NCT02239679

Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: DUSA Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Aminolevulinic Acid	20% ALA applied to face for one hour prior to 10 J/cm2 blue light
DRUG	Topical Solution Vehicle	Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light
DEVICE	BLU-U	10 J/cm2 blue light delivered at 10 mW/cm2
PROCEDURE	Cryotherapy	Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2014-09-15
• Last updated: 2018-08-24
• Results posted: 2017-09-21

Locations

8 sites across 1 country: United States