N/A
Completed N=51
The Use of Microneedles in Photodynamic Therapy
Source: ClinicalTrials.gov NCT01812837 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Actinic Keratoses Reduction Percent — 71.4; 80.2; 72.5; 68.3 percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Actinic Keratoses Reduction Percent |
71.4; 80.2; 72.5; 68.3; 80.1; 73.6 | — |
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. Informational only — not medical advice.