Method of Assessing Skin Cancerization and KeratosesTM (MASCK™): development and photographic validation in multiple anatomical sites of a novel assessment tool intended for clinical evaluation of patients with extensive skin field cancerization.

BACKGROUND: A range of 'field-directed' treatments is available for the management of extensive skin field cancerization (ESFC), but to date, the only validated objective quantitative tools are limited to assessment of actinic keratoses (AKs) affecting the head. AIMS: To develop a versatile quantitative instrument for objective clinical assessment of ESFC and perform initial internal validation across multiple anatomical zones. METHODS: The study comprised instrument development, pilot testing and instrument refinement and two rounds of reliability and inter-rater validation testing. The study was noninterventional and used a convenience sample of de-identified patient photographs selected based on preset criteria. An expert panel developed the instrument and scoring system via a modified Delphi voting process. A sample of 16 healthcare professionals from multiple specialties undertook the pilot testing, and a panel of seven dermatologists were involved in validation testing. Validation was determined by assessment of overall inter-rater agreement using Gwet chance-corrected agreement coefficients (ACs). RESULTS: The instrument produced, called the Method for Assessing Skin Cancer and Keratoses™ (MASCK™), comprises the Skin Field Cancerization Index (SFCIndex), derived from area of skin involvement and AKs (number and thickness), a global assessment score and a cancer-in-zone score, and uses Likert scales for quantitative scoring. The SFCIndex is a composite score comprising the number and thickness of AKs multiplied by area of skin involvement. ACs for the SFCIndex components, the overall SFCIndex score and the global assessment score were > 0.80 (rated 'almost perfect') while the AC for the cancer-in-zone metric was lower (0.33, rated 'fair'). Internal consistency was demonstrated via positive correlation between the overall SFCIndex score and the global assessment score. CONCLUSIONS: Our study found near-perfect agreement in inter-rater reliability when using MASCK to assess the severity of ESFC in multiple anatomical sites. Further validation of this novel instrument is planned to specifically assess its reliability, utility and feasibility in clinical practice.

Prevalence and associated factors of skin cancer in aged nursing home residents: A multicenter prevalence study.

Non-melanoma-skin cancer is an emerging clinical problem in the elderly, fair skinned population which predominantly affects patients aged older than 70 years. Its steady increase in incidence rates and morbidity is paralleled by related medical costs. Despite the fact that many elderly patients are in need of care and are living in nursing homes, specific data on the prevalence of skin cancer in home care and the institutional long-term care setting is currently lacking. A representative multicenter prevalence study was conducted in a random sample of ten institutional long-term care facilities in the federal state of Berlin, Germany. In total, n = 223 residents were included. Actinic keratoses, the precursor lesions of invasive cutaneous squamous cell carcinoma were the most common epithelial skin lesions (21.1%, 95% CI 16.2 to 26.9). Non-melanoma skin cancer was diagnosed in 16 residents (7.2%, 95% CI 4.5 to 11.3). None of the residents had a malignant melanoma. Only few bivariate associations were detected between non-melanoma skin cancer and demographic, biographic and functional characteristics. Male sex was significantly associated with actinic keratosis whereas female sex was associated with non-melanoma skin cancer. Smoking was associated with an increased occurrence of non-melanoma skin cancer. Regular dermatology check-ups in nursing homes would be needed but already now due to financial limitations, lack of time in daily clinical practice and limited number of practising dermatologists, it is not the current standard. With respect to the worldwide growing aging population new programs and decisions are required. Overall, primary health care professionals should play a more active role in early diagnosis of skin cancer in nursing home residents. Dermoscopy courses, web-based or smartphone-based applications and teledermatology may support health care professionals to provide elderly nursing home residents an early diagnosis of skin cancer.

5-aminolaevulinic acid nanoemulsion is more effective than methyl-5-aminolaevulinate in daylight photodynamic therapy for actinic keratosis: a nonsponsored randomized double-blind multicentre trial.

