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252


Understanding efficacy end-points in studies of field-directed therapy for actinic keratosis

Wolf, John E Jr; Rigel, Darrell S
BACKGROUND: The rates of short-term clearance of actinic keratoses appear to be comparable in clinical trials of topical treatments used in field therapy, but direct comparisons of efficacy results can be problematic. Trials use different efficacy end points, have different study designs, involve different anatomic sites, and enroll different patient populations. In addition, because adherence in real-world clinical practice differs from that observed in clinical trials, conclusions drawn from efficacy outcomes can be misleading. The objective of this review was to examine the efficacy end points used in studies of topical therapy for actinic keratosis, address other factors influencing efficacy outcomes in these studies, and discuss the possible influence of nonadherence on effectiveness. METHODS: Review of the available literature on topical therapy for actinic keratosis. RESULTS: The end points used to determine efficacy of therapies for actinic keratosis include a disparate group of outcomes, which can often make comparison between studies impossible. CONCLUSIONS: Efficacy end points of clinical studies designed to assess the treatment of actinic keratosis should be standardized to facilitate between-trial comparisons, and studies should focus on the end points that are most clinically relevant.
PMID: 23962263
ISSN: 0011-9059
CID: 503652

The importance of early diagnosis and treatment of actinic keratosis

Rigel, Darrell S; Stein Gold, Linda F
Chronic, long-term sun exposure results in genetic changes in epidermal keratinocytes and the development of various skin lesions ranging from actinic keratosis (AK) to skin cancer. AK lesions may first appear as rough, scaly spots on sun-exposed skin, and, although most individual AK lesions do not become invasive cancers, the majority of invasive squamous cell carcinomas originate from AK. Genetic analysis demonstrates that ultraviolet radiation-induced mutations and changes in gene expression are present in squamous cell carcinoma, AK, and clinically normal-appearing perilesional sun-exposed skin, which supports the progressive nature of keratinocyte transformation. The presence of certain clinical features, such as large size, ulceration, or bleeding, suggests an increased risk of disease progression. The risk is also increased by evidence of extensive solar damage, advanced age, and immunosuppression. Early diagnosis and consideration for treatment are indicated to clear actinically damaged sites and diminish the risk of invasive squamous cell carcinoma.
PMID: 23228303
ISSN: 0190-9622
CID: 203932

High-SPF sunscreens (SPF >/= 70) may provide ultraviolet protection above minimal recommended levels by adequately compensating for lower sunscreen user application amounts

Ou-Yang, Hao; Stanfield, Joseph; Cole, Curtis; Appa, Yohini; Rigel, Darrell
BACKGROUND: The manner in which consumers apply sunscreens is often inadequate for ultraviolet protection according to the labeled sun protection factor (SPF). Although sunscreen SPFs are labeled by testing at an application density of 2 mg/cm(2), the actual protection received is often substantially less because of consumer application densities ranging from 0.5 to 1 mg/cm(2). High-SPF sunscreens may provide more adequate protection even when applied by consumers at inadequate amounts. OBJECTIVE: We sought to measure the actual SPF values of various sunscreens (labeled SPF 30-100) applied in amounts typical of those used by consumers. METHODS: Actual SPF values were measured on human volunteers for 6 sunscreen products with labeled SPF values ranging from 30 to 100, applied at 0.5, 1.0, 1.5, and 2.0 mg/cm(2). RESULTS: There was a linear relationship between application density and the actual SPF; sunscreens with labeled SPF values of 70 and above provided significant protection, even at the low application densities typically applied by consumers. Sunscreens labeled SPF 70 and 100 applied at 0.5 mg/cm(2) provided an actual SPF value of, respectively, 19 and 27. LIMITATIONS: The study was conducted in a laboratory setting under standardized conditions and results are extrapolated to actual in-use situations. CONCLUSION: Sunscreens with SPF 70 and above add additional clinical benefits when applied by consumers at typically used amounts, by delivering an actual SPF that meets the minimum SPF levels recommended for skin cancer and photodamage prevention. In contrast, sunscreens with SPF 30 or 50 may not produce sufficient protection at actual consumer usage levels.
PMID: 22463921
ISSN: 0190-9622
CID: 185552

