
- measure
- Complete Clearance Rate
- timeFrame
- Week 12
- description
- proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDPiacquadio D, Berman B, Siegel DM, Bhatia N, Brocato J, Squittieri N, Pariser DM. Treatment Satisfaction and Acceptability of 20% Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses of the Face, Scalp, and Upper Extremities. J Clin Aesthet Dermatol. 2023 Dec;16(12):46-51. PMID 38125671