Treatment of Facial Actinic Keratoses With Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) or Ingenol Mebutate 0.015% Gel With and Without Prior Treatment With ALA-PDT

November 2014 | Volume 13 | Issue 11 | Original Article | 1353 | Copyright © 2014

Brian Berman MD PhD, Mark S. Nestor MD PhD, Jessica Newburger DO,
Huynhee Park DO, and Nicole Swenson DO

The Center for Clinical and Cosmetic Research, Skin and Cancer Associates, Aventura, FL

Abstract

OBJECTIVE: This randomized, 3-group study compared the efficacy and tolerability of 3 treatment modalities for facial actinic keratoses.
METHODS: Twenty-four healthy adult male and female subjects who had 4 to 8 clinically visible and discrete actinic keratoses on the face in a contiguous 25cm2 treatment area. Subjects were randomized into one of three treatment groups: 2 treatments with 5-aminolevulinic acid (ALA) and photodynamic therapy (PDT), 1 ALA-PDT treatment and 1 course of ingenol mebutate (ingenol mebutate) 0.015% gel daily for 3 consecutive days, or 1 course of ingenol mebutate gel alone. Actinic keratoses in the treatment field were counted at the baseline visit, and at the completion of the study (day 57 or day 71). At the site of application, local site reactions were graded at each visit.
RESULTS: Subjects in the two ALA-PDT treatment group had a 97.5% mean reduction (P<0.00001) from the number of baseline actinic keratosis; ALA-PDT plus ingenol mebutate gel group had an 86.7% mean reduction (P<0.00001); while subjects in the ingenol mebutate gel alone group had a 91.7% mean reduction from the number of baseline actinic keratoses. The peak composite LSR score was 4.625 for the ALA-PDT group, 10.375 for the ALA-PDT followed by ingenol mebutate gel group, and 12.625 for the ingenol mebutate gel alone group (P=0.0004 and 0.001, respectively).
CONCLUSION: ALA-PDT, ingenol mebutate gel, and a combination of the two treatment modalities are successful topical therapies for the reduction of actinic keratoses on the face. The group of subjects receiving 2 consecutive treatments with ALA-PDT, compared to treatment with ingenol mebutate gel alone or sequentially after one course of ALA-PDT had a significantly lower mean composite LSR score and a non-significant trend for greater efficacy.

J Drugs Dermatol. 2014;13(11):1353-1356.

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INTRODUCTION

Actinic keratoses are the precursor lesion for cutaneous squamous cell carcinom, and most commonly occur in sun damaged areas on the head, neck, face, trunk, and extremities. Although rates of transformation to squamous cell carcinoma are not extremely high for individual lesions, ranging from 0.025% to 20% in some reports,1 most patients suffer from multiple lesions, thus dramatically increasing the overall risk of squamous cell carcinoma transformation, and many have symptomatic lesions, so the clear consensus is that AKs require treatment. Current topical modalities for destruction of actinic keratoses include cryotherapy, imiquimod, 5-fluorouracil, diclofenac, ingenol mebutate, and photodynamic therapy (PDT), as well as surgical destruction.2

The use of PDT with 5-aminolevulinic acid (ALA) was first described in 1990.3 The FDA approved protocol for ALA-PDT requires 14 to 18 hours of incubation before exposure to the light source, but shorter incubation periods are currently used with similar efficacy in treating actinic keratosis.4 In 2012,ingenol mebutate 0.015% gel was approved by the FDA for treatment of actinic keratoses on the face and scalp. Three consecutive daily applications are required,5 and partial AK clearance rates of 63.9% and complete AK clearance rates of 42.2% have been reported.6 The objective of this randomized, 3-group study was to compare the efficacy and tolerability of 2 courses of aminolevulinic acid (ALA) photo dynamic therapy (PDT) with one course of ALA-PDT followed by one course of ingenol mebutate 0.015% gel and ingenol mebutate 0.015% gel alone for the treatment of facial actinic keratosis.

MATERIALS AND METHODS

The study protocol, consent, and all related documents were reviewed and approved by U.S. Investigational Review Board. This was a 71-day study conducted at one study center, in which 24 healthy subjects with 4 to 8 clinically visible actinic keratoses in a discrete facial area of 25 cm2 were enrolled. Subjects were over the age of 18, gave consent, were screened, and enrolled into the study. After enrollment sub-

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