NCT03024060

Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp

A RANDOMIZED, VEHICLE-CONTROLLED PHASE 3 STUDY TO PROVE THE SAFETY AND EFFICACY OF LEVULAN KERASTICK (AMINOLEVULINIC ACID HCl) FOR TOPICAL SOLUTION, 20% AND 10 J/CM2 OF BLUE LIGHT DELIVERED AT 10 MW/CM2 OR 20 MW/CM2 BY A NEW LIGHT SOURCE FOR THE TREATMENT OF ACTINIC KERATOSES ON THE FACE OR SCALP

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: DUSA Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	ALA	20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
DRUG	Vehicle	Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
DEVICE	IBL 20 mW	10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
DEVICE	IBL 10 mW	10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-09-01
• Completion: 2018-01-01
• First posted: 2017-01-18
• Last updated: 2017-11-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study