Current and developing techniques to diagnose melanoma

Russak, Julie E; Rigel, Darrell S
PMID: 22800558
ISSN: 0733-8635
CID: 178183

The effect of sunscreen on melanoma risk

Mulliken, Jennifer S; Russak, Julie E; Rigel, Darrell S
Total cumulative sun exposure is associated with the development of squamous cell and basal cell cancers, whereas intense intermittent sun exposure is associated with the development of melanoma. Exposure to UV radiation is the only known modifiable cause of melanoma, but the role of sunscreen in melanoma prevention remains somewhat controversial. This article discusses how UV radiation contributes to the pathogenesis of melanoma, how sunscreen modulates the action of UV radiation on the skin, and the effect of sunscreen on the risk of developing melanoma. A review of available sunscreen agents and their sun-protective properties is also included.
PMID: 22800545
ISSN: 0733-8635
CID: 173032

Risk factors for the development of primary cutaneous melanoma

Russak, Julie E; Rigel, Darrell S
Melanoma is an important public health problem in the United States and worldwide. The incidence of melanoma continues to increase at a high rate and deaths from melanoma are also increasing. The endogenous risk factors that are currently recognized are in many cases surrogates for genetic markers yet to be determined. Exogenous risk factors need to be better defined and understood to help develop better public education programs that can change risk behaviors and subsequently lower future incidence and mortality from melanoma.
PMID: 22800544
ISSN: 0733-8635
CID: 178184

The positive impact of providing information from a computer-aided multispectral digital skin lesion analysis system on melanoma biopsy sensitivity [Meeting Abstract]

Rigel, Darrell; Cockerell, Clay; Yoo, Jane; Robinson, June; Roy, Mrinalini; White, Richard
ISI:000302319800587
ISSN: 0190-9622
CID: 2734092

Impact of guidance from a computer-aided multispectral digital skin lesion analysis device on decision to biopsy lesions clinically suggestive of melanoma

Rigel, Darrell S; Roy, Mrinalini; Yoo, Jane; Cockerell, Clay J; Robinson, June K; White, Richard
PMID: 22351788
ISSN: 0003-987x
CID: 166549

The frequency of self-skin examination and full body skin examination in dermatologists

Saitta, Peter; Cohen, David E; Rigel, Darrell; Grekin, Steven K; Brancaccio, Ronald
Purpose: Mortalities due to skin cancer are escalating, but early detection via skin examinations can be beneficial. To date, dermatologists have not been isolated as a high-risk population for developing skin cancer, although some evidence suggests that they are a high-risk group. Therefore, the specific aims of this study were to measure the frequency at which dermatologists perform self-skin examination and receive full-body skin examination. Patients and methods: A sample of 476 respondents provided data for this cross-sectional, nine-item survey, which was e-mailed to all registered members in the American Society for Dermatologic Surgery. The initial invitation was sent in the summer of 2007, with reminders sent at four and eight weeks. E-mails contained a unique identifier, and each member could only respond once to the survey sent to that particular e-mail address. Results: 71.7 percent of the respondents reported that they routinely gave themselves a self-skin examination, 25.4 percent reported a monthly exam, 24.5 percent every six months, 17.2 percent once per year, and 4.6 percent every five years. Performing a self-skin examination was not related to age, gender, or history of skin malignancy. Seventy-six percent of all respondents never had a full-body skin examination conducted by another dermatologist, which persisted when analyzed by age (p = 0.0490) and gender (p = 0.0184). Conclusion: Dermatologists are more likely to perform self-skin examination rather than visit another dermatologist for a full-body skin examination
PMCID:3140903
PMID: 21779412
ISSN: 1941-2789
CID: 137963

Adverse effects of ultraviolet radiation from the use of indoor tanning equipment: time to ban the tan

Lim, Henry W; James, William D; Rigel, Darrell S; Maloney, Mary E; Spencer, James M; Bhushan, Reva
The incidence of melanoma skin cancer is increasing rapidly, particularly among young women in the United States. Numerous studies have documented an association between the use of indoor tanning devices and an increased risk of skin cancer, especially in young women. Studies have shown that ultraviolet exposure, even in the absence of erythema or burn, results in DNA damage. Countries and regulatory bodies worldwide have recognized the health risks associated with indoor tanning. In the United States, 32 states have passed legislation to regulate the indoor tanning industry, but there is an urgent need to restrict the use of indoor tanning devices at the federal level. The Food and Drug Administration is currently reviewing the classification of these devices. For all of these reasons, the Food and Drug Administration should prohibit the use of tanning devices by minors and reclassify tanning devices to at least class II to protect the public from the preventable cancers and other adverse effects caused by ultraviolet radiation from indoor tanning.
PMID: 21496701
ISSN: 0190-9622
CID: 923212