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High SPF sunscreen provides significant clinical benefit in actual use conditions: SPF 100+ is more effective than SPF 50+
5690
4389
High frequency ultrasound in melanoma and nonmelanoma skin cancer early diagnosis Valentina Dini, MD, Universita of Pisa; Teresa Oranges, MD, University of Pisa; Amanda Mazzi, MD, University of Pisa; Agata Janowska, MD, University of Pisa; Francesco Faita, PhD, Italian National Research Council; Marco Romanelli, MD, University of Pisa
High SPF sunscreen provides significant clinical benefit in actual use conditions: SPF 100+ is more effective than SPF 50+ Joshua Williams, Johnson & Johnson Consumer Inc.; Prithwi Maitra, Johnson & Johnson Consumer Inc.; Evren Atillasoy, Johnson & Johnson Consumer Inc.; Mei-Miau Wu, Johnson & Johnson Consumer Inc.; Aaron Farberg, Icahn School of Medicine at Mount Sinai; Darrel Rigel, Johnson & Johnson Consumer Inc.
The clinical differential diagnosis between malignant and benign skin lesions is sometimes difficult, and dermoscopy may help the clinician to identify which lesion requires skin biopsy or surgical excision. The dermoscopic evaluation of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) often shows pathognomonic features but sometimes is not easy to identify if precancerous actinic keratosis evolved to squamous cell carcinoma without histologic examination. Clinical and dermoscopic differential diagnosis between atypical nevi and in situ superficial spreading melanoma is a big challenge. The analysis of vascular pattern in pigmented lesions is usually not possible because vessels are not visible with dermoscope. There is not experience in ultra high-frequency ultrasound assessment of skin lesions. We performed clinical, dermoscopic, and 70-MHz Doppler ultrasound evaluation of 10 actinic keratoses, 10 BBC, 5 SCC, 10 melanomas, and 5 atypical nevi. We collected clinical, dermoscopic, and ultrasound images of all lesions. We compared dermoscopic and Doppler ultrasound features. All diagnoses were confirmed with histologic examination. We observed typical dermoscopic features in the lesions and vascular features in non-pigmented lesions. Basal cell carcinoma showed prominent arborizing vessels and vascular structures were not clearly distinguishable in melanomas and atypical nevi. 70-MHz ultrasound showed hyperechoic appearance of hyperkeratosis and fibrosis and hypoechoic appearance of nodular neoplastic lesions. Doppler evaluation showed the presence of vascularization in all malignant neoplastic lesions but not in atypical nevi. Vascular pattern of actinic keratoses was mild and irregular, in epitheliomas was prominent and arborizing and in melanomas was prominent with palisade-like distribution. The ultra high-frequency ultrasound assessment of skin lesions highlights specific patterns of vascularization in pre-cancerous and cancerous lesions, which are sometimes not visible with clinical and dermoscopic analysis. This examination could be useful to early diagnose malignant skin lesions and to distinguish atypical nevi from melanomas. The early diagnosis of melanomas and the ultrasound differentiation from atypical nevi could help the physicians to avoid inappropriate surgical excisions of benign pigmented lesions and to prevent the progression of melanomas with a prompt excision of the malignant lesions. Commercial support: None identified.
In the 2011 proposed monograph, the US Food and Drug Administration requested additional data stating ‘‘there is currently insufficient evidence that there is clinical benefit to the consumer at SPF above 50.’’ In real-world settings, consumers apply sunscreens at densities lower than are used to clinically determine SPF and the linear dependence of SPF to application density is well established. It is hypothesized that a sunscreen with a higher SPF would provide greater in-use efficacy compared with one currently labeled at the proposed maximum of SPF 50+. The objective this study was to evaluate the difference in sunburn protection provided by different SPF sunscreens during a day of downhill snow skiing. Healthy men and women $18 years of age participated in a one day split face, randomized, double blind study in Vail, Colorado. The difference in sunburn protection provided by two currently available sunscreens (SPF 50+ and SPF 100+) was evaluated. Products were supplied in a kit containing two overwrapped tubes of sunscreen marked ‘‘right’’ and ‘‘left.’’ Each subject wore both sunscreens simultaneously, with product application randomized to either the right or left side of the face. Subjects were to use the sunscreens as they would normally during ski activities. Diaries were used to record sun exposure time and the frequency and timing of sunscreen reapplications. Subjects reported the next morning for clinical evaluation. The primary endpoint was a bilateral sunburn comparison between treatment areas (left and right sides of the face). The secondary endpoint was the erythema score of each side of the face, graded using a 5-point scale. A total of 199 subjects (42% women, 37 6 16 years old) were enrolled. After sun exposure, 55.3% of subjects were more sunburned on the SPF 50+ side than the SPF 100+ side, whereas only 5% of subjects were more sunburned on the SPF 100+ side (P \ .001). Clinical grading showed 23 more increase in erythema on the SPF 50+ side compared with the SPF 100+ side. No differences were observed between the SPF 50+ or SPF 100+ sides in the amount ( 6 SD) of sunscreen used (1.15 6 1.76 g SPF 50+ vs 1.09 6 1.62 g SPF 100+) or in the frequency of sunscreen reapplications (1.1 6 1.0 SPF 50+ vs 1.1 6 1.0 SPF 100+). The average duration of sun exposure for all subjects was 6.05 6 1.29 hours. In conclusion, SPF 100+ sunscreen demonstrated a clear clinical benefit over SPF 50+ sunscreen in the prevention of sunburn under actual usage conditions. Commercial support: Study sponsored by Johnson & Johnson Consumer Inc.
