Clinical trial · Interventional
Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II
Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): data analysis unequivocal - requires study methodology re-evaluation
Summary
Brief summary (as posted)
The investigators wish to determine the time to disease progression for benign neurofibromas treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy (PDT) in patients with neurofibromatosis type 1 (NF1). The investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.
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 |
|---|---|---|---|
| NEUROFIBROMATOSIS 1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aminolevulinic acid | Drug | Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PDT Treatment
- description
- Each subject will have either placebo or Levulan Kerastick topical application applied to matched sets of neurofibromas. Each subject will have both sets, in order to serve as his/her own control subject. 16 to 24 hours post study drug treatment, both sets of neurofibromas, Levulan and placebo treated, will be irradiated with red light (630 nm) from an Omnilux Revive light device at 100 mW/cm2 for 1000 seconds (16.7 minutes).
- interventionNames
- Drug: aminolevulinic acid
Primary outcomes (1)
- measure
- Time to disease progression
- timeFrame
- 3 years
- description
- The time it takes for 50% growth in tumor size over baseline measurements.
Secondary outcomes (1)
- measure
- Tumor growth rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is 14 years or older. 2. Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis section). 3. Tumor Location: cutaneous, trunk, or limbs only. 4. Tumor Type: superficial dermal neurofibromas ≤4mm deep. 5. Patient has provided written informed consent. 6. Patient is willing to and can comply with study follow-up requirements. 7. Absence of any other malignancy. Exclusion Criteria: 1. Life expectancy less than 3 years. 2. Pregnancy. 3. Cutaneous photosensitivity to the wavelengths used to active PDT. 4. A diagnosis of porphyria. 5. Allergy to aminolevulinic acid or any of the topical solution vehicle components. 6. Previous chemotherapy within 6 weeks of proposed PDT. 7. Other concurrent tumor therapy.
References
Publications (0)
Data not yet available