BACKGROUND: Daylight photodynamic therapy (DL-PDT) with methyl-5-aminolaevulinate (MAL) is an effective treatment for mild and moderate actinic keratosis (AK). OBJECTIVES: To assess the clinical efficacy, tolerability and cost-effectiveness of 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) compared with MAL in DL-PDT for grade I-II AKs. METHODS: This nonsponsored, prospective randomized double-blind multicentre trial included 69 patients with 767 grade I-II AKs located symmetrically on the face or scalp. A single DL-PDT was given in a randomized split-face design. The primary outcome was clearance of the AKs at 12 months as assessed by a blinded observer. The secondary outcomes were pain, treatment reactions, cosmetic outcome and the cost-effectiveness of the therapy. RESULTS: In the per-patient (half-face) analysis, clearance was better for the BF-200 ALA sides than for those treated with MAL (P = 0·008). In total, BF-200 ALA cleared 299/375 AKs (79·7%) and MAL 288/392 (73·5%) (P = 0·041). The treatment was practically painless with both photosensitizers, the mean pain visual analogue scale being 1·51 for BF-200 ALA and 1·35 for MAL (P = 0·061). Twenty-six patients had a stronger skin reaction on the BF-200 ALA side, seven on the MAL side and 23 displayed no difference (P = 0·001). The cosmetic outcome was excellent or good in > 90% of cases with both photosensitizers (P = 1·000). The cost-effectiveness plane showed that the costs of DL-PDT were similar for both photosensitizers, but the effectiveness was slightly higher for BF-200 ALA. CONCLUSIONS: Our results indicate that BF-200 ALA is more effective than MAL in DL-PDT for grade I-II AKs. BF-200 ALA provides slightly better value for money than MAL.

Assessment of Efficacy and Irritation of Ingenol Mebutate Gel 0.015% Used With or Without Dimethicone Lotion for Treatment of Actinic Keratosis on the Face.

Background: Ingenol mebutate gel 0.015% provides high clearance rates for actinic keratosis (AK) on the face and scalp but causes transient local skin responses (LSRs).

Objective: This study sought to determine whether the application of 1% dimethicone would decrease ingenol mebutate-associated LSRs and/or affect efficacy during the treatment of multiple AKs on the face.

Methods: Ingenol mebutate gel 0.015% was applied for 3 days to two 25 cm2 areas, each containing 3 to 8 AKs on the face of each subject, followed by application of 1% dimethicone lotion in an investigator-blinded manner to one randomly selected AK-containing area until LSRs were no longer present.

Results: In total, 20 subjects were enrolled and completed the study. Topical 1% dimethicone lotion applied during and after treatment of facial AK with ingenol mebutate gel 0.015% reduced mean total LSR scores at days 8 and 15 compared with ingenol mebutate gel only, although the difference was not statistically significant. Efficacy was equivalent between the two treatment arms.

Limitations: The study evaluated a relatively small number of subjects, all of whom were white.

Conclusions: The application of 1% dimethicone following ingenol mebutate gel 0.015% produced a trend toward lower severity of some LSRs, with no difference in efficacy.

J Drugs Dermatol. 2017;16(5):432-436.

Current perspective on actinic keratosis: a review.

Actinic keratoses (AKs) are common, with prevalence in the U.S.A. estimated at almost 40 million in 2004 and annual costs of > $1 billion (U.S.D.). However, there is no universally accepted definition of AK and thus it is difficult to identify reliably. AKs are lesions of epidermal keratinocytic dysplasia that result from chronic sun exposure and have the ability to progress to invasive squamous cell carcinoma (SCC), but clinicians disagree about whether AKs are premalignant lesions, superficial SCCin situ or epiphenomena of chronically sun-damaged skin. Yearly AK to SCC progression rates of 0·6% were reported in an elderly population with multiple prior keratinocyte carcinomas (KCs); and rates of spontaneous AK regression have been reported to be > 50%, but regressed lesions often reappear. As AKs have both cosmetic consequences and potential for malignant transformation, there are multiple reasons for treatment. There is no current agreement on the most efficacious treatment, but 5-fluorouracil has been shown to both prevent and treat AKs, and imiquimod and photodynamic therapy may have the best cosmetic outcomes. AKs may be treated to improve appearance and relieve symptoms, but the keratinocytic dysplasia that gives rise to malignancy, and sometimes appears as an AK, may be what actually threatens patient health. Thus, treatments should aim to decrease the risk of KC or facilitate KC diagnosis by reducing the potential for misidentification created when a KC appears in a field of AKs. Improved agreement among clinicians on AK definition may improve management.

