Clinical trial · Interventional
The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
NCT02594644CI-TRIAL-00035977completedN/AResults 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 aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of 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 |
|---|---|---|---|
| Keratosis, Actinic | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic Acid | Drug | Aminolevulinic Acid | ALIAS |
| Blue Light | Radiation | — | UNRESOLVED |
| Microneedle Roller | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 10-minute Incubation with Microneedle Roller & Sham
- description
- 10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
- interventionNames
- Device: Microneedle Roller
- Drug: Aminolevulinic Acid
- Radiation: Blue Light
- type
- EXPERIMENTAL
- label
- 20-minute Incubation with Microneedle Roller & Sham
- description
- 20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
- interventionNames
- Device: Microneedle Roller
- Drug: Aminolevulinic Acid
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age and older * Subjects has actinic keratoses and qualifies for photodynamic therapy * Do not meet any of the exclusion criteria Exclusion Criteria: * Subjects who smoke * Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition * Subjects who have established allergy to topical ALA * Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months
References
Publications (1)
- DERIVEDPetukhova TA, Hassoun LA, Foolad N, Barath M, Sivamani RK. Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses: A Randomized Clinical Trial. JAMA Dermatol. 2017 Jul 1;153(7):637-643. doi: 10.1001/jamadermatol.2017.0849. PMID 28514458