Clinical trial · Observational
Twelve Month Follow-Up of CP0108
Twelve Month Follow-Up Evaluation of Subjects Participating in DUSA-CP0108 (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)
NCT02209012CI-TRIAL-00024017completedClinicalTrials.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 the long-term safety and efficacy of Levulan PDT in subjects with multiple actinic keratosis of the upper extremities who received treatment as part of the DUSA CP0108 study.
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 |
| BLU-U Blue Light Photodynamic Therapy Illuminator | Device | — | UNRESOLVED |
| Topical Solution Vehicle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ALA
- description
- Subjects who received ALA in CP0108
- interventionNames
- Drug: Aminolevulinic Acid (ALA)
- Device: BLU-U Blue Light Photodynamic Therapy Illuminator
- label
- Vehicle
- description
- Subjects who received Vehicle in CP0108
- interventionNames
- Drug: Topical Solution Vehicle
- Device: BLU-U Blue Light Photodynamic Therapy Illuminator
Primary outcomes (4)
- measure
- Subject Recurrence Rate
- timeFrame
- Month 12
- description
- percentage of subjects who had achieved 100% clearance at Visit 6 (Week 12) in CP0108, that have one or more previously treated (as part of CP0108) AK lesion(s) present in the Treatment Area at any visit during CP0108A follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject must have been enrolled in the DUSA-CP0108 study, completed their assigned treatment and Visit 6 (Week 12).
References
Publications (0)
Data not yet available
No reference posted for this study.