4358 High patient satisfaction and improved cosmetic outcomes after a 3-day field treatment of actinic keratoses with ingenol disoxate on the face, chest, and balding scalp Brian Berman, MD, Center for Clinical and Cosmetic Research; Stephen Tyring, MD, Center for Clinical Studies; Walter K Nahm, MD, University Clinical Trials, Inc.; Marie Louise Østerdal, MS, LEO Pharma A/S; Astrid H Petersen, PhD, LEO Pharma A/S; Daniel M Siegel, PhD, Long Island Skin Cancer and Dermatologic Surgery Introduction and Objectives: Ingenol disoxate (IngDsx, LEO 43204) is a novel ingenol derivative selected based on improved thermostability and biologic properties over those of ingenol mebutate (IngMeb). Previous studies demonstrated satisfaction and cosmetic improvements in patients treated with IngMeb. As part of a phase 2 trial, we investigated these outcomes for field treatment with IngDsx in patients with actinic keratoses (AK) on face/chest (F/C) and scalp (S) (NCT02305888). Materials and Methods: Open label, parallel group, 8-week trial of IngDsx gel applied as field treatment once daily for 3 consecutive days to full face or approx. 250 cm2 on the chest (0.018% IngDsx, F/C) or up to 250 cm2 on the scalp (0.037% IngDsx, S) in patients with 5-20 clinically typical AKs in the treatment area. Investigator assessed the patient’s photodamage before treatment and on Week 8, and assessed the patient’s overall global photodamage outcome at Week 8. Patients completed a cosmetic outcome questionnaire assessing overall appearance and overall feel of treatment area, as well as a treatment satisfaction questionnaire for medication (TSQM) on Week 8. Results: Sixty-three patients were included in each of the treatment groups, and 95% (F/C) and 98% (S) completed the 3-day treatment. The median age was 64 (F/C) and 68 (S) years; 63% (F/C) and 98% (S) were men. Global photodamage outcome investigator assessment showed improvement for 66% (F/C) and 69% (S) of patients, with marked improvement for 15% (F/C) and 18%(S) after treatment with IngDsx. With regards to the cosmetic outcome for the treated area, more than 90% of patients reported improved cosmetic outcome. Much improved in overall appearance was reported by 68% (F/C) and 79% (S); much improved in overall feel was reported by 71% (F/C) and 77% (S). The mean treatment satisfaction scores were high for each of the 4 domains in the TSQM (effectiveness, side effects, convenience and global satisfaction) in each treatment group (ranging from 73.9 to 91.3 out of 100). The mean global satisfaction score was not statistically significantly lower in subjects who reported application site pain as an adverse event. Conclusions: A 3-day treatment with 0.018% ingenol disoxate as field treatment of AK on full face or a large area on the chest and 0.037% ingenol disoxate as field treatment of AK on the balding scalp was associated with a high compliance, improved cosmetic outcome and high global treatment satisfaction.
