Skin Cancer Prevention: Recent Evidence from Randomized Controlled Trials

Green, Adèle C.; Harwood, Catherine A.; Lear, John T.; Proby, Charlotte M.; Sinnya, Sudipta; Soyer, H. Peter

doi:10.1007/s13671-012-0015-9

Cited by 7 publications

(5 citation statements)

References 36 publications

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“…The clinical significance of AKs is mainly related to the malignant potential of a small proportion (1,2), but the lesions are also cosmetically disfiguring, painful and occasionally bleed (3). Existing and new therapies used for treatment of AKs rely on clinical counting as a means of measuring treatment end-point in clinical trials (4,5).…”

Section: Short Communicationmentioning

confidence: 99%

Counting Actinic Keratosis – Is Photographic Assessment a Reliable Alternative to Physical Examination in Clinical Trials?

Sinnya¹,

O’Rourke²,

Ballard³

et al. 2015

Acta Derm Venerol

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Section: Short Communicationmentioning

confidence: 99%

Counting Actinic Keratosis – Is Photographic Assessment a Reliable Alternative to Physical Examination in Clinical Trials?

Sinnya¹,

O’Rourke²,

Ballard³

et al. 2015

Acta Derm Venerol

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“…Additionally, certain risk factors including older age, fair skin and baldness are associated with a greater degree of actinic damage . Population‐based studies investigating AK prevalence and its associated risk factors concluded that elderly patients with European ancestry and high cumulative sun exposure have the highest risk of developing AKs . Previous history of skin cancer is another risk factor, as shown by the baseline characteristics of previous AK study populations …”

Section: Introductionmentioning

confidence: 99%

A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body

Pellacani

Peris

Guillén

et al. 2015

Acad Dermatol Venereol

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BackgroundActinic keratoses (AKs) are precursors to invasive squamous cell carcinoma and can progress if untreated. Limited data support the use of ingenol mebutate to treat AKs on more than one area of the body simultaneously.ObjectiveTo investigate safety, efficacy and treatment satisfaction when treating separate areas simultaneously or sequentially with different concentrations of ingenol mebutate gel.MethodsIn this phase IIIb study (NCT01787383), patients with clinically visible, non‐hyperkeratotic AKs on two separate treatment areas (face/scalp and trunk/extremities) were randomized to simultaneous or sequential treatment with ingenol mebutate gel (0.015% and 0.05%). Endpoints included composite local skin response (LSR) score 3 days after first application, complete AK clearance and percentage reduction in AKs at week 8.ResultsThere were no statistically significant differences between simultaneous (n = 101) and sequential (n = 98) groups in composite LSR score (10.4 vs. 9.7), complete clearance (52.7% vs. 46.9%) or percentage reduction in AKs (83.4% vs. 79.1%). Mean composite LSR scores on face/scalp and trunk/extremities were similar for both groups. Adverse event (AE) incidence was comparable between groups, the most common treatment‐related AEs being pruritus and pain at the application site.ConclusionTreating AKs with ingenol mebutate simultaneously or sequentially gave similar results in terms of tolerability (LSR score, AEs) and efficacy (complete clearance). Therefore, the physician and patient can select the most convenient treatment regimen, with confidence in achieving a similar outcome.

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“…8 This field change warrants prompt treatment with effective field therapies, as these are preferred sites for the development of SCC. 9 Ingenol mebutate gel (Picato â ; LEO Pharma A/S, Ballerup, Denmark) is a field therapy indicated for treating actinic keratosis. When applied topically for 2 or 3 consecutive days, ingenol mebutate has been shown to be effective for the field treatment of AKs.…”

Section: What Does This Study Add?mentioning

confidence: 99%

“…Sun‐damaged skin with confluent AKs usually harbour areas of field cancerization containing both visible and subclinical (nonvisible and nonpalpable) AKs . This field change warrants prompt treatment with effective field therapies, as these are preferred sites for the development of SCC …”

mentioning

confidence: 99%

A randomized, phase IIa exploratory trial to assess the safety and preliminary efficacy of LEO 43204 in patients with actinic keratosis

et al. 2016

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SummaryBackground LEO 43204 is a novel ingenol derivative in development for the treatment of actinic keratosis. Objectives To compare the safety and preliminary efficacy of three doses of LEO 43204 with ingenol mebutate in actinic keratoses (AKs). Methods Patients with at least three visible, discrete, nonkeratotic AKs on four separate selected treatment areas on the forearms received LEO 43204 gel (0Á025%, 0Á05% and 0Á075%) and ingenol mebutate 0Á05% gel, by investigator-blinded, randomized allocation, for 2 consecutive days. Patients were assessed at 8 weeks. Primary outcomes included maximum composite local skin response (LSR) score and adverse events (AEs). Secondary outcomes included a reduction in the number of visible AKs. Results Forty patients completed the trial. For all treatments, mean LSR scores peaked at week 1, and were below baseline by week 8. Mean maximum composite LSR scores for LEO 43204 0Á025%, 0Á05% and 0Á075% were 9Á2 (Dunnett adjusted P = 0Á02), 10Á1 (Dunnett adjusted P = 0Á90) and 11Á2 (Dunnett adjusted P < 0Á01), respectively, vs. ingenol mebutate 0Á05% gel (10Á0). The most frequent AEs across all treatments were application site pruritus, burning sensation and tenderness. Mean reduction in the number of AKs was comparable for ingenol mebutate and the two lowest doses of LEO 43204 (71Á9-73Á1%), but LEO 43204 0Á075% gave a significantly larger reduction (81Á8%; Dunnett adjusted P = 0Á04). Conclusions LEO 43204 had a similar safety profile to ingenol mebutate and a dose-response relationship for LSRs was demonstrated. The highest LEO 43204 dose (0Á075%) significantly reduced the AK count when compared with ingenol mebutate.

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Skin Cancer Prevention: Recent Evidence from Randomized Controlled Trials

Cited by 7 publications

References 36 publications

Counting Actinic Keratosis – Is Photographic Assessment a Reliable Alternative to Physical Examination in Clinical Trials?

Counting Actinic Keratosis – Is Photographic Assessment a Reliable Alternative to Physical Examination in Clinical Trials?

A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body

A randomized, phase IIa exploratory trial to assess the safety and preliminary efficacy of LEO 43204 in patients with actinic keratosis

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