N/A
N=51
The Use of Microneedles in Photodynamic Therapy
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT01812837 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Actinic Keratoses Reduction Percent — 71.4; 80.2; 72.5; 68.3 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Microneedle (Device); Aminolevulinic Acid (Drug); Blue light (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Actinic Keratoses Reduction Percent |
71.4; 80.2; 72.5; 68.3; 80.1; 73.6 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects who are 18 and older
- Subjects who have at least 3 actinic keratoses on each side of the forehead
- Subjects who signed an IRB approved informed consent
Exclusion Criteria
- Subjects who smoke
- Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition.
- Subjects who received a diagnosis of skin cancer on the face in past year
- Subjects who received field treatment for actinic keratoses to the face in the past 60 days
Data sourced from ClinicalTrials.gov (NCT01812837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.