Clinical trial · Interventional
Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis
A Pilot Study to Investigate the Use of Topical Levulan® With Vbeam® Laser for the Treatment of Actinic Keratoses
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to low accrual
Summary
Brief summary (as posted)
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using topical aminolevulinic acid may be effective against actinic keratosis. PURPOSE: This randomized clinical trial is studying how well different photodynamic therapy regimens using topical aminolevulinic acid work in treating patients with actinic keratosis.
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 |
|---|---|---|---|
| Precancerous/Nonmalignant Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aminolevulinic acid | Drug | Aminolevulinic Acid | ALIAS |
| laser therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Arm 1 - ALA
- description
- Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
- interventionNames
- Drug: aminolevulinic acid
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT
- interventionNames
- Drug: aminolevulinic acid
- type
- EXPERIMENTAL
- label
- Arm 3
- description
- Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Actinic keratosis lesion located in any of the following body sites:
* Stratum 1\*: face and neck, scalp, or upper torso
* At least 1 clinically evident thin actinic keratosis on each side of the midline of any of the above areas
* Stratum 2\*: arms or legs
* At least 1 clinically evident thick actinic keratosis on each arm or leg NOTE: \*One patient may be in one or both strata depending on the location of the lesion(s)
* Lesions to be treated on this protocol must not have been previously treated by other modalities for at least 2 months prior to study entry
PATIENT CHARACTERISTICS:
* No porphyria or known hypersensitivity to porphyrins
* No known photosensitivity disease
* No known sensitivity to any components of aminolevulinic acid topical solution
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
* Other concurrent topical therapies at lesion sites other than those used in this protocol are allowed
* No other concurrent photosensitizer drugsReferences
Publications (0)
Data not yet available