N/A
Completed N=32
The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
Keratosis, Actinic
Source: ClinicalTrials.gov NCT02594644 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Difference in the Percentage of Complete Clearance of the Actinic Keratoses — 43; 76; 38; 58 Percentage of AK Clearance
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in the Percentage of Complete Clearance of the Actinic Keratoses |
43; 76; 38; 58 | — |
| SECONDARY Visual Analog Pain Scale |
1.4; 1.3; .3; .3; 0.3; .5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02594644). 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.