Sunscreen usage is integral for the primary prevention of long-term solar exposure skin health consequences, including premature aging and cancer. It is hypothesized that under actual use conditions during multiple periods of natural light exposure, a high SPF sunscreen (SPF100+) will provide greater efficacy for sunburn and cumulative skin damage prevention when compared to a sunscreen currently labeled at the US FDA proposed maximum of SPF 50+. Healthy adults participated in a multiday split face/body, randomized, double blind study in St. Petersburg, Florida to evaluate two marketed sunscreens (SPF 50+ and SPF 100+), with products supplied in overwrapped tubes. Sun exposure areas were standardized to the face, arms, and lower legs and each subject wore both sunscreens simultaneously, with side of product application randomized. Subjects self-applied and reapplied the sunscreens at their discretion over a period of up to 5 consecutive days of a controlled 5-hour natural sunlight regimen as would commonly be received during a beach vacation. Clinical and instrumental assessments were conducted each morning, and subjects presenting with sunburn were suspended from further exposure. The primary clinical endpoints were bilateral sunburn comparison and erythema score using a 5-point scale for each exposure area. Cumulative skin damage was assessed via instrumental quantification of skin pigmentation. A total of 55 subjects (67% women, 45 6 11 years old) completed the study. Bilateral comparison scores for all subjects and exposure areas prior to suspension revealed a highly significant treatment effect of -0.091 (P \ .001) indicating the SPF 100+ product provided greater sunburn protection. This result was supported by erythema scores over the same population indicating that any erythema observed on the SPF 100+ protected side was significantly less severe, -0.080 (P \ .001). Instrumental evaluation of all exposure sites for all subjects at the study conclusion demonstrated that the SPF 100+ sunscreen provided a greater than 20% reduction in cumulative skin damage as indicated by pigmentation and a greater than 45% reduction in erythema (P\.001 for both results). Both products were well tolerated. In conclusion, under actual usage conditions SPF 100+ sunscreen demonstrated a clinical benefit over SPF 50+ sunscreen, not only in protection from sunburn but also in the cumulative reduction of skin damage.
Commercial support: 100% supported by LEO Pharma A/S.
Commercial support: Study sponsored by Johnson & Johnson Consumer Inc.
AB154
J AM ACAD DERMATOL
4388 High SPF sunscreen provides significantly better sunburn protection and reduces cumulative skin damage during a multiday beach clinical study: SPF 100+ is more effective than SPF 50+ Joshua Williams, PhD, Johnson & Johnson Consumer Inc.; Prithwiraj Maitra, PhD, Johnson & Johnson Consumer Inc.; InSeok Seo, PhD, Johnson & Johnson Consumer Inc.; Heather Smith, BS, Johnson & Johnson Consumer Inc.; Xiaoyan Tian, MS, Johnson & Johnson Consumer China Ltd.; Mei-Miau Wu, PhD, Johnson & Johnson Consumer Inc.
JUNE 2017
4389
High frequency ultrasound in melanoma and nonmelanoma skin cancer early diagnosis Valentina Dini, MD, Universita of Pisa; Teresa Oranges, MD, University of Pisa; Amanda Mazzi, MD, University of Pisa; Agata Janowska, MD, University of Pisa; Francesco Faita, PhD, Italian National Research Council; Marco Romanelli, MD, University of Pisa
High SPF sunscreen provides significant clinical benefit in actual use conditions: SPF 100+ is more effective than SPF 50+ Joshua Williams, Johnson & Johnson Consumer Inc.; Prithwi Maitra, Johnson & Johnson Consumer Inc.; Evren Atillasoy, Johnson & Johnson Consumer Inc.; Mei-Miau Wu, Johnson & Johnson Consumer Inc.; Aaron Farberg, Icahn School of Medicine at Mount Sinai; Darrel Rigel, Johnson & Johnson Consumer Inc.
The clinical differential diagnosis between malignant and benign skin lesions is sometimes difficult, and dermoscopy may help the clinician to identify which lesion requires skin biopsy or surgical excision. The dermoscopic evaluation of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) often shows pathognomonic features but sometimes is not easy to identify if precancerous actinic keratosis evolved to squamous cell carcinoma without histologic examination. Clinical and dermoscopic differential diagnosis between atypical nevi and in situ superficial spreading melanoma is a big challenge. The analysis of vascular pattern in pigmented lesions is usually not possible because vessels are not visible with dermoscope. There is not experience in ultra high-frequency ultrasound assessment of skin lesions. We performed clinical, dermoscopic, and 70-MHz Doppler ultrasound evaluation of 10 actinic keratoses, 10 BBC, 5 SCC, 10 melanomas, and 5 atypical nevi. We collected clinical, dermoscopic, and ultrasound images of all lesions. We compared dermoscopic and Doppler ultrasound features. All diagnoses were confirmed with histologic examination. We observed typical dermoscopic features in the lesions and vascular features in non-pigmented lesions. Basal cell carcinoma showed prominent arborizing vessels and vascular structures were not clearly distinguishable in melanomas and atypical nevi. 70-MHz ultrasound showed hyperechoic appearance of hyperkeratosis and fibrosis and hypoechoic appearance of nodular neoplastic lesions. Doppler evaluation showed the presence of vascularization in all malignant neoplastic lesions but not in atypical nevi. Vascular pattern of actinic keratoses was mild and irregular, in epitheliomas was prominent and arborizing and in melanomas was prominent with palisade-like distribution. The ultra high-frequency ultrasound assessment of skin lesions highlights specific patterns of vascularization in pre-cancerous and cancerous lesions, which are sometimes not visible with clinical and dermoscopic analysis. This examination could be useful to early diagnose malignant skin lesions and to distinguish atypical nevi from melanomas. The early diagnosis of melanomas and the ultrasound differentiation from atypical nevi could help the physicians to avoid inappropriate surgical excisions of benign pigmented lesions and to prevent the progression of melanomas with a prompt excision of the malignant lesions. Commercial support: None identified.
