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

NCT02239679 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2018-08-24

Study results available
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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

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.

Sponsors & Collaborators

  • DUSA Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart Marcus, MD, PhD · DUSA Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-07-31
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02239679 on ClinicalTrials.gov