Management of cancerization field with a medical device containing photolyase: a randomized, double‐blind, parallel‐group pilot study

Moscarella, Elvira; Argenziano, Giuseppe; Longo, Caterina; Aladren, Sonia

doi:10.1111/jdv.14209

Cited by 23 publications

(19 citation statements)

References 6 publications

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“…Their function is to recognize and remove the UV-induced DNA lesions by a mechanism called photo-reactivation [11]. A growing number of clinical and experimental studies have recently demonstrated the efficacy of photolyase-based novel approaches on cancerization field; however, most of these reports include a limited number of patients, a short follow-up period, and are not double-blind studies [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26]. Additionally, other repair enzymes such as glycosylases and endonucleases have been described and they do not need light to be activated [27,28].…”

Section: Introductionmentioning

confidence: 99%

Long-Term Efficacy of a New Medical Device Containing Fernblock® and DNA Repair Enzyme Complex in the Treatment and Prevention of Cancerization Field in Patients with Actinic Keratosis

Bustos¹,

Aguilera²,

García³

et al. 2019

J Clin Exp Dermatol Res

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subclinical and histologically abnormal epidermal tissue due to Ultraviolet (UV)-induced DNA damage. The photoproducts, "as consequence of DNA damage induced by UV", are mainly cyclobutane pyrimidine dimers (CPDs). Fernblock® demonstrated in previous studies significant reduction of the number of CPDs induced by UV radiation. Photolyases are a specific group of enzymes that remove the major UV-induced DNA lesions by a mechanism called photo-reactivation. the effect of a new medical device (NMD) containing a DNA-repair enzyme complex (photolyases, endonucleases and glycosilases), a combination of UV-filters, and Fernblock® in the treatment of the cancerization field in 30 AK patients after photodynamic therapy (PDT). Patients were randomized into two groups: patients receiving a standard sunscreen (SS) and patients receiving the NMD. Clinical, dermoscopic, reflectance confocal microscopy (RCM) and histological evaluations were performed. between them (p=0.476). A significant increase in the number of AKs was observed in SS group after six (p=0.026) and twelve months of PDT (p=0.038); however, this increase did not reach statistical significance in the NMD group. Regarding RCM evaluation, honeycomb pattern assessment after twelve months of PDT showed significant differences in the extension and grade of the atypia in the NMD group compared to SS group (p=0.030 and p=0.026, respectively). Concerning histopathological evaluation, keratinocyte atypia grade improved from baseline to six months after PDT in all the groups, with no statistically significant differences between the groups. Twelve months after PDT, p53 expression was significantly lower in the NMD group compared to SS group (p=0.028). The product was well-tolerated, with no serious adverse events reported.

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Section: Introductionmentioning

confidence: 99%

Long-Term Efficacy of a New Medical Device Containing Fernblock® and DNA Repair Enzyme Complex in the Treatment and Prevention of Cancerization Field in Patients with Actinic Keratosis

Bustos¹,

Aguilera²,

García³

et al. 2019

J Clin Exp Dermatol Res

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“…Although most of the studies are open-label, the comparators in the case of double parallel-group pilot studies [ 53 , 54 ] were sunscreen SPF 50+, the notable clinical improvement of lesions and cancerization field seen in these studies cannot be explained by sunscreen alone.…”

Section: Discussionmentioning

confidence: 99%

“…Moscarella et al evaluated the effects of a 6-month treatment with Eryfotona AK-NMSC vs sunscreen SPF50+ in a prospective, randomized, parallel, double-blind, pilot study [ 53 ]. Fifty patients with at least four AK lesions at the same anatomical photo-exposed area were enrolled and 36 patients completed the study.…”

Section: Evidence Of the Effect Of Eryfotona Ak-nmsc Vs Very High Promentioning

confidence: 99%

“…This effect was statistically significant 3 months after initiating the treatment and persisted as a strong trend until the end of the study (6 months). In the subgroup of patients with less than 10 lesions, only 14% of the Eryfotona AK-NMSC-treated patients presented new lesions at the end of the study compared to 54% of the patients using sunscreen [ 53 ].…”