In the 2011 proposed monograph, the US Food and Drug Administration requested additional data stating ‘‘there is currently insufficient evidence that there is clinical benefit to the consumer at SPF above 50.’’ In real-world settings, consumers apply sunscreens at densities lower than are used to clinically determine SPF and the linear dependence of SPF to application density is well established. It is hypothesized that a sunscreen with a higher SPF would provide greater in-use efficacy compared with one currently labeled at the proposed maximum of SPF 50+. The objective this study was to evaluate the difference in sunburn protection provided by different SPF sunscreens during a day of downhill snow skiing. Healthy men and women $18 years of age participated in a one day split face, randomized, double blind study in Vail, Colorado. The difference in sunburn protection provided by two currently available sunscreens (SPF 50+ and SPF 100+) was evaluated. Products were supplied in a kit containing two overwrapped tubes of sunscreen marked ‘‘right’’ and ‘‘left.’’ Each subject wore both sunscreens simultaneously, with product application randomized to either the right or left side of the face. Subjects were to use the sunscreens as they would normally during ski activities. Diaries were used to record sun exposure time and the frequency and timing of sunscreen reapplications. Subjects reported the next morning for clinical evaluation. The primary endpoint was a bilateral sunburn comparison between treatment areas (left and right sides of the face). The secondary endpoint was the erythema score of each side of the face, graded using a 5-point scale. A total of 199 subjects (42% women, 37 6 16 years old) were enrolled. After sun exposure, 55.3% of subjects were more sunburned on the SPF 50+ side than the SPF 100+ side, whereas only 5% of subjects were more sunburned on the SPF 100+ side (P \ .001). Clinical grading showed 23 more increase in erythema on the SPF 50+ side compared with the SPF 100+ side. No differences were observed between the SPF 50+ or SPF 100+ sides in the amount ( 6 SD) of sunscreen used (1.15 6 1.76 g SPF 50+ vs 1.09 6 1.62 g SPF 100+) or in the frequency of sunscreen reapplications (1.1 6 1.0 SPF 50+ vs 1.1 6 1.0 SPF 100+). The average duration of sun exposure for all subjects was 6.05 6 1.29 hours. In conclusion, SPF 100+ sunscreen demonstrated a clear clinical benefit over SPF 50+ sunscreen in the prevention of sunburn under actual usage conditions. Commercial support: Study sponsored by Johnson & Johnson Consumer Inc.
