Clinical trial · Interventional
The Use of Microneedles in Photodynamic Therapy
- 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 global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses The specific aims are as follows: 1. Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc. 2. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.
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 | Drug | Aminolevulinic Acid | ALIAS |
| Blue light | Radiation | — | UNRESOLVED |
| Microneedle | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 20 minutes incubation - with pretreatment
- interventionNames
- Device: Microneedle
- Drug: Aminolevulinic Acid
- Radiation: Blue light
- type
- EXPERIMENTAL
- label
- 40 minutes incubation - with pretreatment
- interventionNames
- Device: Microneedle
- Drug: Aminolevulinic Acid
- Radiation: Blue light
- type
- EXPERIMENTAL
- label
- 60 minutes incubation - with pretreatment
- interventionNames
- Device: Microneedle
- Drug: Aminolevulinic Acid
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects who are 18 and older 2. Subjects who have at least 3 actinic keratoses on each side of the forehead 3. Subjects who signed an IRB approved informed consent Exclusion Criteria: 1. Subjects who smoke 2. Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition. 3. Subjects who received a diagnosis of skin cancer on the face in past year 4. Subjects who received field treatment for actinic keratoses to the face in the past 60 days
References
Publications (0)
Data not yet available