Evaluation of Resource Utilization and Treatment Patterns in Patients with Actinic Keratosis in the United States.

OBJECTIVE: To compare health care resource utilization and treatment patterns between patients with actinic keratosis (AK) treated with ingenol mebutate gel (IngMeb) and those treated with other field-directed AK therapies. METHODS: A retrospective, propensity-score-matched, cohort study compared refill/repeat and adding-on/switching patterns and outpatient visits and prescriptions (health care resource utilization) over 6 months in patients receiving IngMeb versus those receiving imiquimod, 5-fluorouracil, diclofenac sodium, and methyl aminolevulinate or aminolevulinic acid photodynamic therapy (MAL/ALA-PDT). RESULTS: The final sample analyzed included four matched treatment cohort pairs (IngMeb and comparator; n = 790-971 per treatment arm). Refill rates were similar except for imiquimod (15% vs. 9% for imiquimod and IngMeb, respectively; P < 0.05). MAL/ALA-PDT treatment repetition rates were higher than IngMeb refill rates (20% vs. 10%; P < 0.05). Topical agent add-on/switch rates were comparable. PDT had higher switch rates than did IngMeb (5% vs. 2%; P < 0.05). The IngMeb cohort had a significantly lower proportion of patients with at least one AK-related outpatient visit during the 6-month follow-up than did any other cohort: versus imiquimod (50% vs. 66%; P < 0.0001), versus 5-fluorouracil (50% vs. 69%; P < 0.0001), versus diclofenac sodium (51% vs. 56%; P = 0.034), and versus MAL/ALA-PDT (50% vs. 100%; P < 0.0001). There were significantly fewer AK-related prescriptions among patients receiving IngMeb than among patients in other cohorts. CONCLUSIONS: Results based on the first 6 months after treatment initiation suggested that most field-directed AK therapies had clinically comparable treatment patterns except imiquimod, which was associated with higher refill rates, and PDT, which was associated with significantly more frequent treatment sessions and higher switching rates. IngMeb was also associated with significantly fewer outpatient visits than were other field-directed therapies.

[Assessment of skin photoaging in middle-aged and elder patients with non-melanoma skin cancers].

The development of methods of early detection of non-melanoma skin cancers, assessment of risk factors, including photoaging, by means of non-invasive techniques are the main research interests of modern dermato-oncology and gerontology. In our study we aim to investigate the range of clinical features of photoaging in 92 patients older than 50 years (50 patients had malignant epithelial skin tumors (actinic keratosis, basal cell carcinoma), to reveal risk factors for basal-cell carcinoma using adapted SCINEXA scale and to assess of the pathomorphological features of dermathoheliosis using reflectance confocal microscopy. The assessment of photoaging by means of SCINEXA with subsequent non-invasive evaluation using reflectance confocal microscopy allows to evaluate the cumulative effect of the ultraviolet irradiation on the skin with objective criteria. That algorithm is perspective in terms of early detection of the risk factors of non-melanoma skin cancers.

Photodynamic Therapy for Actinic Keratoses: A Randomized Prospective Non-sponsored Cost-effectiveness Study of Daylight-mediated Treatment Compared with Light-emitting Diode Treatment.

Daylight-mediated photodynamic therapy (DL-PDT) is considered as effective as conventional PDT using artificial light (light-emitting diode (LED)-PDT) for treatment of actinic keratoses (AK). This randomized prospective non-sponsored study assessed the cost-effectiveness of DL-PDT compared with LED-PDT. Seventy patients with 210 AKs were randomized to DL-PDT or LED-PDT groups. Effectiveness was assessed at 6 months. The costs included societal costs and private costs, including the time patients spent in treatment. Results are presented as incremental cost-effectiveness ratio (ICER). The total costs per patient were significantly lower for DL-PDT (€132) compared with LED-PDT (€170), giving a cost saving of €38 (p = 0.022). The estimated probabilities for patients' complete response were 0.429 for DL-PDT and 0.686 for LED-PDT; a difference in probability of being healed of 0.257. ICER showed a monetary gain of €147 per unit of effectiveness lost. DL-PDT is less costly and less effective than LED-PDT. In terms of cost-effectiveness analysis, DL-PDT provides lower value for money compared with LED-PDT.

