Improvement of Actinic Keratoses Using Topical DNA Repair Enzymes: A Randomized Placebo-Controlled Trial

October 2017 | Volume 16 | Issue 10 | Original Article | 1030 | Copyright © 2017

Marie Stoddard BS,a Jennifer Herrmann MD,b,c,d Lauren Moy MD,eand Ronald Moy MDb,c

aDavid Geffen School of Medicine at UCLA, Los Angeles, CA bMoy-Fincher-Chipps Facial Plastics/Dermatology, Beverly Hills, CA cDepartment of Dermatology Keck School of Medicine at USC, Los Angeles, CA dDepartment of Dermatology Harbor-UCLA Medical Center, Los Angeles, CA eAlbany Medical Center, Albany, NY

Abstract

Background: Actinic keratoses (AKs) are proliferations of abnormal keratinocytes, which may progress into non-melanoma skin cancers. Although multiple treatment modalities exist for AKs, their incidence continues to rise, making new methods of both prevention and treatment necessary. DNA repair enzymes have been shown to reverse sun-damage, resulting in reduced rates of AKs and non-melanoma skin cancer (NMSC) in specific patient populations. Objective: We investigated the efficacy of a topical DNA repair enzyme lotion as a field therapy for AKs. Methods: In a single center, randomized double-blind study, we randomly assigned 15 patients with AKs on their face or scalp to receive topical DNA repair enzyme lotion or placebo (Eucerin Professional lotion). Lotion was self-applied to a treatment field twice daily for 8 consecutive weeks. Complete clearance (primary outcome) was assessed at week 8, and local reactions were quantitatively measured. Follow-up at week 12 assessed for continued clearance of AKs. Results: Thirteen subjects completed the trial. Compared to baseline, patients who used the repair enzyme had significantly fewer AKs than those using the control lotion after 8-weeks treatment. Specifically, there was a 46.6% percent decrease in AKs the DNA repair enzyme lotion group compared to a 32.7% decrease in the placebo group. Significance between the two groups was noted at the12 week follow-up, where there was an additional 29.2% decrease in AK percentage in the DNA repair enzyme group, while the placebo group had a 31.4% increase in AKs (P=0.0026). On final self-assessment, 85% of subjects reported being at least “satisfied” with the ability of the medication to decrease their AK burden. No side effects were reported. Conclusion: These results suggest that topical DNA repair enzymes may help reduce the number of AKs in individuals with moderate-to-severe photodamaged skin. Additionally, there may be a lasting effect of the DNA repair if application is discontinued. Further, cutaneous malignancies were not detected in any of the subjects during the study period. Despite the brevity of the study, these preliminary results suggest the role of DNA repair enzymes for not only treatment, but also skin cancer prevention. Further study and more objective evaluation measures are required for definitive conclusions to be drawn.

J Drugs Dermatol. 2017;16(10):1030-1034.

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INTRODUCTION

Actinic keratoses (AKs) are common, early-stage proliferations of abnormal keratinocytes, which may progress into NMSCs, particularly squamous cell carcinomas (SCC). SCC is the second leading cause of skin cancer deaths in the United States, with 60-65% of SCCs arising from previous AKs, and 40% of SCCs developing from clinically normal-appearing skin within the previous year.1, 2 Per year, the risk of AK to SCC progression has been calculated at 0.025%-16%,1,3 while the lifetime risk of malignant transformation for an AK patient is between 6.1-10.2%.4Currently, the most common form of AK therapy for discrete lesions is cryosurgery, which has been shown to effectively cure 98.8% of lesions for 1-8.5 years.5 However, this therapy is accompanied by side effects, including pain, blistering, hypopigmentation, hyperpigmentation, scarring, and infection.6 When lesions are less defined and more confluent in nature, FDA-approved field-directed therapies provide an alternative. Topical 5- Fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, as well as photodynamic therapy (PDT) with topical aminolevulinic acid can all effectively reduce numbers of pre-malignant AKs, but recurrence rates may be significant, ranging from 16% to 60%.6-10 Further, side effects, including pain, pruritus, burning, and dermatitis, make it challenging for some patients to complete therapy.6 There is a need for alternative forms of topical therapy that effectively treat AKs, but with fewer side effects.The objective of this study is to determine if DNA repair enzyme lotion, which is a combination of T4 endonuclease (T4E), photolyase, and 8-oxoguanine glycosylase, is an effective treatment

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