4358 High patient satisfaction and improved cosmetic outcomes after a 3-day field treatment of actinic keratoses with ingenol disoxate on the face, chest, and balding scalp Brian Berman, MD, Center for Clinical and Cosmetic Research; Stephen Tyring, MD, Center for Clinical Studies; Walter K Nahm, MD, University Clinical Trials, Inc.; Marie Louise Østerdal, MS, LEO Pharma A/S; Astrid H Petersen, PhD, LEO Pharma A/S; Daniel M Siegel, PhD, Long Island Skin Cancer and Dermatologic Surgery Introduction and Objectives: Ingenol disoxate (IngDsx, LEO 43204) is a novel ingenol derivative selected based on improved thermostability and biologic properties over those of ingenol mebutate (IngMeb). Previous studies demonstrated satisfaction and cosmetic improvements in patients treated with IngMeb. As part of a phase 2 trial, we investigated these outcomes for field treatment with IngDsx in patients with actinic keratoses (AK) on face/chest (F/C) and scalp (S) (NCT02305888). Materials and Methods: Open label, parallel group, 8-week trial of IngDsx gel applied as field treatment once daily for 3 consecutive days to full face or approx. 250 cm2 on the chest (0.018% IngDsx, F/C) or up to 250 cm2 on the scalp (0.037% IngDsx, S) in patients with 5-20 clinically typical AKs in the treatment area. Investigator assessed the patient’s photodamage before treatment and on Week 8, and assessed the patient’s overall global photodamage outcome at Week 8. Patients completed a cosmetic outcome questionnaire assessing overall appearance and overall feel of treatment area, as well as a treatment satisfaction questionnaire for medication (TSQM) on Week 8. Results: Sixty-three patients were included in each of the treatment groups, and 95% (F/C) and 98% (S) completed the 3-day treatment. The median age was 64 (F/C) and 68 (S) years; 63% (F/C) and 98% (S) were men. Global photodamage outcome investigator assessment showed improvement for 66% (F/C) and 69% (S) of patients, with marked improvement for 15% (F/C) and 18%(S) after treatment with IngDsx. With regards to the cosmetic outcome for the treated area, more than 90% of patients reported improved cosmetic outcome. Much improved in overall appearance was reported by 68% (F/C) and 79% (S); much improved in overall feel was reported by 71% (F/C) and 77% (S). The mean treatment satisfaction scores were high for each of the 4 domains in the TSQM (effectiveness, side effects, convenience and global satisfaction) in each treatment group (ranging from 73.9 to 91.3 out of 100). The mean global satisfaction score was not statistically significantly lower in subjects who reported application site pain as an adverse event. Conclusions: A 3-day treatment with 0.018% ingenol disoxate as field treatment of AK on full face or a large area on the chest and 0.037% ingenol disoxate as field treatment of AK on the balding scalp was associated with a high compliance, improved cosmetic outcome and high global treatment satisfaction.
Sunscreen usage is integral for the primary prevention of long-term solar exposure skin health consequences, including premature aging and cancer. It is hypothesized that under actual use conditions during multiple periods of natural light exposure, a high SPF sunscreen (SPF100+) will provide greater efficacy for sunburn and cumulative skin damage prevention when compared to a sunscreen currently labeled at the US FDA proposed maximum of SPF 50+. Healthy adults participated in a multiday split face/body, randomized, double blind study in St. Petersburg, Florida to evaluate two marketed sunscreens (SPF 50+ and SPF 100+), with products supplied in overwrapped tubes. Sun exposure areas were standardized to the face, arms, and lower legs and each subject wore both sunscreens simultaneously, with side of product application randomized. Subjects self-applied and reapplied the sunscreens at their discretion over a period of up to 5 consecutive days of a controlled 5-hour natural sunlight regimen as would commonly be received during a beach vacation. Clinical and instrumental assessments were conducted each morning, and subjects presenting with sunburn were suspended from further exposure. The primary clinical endpoints were bilateral sunburn comparison and erythema score using a 5-point scale for each exposure area. Cumulative skin damage was assessed via instrumental quantification of skin pigmentation. A total of 55 subjects (67% women, 45 6 11 years old) completed the study. Bilateral comparison scores for all subjects and exposure areas prior to suspension revealed a highly significant treatment effect of -0.091 (P \ .001) indicating the SPF 100+ product provided greater sunburn protection. This result was supported by erythema scores over the same population indicating that any erythema observed on the SPF 100+ protected side was significantly less severe, -0.080 (P \ .001). Instrumental evaluation of all exposure sites for all subjects at the study conclusion demonstrated that the SPF 100+ sunscreen provided a greater than 20% reduction in cumulative skin damage as indicated by pigmentation and a greater than 45% reduction in erythema (P\.001 for both results). Both products were well tolerated. In conclusion, under actual usage conditions SPF 100+ sunscreen demonstrated a clinical benefit over SPF 50+ sunscreen, not only in protection from sunburn but also in the cumulative reduction of skin damage.
Commercial support: 100% supported by LEO Pharma A/S.
Commercial support: Study sponsored by Johnson & Johnson Consumer Inc.
AB154
J AM ACAD DERMATOL
4388 High SPF sunscreen provides significantly better sunburn protection and reduces cumulative skin damage during a multiday beach clinical study: SPF 100+ is more effective than SPF 50+ Joshua Williams, PhD, Johnson & Johnson Consumer Inc.; Prithwiraj Maitra, PhD, Johnson & Johnson Consumer Inc.; InSeok Seo, PhD, Johnson & Johnson Consumer Inc.; Heather Smith, BS, Johnson & Johnson Consumer Inc.; Xiaoyan Tian, MS, Johnson & Johnson Consumer China Ltd.; Mei-Miau Wu, PhD, Johnson & Johnson Consumer Inc.
JUNE 2017