The Use of Microneedles in Photodynamic Therapy

Not Applicable

Completed

• Conditions: Actinic Keratosis
• Interventions: Device: Microneedle; Radiation: Blue light; Drug: Aminolevulinic Acid

• Registration Number: NCT01812837
• Lead Sponsor: University of California, Davis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-14
• Study First Posted: 2013-03-18
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2016-12-02
• Results First Submitted QC: 2016-12-02
• Results First Posted: 2017-01-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60 minutes incubation - no pretreatment	Blue light	-
40 minutes incubation - with pretreatment	Blue light	-
20 minutes incubation - with pretreatment	Microneedle	-
20 minutes incubation - with pretreatment	Blue light	-
40 minutes incubation - with pretreatment	Microneedle	-
60 minutes incubation - with pretreatment	Microneedle	-
60 minutes incubation - with pretreatment	Blue light	-
40 minutes incubation - with pretreatment	Aminolevulinic Acid	-
60 minutes incubation - no pretreatment	Aminolevulinic Acid	-
20 minutes incubation - with pretreatment	Aminolevulinic Acid	-
60 minutes incubation - with pretreatment	Aminolevulinic Acid	-

Primary Outcome Measures

Name	Time	Method
Actinic Keratoses Reduction Percent	one month after treatment

Trial Locations

Locations (1)

UC Davis, Dermatology; 🇺🇸 Sacramento, California, United States