NCT02632110

Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face

A Phase 2 Study of the Effect of Microneedle Lesion Preparation, Incubation Time and Light Power Density on Photodynamic Therapy With Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% + Blue Light for the Field Treatment of Actinic Keratoses on the Face

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: DUSA Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	ALA	20% ALA applied to face prior to light treatment
DRUG	Topical Solution Vehicle	Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
DEVICE	IBL 10 mW	10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
PROCEDURE	Microneedle lesion preparation	Microneedling of all visible/palpable AK lesions prior to solution application.
DEVICE	IBL 20 mW	10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-09-12
• Completion: 2016-09-12
• First posted: 2015-12-16
• Last updated: 2018-01-18
• Results posted: 2017-12-13

Locations

8 sites across 1 country: United States