Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w), in patients with seborrheic keratoses: Results from 2 identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302)

Baumann, Leslie; Blauvelt, Andrew; Draelos, Zoe Diana; Kempers, Steven; Lupo, Mary P.; Schlessinger, Joel; Smith, Stacy; Wilson, David C.; Bradshaw, Mark; Estes, Esther; Shanler, Stuart D.

doi:10.1016/j.jaad.2018.05.044

Cited by 34 publications

(62 citation statements)

References 11 publications

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“…A higher mean per-patient percentage of SKs were clear (25% versus 2% or 34% versus 1%) and clear/near-clear (47% versus 10% or 54% versus 5%) with HP40 versus vehicle. Most local skin reactions, such as redness, burning, and stinging, were mild and resolved by day 106 57 .…”

Section: Treatmentmentioning

confidence: 98%

“…Two recent randomized trials (ClinicalTrials.gov identifiers: NCT02667236 and NCT02667275) compared the safety and efficacy of 40% hydrogen peroxide topical solution (HP40; Eskatat, Aclaris Therapeutics, Inc., Wayne, PA, USA) versus vehicle for the treatment of SKs. These trials included 937 patients with four SKs who were randomly assigned 1:1 to HP40 or vehicle 57 . The clinical response was graded by using the Physician’s Lesion Assessment (PLA) scale (0: clear; 1: near-clear; 2: ≤1 mm thick; and 3: >1 mm thick).…”

Section: Treatmentmentioning

confidence: 99%

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Recent advances in managing and understanding seborrheic keratosis

Wollina

2019

F1000Res

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Seborrheic keratosis (SK) is a common benign epidermal tumor with predominance in adult patients. Whereas common SKs are more frequent in Caucasians, dermatosis papulosa nigra is more prevalent in patients with a Fitzpatrick skin type of at least 3. There seems to be a link between extrinsic skin aging and the occurrence of SK. Mutations of fibroblast growth factor receptor 3 and other signaling molecules are a frequent finding in SK lesions. However, this does not translate into any malignant potential. Viral infections are particularly common in genital lesions, although their pathogenetic relevance for SK is questionable. Different histologic and clinical subtypes have been identified. The great variability of SKs raises some difficulties in diagnosis. Dermoscopy is the preferred non-invasive diagnostic method, in particular to differentiate pigmented SKs from other pigment tumors, including cutaneous melanoma. Eruptive SKs can be a paraneoplastic condition known as the Leser–Trélat sign. New targeted cancer treatments can cause a pseudo-Leser–Trélat sign. The treatment in practice is mainly minor surgery, including cryosurgery, shave excisions, and laser-assisted removal. The medical approaches have only limited effects. Recently, two formulations for topical therapy have been evaluated: a product with 40% hydrogen peroxide (HP40) and an aqueous nitric–zinc complex. Based on clinical trials, HP40 seems to be a promising alternative to surgery, in particular for facial lesions.

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Section: Treatmentmentioning

confidence: 98%

Section: Treatmentmentioning

confidence: 99%

Recent advances in managing and understanding seborrheic keratosis

Wollina

2019

F1000Res

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“…A higher mean per-patient percentage of SKs were Clear (25% vs 2 % or 34% vs 1%) and Clear/Near-Clear (47% vs 10% or 54% vs 5%) with HP40 versus VEH. Most local skin reactions were mild and resolved by day 106 [ 22 ]. HP40 may act not only through its direct oxidation of organic tissues, generation of reactive oxygen species, and local lipid peroxidation but also by the generation of local concentrations of oxygen that are toxic to SK cells [ 23 ] [ 24 ].…”

Section: Treatmentmentioning

confidence: 99%

Seborrheic Keratoses – The Most Common Benign Skin Tumor of Humans. Clinical presentation and an update on pathogenesis and treatment options

Wollina¹

2018

Open Access Maced J Med Sci

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Seborrheic keratoses (SK) are the most common skin tumour of humanity. The incidence of this purely benign epithelial proliferation is increasing with age and exposure to ultraviolet light. It has a remarkable variability in its clinical presentation raising some differential diagnoses. Recently, oncogenic mutations have been detected involved in the development of SK, which, however, do not bear the risk of malignant transformation. SK may also develop with the use of modern targeted drugs for the treatment of malignancies. The classical treatment options for SK are cryotherapy and curettage. Recently, topical treatment with 40% hydrogen peroxide and the nitric-zinc complex has been investigated. Ablative laser therapy is an effective treatment as well.

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“…1 However, if they become pruritic or cosmetically bothersome, patients may seek treatment. 4,5 Cryotherapy, which is the most common treatment modality, uses liquid nitrogen or carbon dioxide to rapidly freeze the targeted cells below −20°C. 1,5,7 The tissue is injured through both intracellular ice formation and ischemia resulting from vascular endothelial damage.…”

Section: Introductionmentioning

confidence: 99%

Hydrogen Peroxide 40% for the Treatment of Seborrheic Keratoses

et al. 2020

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Objective: Hydrogen peroxide 40% (HP40) was approved by the US Food and Drug Administration for topical treatment of seborrheic keratosis (SK) in December 2017. This article will review phase II and III clinical trials to assess the drug’s efficacy, safety, and clinical application. Data Sources: A systematic literature review was performed using the terms “Eskata AND seborrheic keratosis,” and “hydrogen peroxide AND seborrheic keratosis” in the OVID MEDLINE, PubMed, Cochrane Library, EMBASE, and Web of Science databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Abstraction: Articles written in English between January 2000 and mid-June 2020 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: In 2 phase III clinical trials, 4% and 8% of patients treated with HP40 had a Physician Lesion Assessment score of zero for all 4 SKs, respectively, compared with 0% in both vehicle groups at the primary end point of day 106 ( P < 0.01; P < 0.0001). Relevance to Patient Care and Clinical Practice: HP40, although less effective, has a better safety profile than other treatment options. It should be especially considered for treatment of facial SKs, where it is most efficacious and where other treatment modalities, such as cryotherapy, are more challenging. Conclusions: HP40 is a new, safe alternative treatment for SKs, although it is expensive and only modestly effective, both of which somewhat limit its overall utility. HP40 is a promising topical alternative, particularly for cosmetically sensitive locations, such as the face.

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Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w), in patients with seborrheic keratoses: Results from 2 identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302)

Abstract: Application of HP40 was well tolerated and effective in the removal of SKs.

Cited by 34 publications

References 11 publications

Recent advances in managing and understanding seborrheic keratosis

Recent advances in managing and understanding seborrheic keratosis

Seborrheic Keratoses – The Most Common Benign Skin Tumor of Humans. Clinical presentation and an update on pathogenesis and treatment options

Hydrogen Peroxide 40% for the Treatment of Seborrheic Keratoses

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