Section: Evidence Of the Effect Of Eryfotona Ak-nmsc Vs Very High Promentioning

confidence: 99%

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Review of Clinical Evidence over 10 Years on Prevention and Treatment of a Film-Forming Medical Device Containing Photolyase in the Management of Field Cancerization in Actinic Keratosis

Puig

Granger

Garre

et al. 2019

Dermatol Ther (Heidelb)

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Actinic keratosis (AK) is a common pathology that afflicts sun-exposed areas of the skin. It predominantly affects older and fair-skinned individuals suggesting an accumulative damage attributable to chronic sun exposure. The prevalence of AK has risen in the past decades and is expected to continue to rise. Apart from visible hyperkeratotic, hyperplastic lesions, AK is also associated with the presence of subclinical lesions adjacent to tumor tissue, which has led to the use of the concept “cancerization field”. Although lesion- and field-targeting treatments are currently available, many are associated with local side effects and recurrence of new lesions. This review provides information on AK pathophysiology and treatment options and summarizes the available clinical evidence supporting the use of Eryfotona AK-NMSC, a film-forming medical device with SPF 100+ containing the DNA repair enzyme photolyase, for managing AK, based on the analysis of the results of 228 patients treated with the product. Funding ISDIN funded the Article Processing Charges. Electronic supplementary material The online version of this article (10.1007/s13555-019-0294-1) contains supplementary material, which is available to authorized users.

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“…In 2017, Moscarella et al [ 64 ] conducted a randomized, double-blind, parallel-group pilot study of the product in which they used a commercially available SPF50 + sunscreen as a comparator, in 36 patients. After 6 months, both groups showed significant improvement in the endpoints of clinical evaluation, dermoscopy and reflectance confocal microscopy, while in the “mild” AK subgroup (≤ 10 AK lesions in target area at baseline), the Eryfotona group showed a greater improvement than the sunscreen alone group (− 3.8 lesions vs. − 2.7 lesions, respectively) and fewer new lesions (+ 0.01 and + 1.5, respectively).…”

Section: From Photoprotect To Photorepair?mentioning

confidence: 99%

New Vision in Photoprotection and Photorepair

Leccia

Lebbe

Claudel³

et al. 2019

Dermatol Ther (Heidelb)

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Chronic exposure to solar radiation is associated with an increased incidence of skin cancer worldwide and more specifically with non-melanoma skin cancers and actinic keratosis. At the cellular level DNA damage is the main event following ultraviolet (UV) exposure. The kind of lesions produced depends on the wavelength and the energy profile of the radiation, with different photoproducts being formed as a result. Although endogenous DNA repair mechanisms are somewhat effective in repairing DNA, some DNA damage persists and can accumulate with chronic exposure. UV protection strategies, such as sunscreen use, are important in limiting further DNA damage. Several published studies have demonstrated the protective effect that regular use of sunscreen can have against the development of skin cancers. Newer options that aim to help repair damaged DNA may have an important role in reducing the incidence of chronic sun exposure-related photoaging and non-melanoma skin cancers. Photolyase, which is capable of repairing cyclobutane dimers formed as a result of DNA irradiation, is one such novel ingredient. In the first part of this paper we review the rationale for a combined treatment approach of photoprotection and photorepair with photolyase. In the second part we evaluate several published clinical studies, which suggest a beneficial effect in preventing new skin lesions in photodamaged skin. A strategy of photoprotection plus photorepair appears to be relevant for all persons with a high level of solar exposure and those at a higher risk for developing skin cancers.

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Management of cancerization field with a medical device containing photolyase: a randomized, double‐blind, parallel‐group pilot study

Cited by 23 publications

References 6 publications

Long-Term Efficacy of a New Medical Device Containing Fernblock® and DNA Repair Enzyme Complex in the Treatment and Prevention of Cancerization Field in Patients with Actinic Keratosis

Long-Term Efficacy of a New Medical Device Containing Fernblock® and DNA Repair Enzyme Complex in the Treatment and Prevention of Cancerization Field in Patients with Actinic Keratosis

Review of Clinical Evidence over 10 Years on Prevention and Treatment of a Film-Forming Medical Device Containing Photolyase in the Management of Field Cancerization in Actinic Keratosis

New Vision in Photoprotection and Photorepair

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