Teledermatology: its use in the detection and management of actinic keratosis.

Teledermatology can profoundly improve access to medical services for those who may have limited access to dermatology due to workforce shortages or limitations in their mobility or who are located far from providers. Two common methods of teledermatology are synchronous live methods, where the patient and doctor directly communicate, and asynchronous store-and-forward methods, where the patient and doctor independently provide and assess the medical information. Teledermatology has been tested for its safety, feasibility and accuracy for a number of dermatological conditions, including the early detection of skin cancer, and is considered safe, feasible and accurate. Studies have reported somewhat better results for synchronous than asynchronous methods, possibly due to the loss of information if no direct patient doctor contact was feasible. However, asynchronous methods are easier to organise, require less-sophisticated technology and are more widely accessible and convenient for both patients and doctors. No study to date has focused solely on teledermatology for actinic keratosis, but such lesions are typically found during teledermatology examinations for other main target lesions. In studies where such results were reported, actinic keratoses seemed to be readily identifiable for teledermatologists, and adequate management and treatment can be suggested within remote consultations.

Skin cancer prevention campaign aimed at beachgoers on the Costa del Sol (southern Spain).

BACKGROUND: Sunbathing on the beach is one of the main risks for skin cancer. OBJECTIVE: In the summer of 2010, a skin cancer prevention campaign aimed at beachgoers was undertaken on the western Costa del Sol (southern Spain). METHODS: The campaign took place on beaches during July and August. A multicomponent intervention was conducted by a dermatologist and other healthcare professionals, including: (1) interviews about risk factors and sun protection habits; (2) full skin examination using dermoscopy; (3) health advice plus educational brochure; (4) sunscreen workshop plus free samples; and (5) survey about satisfaction and behavioral intentions. A journalism and health prize was offered to encourage mass media coverage. RESULTS: Four hundred and seven beachgoers (56% tourists) were recruited during the campaign, mean age 45 years. Most of the participants reported high-risk sun exposure and revealed high rates of clinically suspicious lesions of skin cancer (8.1%), melanoma (2.9%), actinic keratosis (10.2%), and atypical nevus (7.6%). The campaign was highly appreciated by the participants and followed not only by local but also regional and national media. CONCLUSION: Beachgoers are a strategic target to prevent skin cancer. Beaches are also suitable places to develop a skin cancer prevention campaign, allowing direct access to the high-risk population for surveying, health behavior education, and screening. Several keys may be useful to optimize results as the design of a personalized intervention of proven efficacy, provision of a trained healthcare team, and development of an attractive strategy for the mass media.

The significance of reflectance confocal microscopy in the assessment of solitary pink skin lesions.

BACKGROUND: Solitary pink lesions often manifest nondescript clinical and dermatoscopic primary morphologic features. The differential diagnosis for pink lesions tends, therefore, to be broad, ranging from inflammatory processes to malignancy. In vivo reflectance confocal microscopy (RCM) may help in the evaluation of pink lesions. OBJECTIVE: We sought to demonstrate the use of RCM as an adjunct to the bedside diagnosis of pink lesions. METHODS: We describe a series of patients with clinically and dermatoscopically equivocal pink lesions for which RCM examination allowed for a rapid and accurate diagnosis. All lesions were excised for histopathologic evaluation. Integrating the findings in the case series with a literature review, we present RCM diagnostic criteria for pink lesions. RESULTS: Lesions included basal cell carcinoma, squamous cell carcinoma, amelanotic melanoma, and inflamed seborrheic keratosis. RCM shows distinctive findings for each diagnostic entity when stratified by anatomic level into suprabasal epidermis, dermoepidermal junction, and papillary dermis. In the cases presented RCM allowed for a rapid and accurate noninvasive diagnosis. LIMITATIONS: The study is descriptive and does not test accuracy of RCM criteria in a prospective series of pink lesions. CONCLUSION: RCM may add useful diagnostic features to the clinical evaluation of solitary pink lesions.