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ingenol mebutate

Martina Ulrich, Susanne Lange-Asschenfeldt, Kresten Skak, Torsten Skov, Marie Louise Østerdal, Hans-Joachim Röwert-Huber, John Robert Zibert, Eggert Stockfleth
Ingenol mebutate represents a topical treatment for fields with actinic keratosis (AK). The biological effects of ingenol mebutate in AK, subclinical (SC)-AK, and reference-skin were assessed and graded by in vivo reflectance confocal microscopy (RCM) and histology. Patients with AK and SC-AK lesions in one 25 cm2 field on hands or forearms, and with an area of reference skin on the inner upper arm, were included. The two fields were each treated with ingenol mebutate 0.05% gel (n=16), or vehicle (n=8), on 2 consecutive days; clinical and RCM assessments were performed on days 1, 2, 3, 8, and 57, and biopsies on day 3...
October 1, 2016: Journal of Drugs in Dermatology: JDD
S A Braun, P A Gerber
actinic field cancerization (AFC) is a frequent neoplastic skin disease with a high prevalence in the elderly population. AFC is defined as a condition with at least six actinic keratosis (AKs) in one body region or field of chronically sun-damaged skin.(1) With regard to the management of AFC a superior efficacy has been demonstrated for field-directed treatments, such as 5-fluorouracil, imiquimod, ingenol mebutate or photodynamic therapy (PDT), as compared to lesion-directed measures, such as cryotherapy...
October 12, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
Peter W Hashim, John K Nia, Skylar Singer, Gary Goldenberg
OBJECTIVES: To evaluate the safety and efficacy of ingenol mebutate 0.05% gel after cryosurgery versus cryosurgery alone for the treatment of hypertrophic and nonhypertrophic actinic keratosis on the dorsal hands. DESIGN: Investigator-blinded split arm study. SETTING: Academic institution. PARTICIPANTS: Sixteen subjects with actinic keratoses on dorsal hands. RESULTS: There was a mean reduction in the number of hypertrophic actinic keratosis lesions adjusted for baseline in ingenol mebutate-treated versus control group of -4...
July 2016: Journal of Clinical and Aesthetic Dermatology
Andrés Már Erlendsson, Daniel Thaysen-Petersen, Christiane Bay, Andreas Hald, Kresten Skak, John Robert Zibert, Uwe Paasch, Hans Christian Wulf, Merete Haedersdal
BACKGROUND AND AIM: Ingenol mebutate (IngMeb) is an effective treatment for actinic keratosis. In this study, we hypothesized that repeated treatments with IngMeb may prevent progression of UV-induced photodamage, and that concurrent application of a corticosteroid may reduce IngMeb-induced local skin responses (LSR). METHODS: Hairless mice (n = 60; 3 groups of 20 mice) were irradiated with solar simulated ultraviolet radiation (UVR) throughout the study. Five single treatments with IngMeb were given at 4-week intervals (Days 21, 49, 77, 105, and 133)...
2016: PloS One
Steffen Emmert, Holger A Haenssle, John R Zibert, Margarete Schön, Andreas Hald, Maria H Hansen, Thomas Litman, Michael P Schön
UNLABELLED: The rapid and strong clinical efficacy of the first-in-class, ingenol mebutate, against actinic keratosis (AK) has resulted in its recent approval. We conducted the first comprehensive analysis of the cellular and molecular mode of action of topical ingenol mebutate 0.05% gel in both AK and uninvolved skin of 26 patients in a phase I, single-center, open-label, within-patient comparison. As early as 1 day after application, ingenol mebutate induced profound epidermal cell death, along with a strong infiltrate of CD4+ and CD8+ T-cells, neutrophils, and macrophages...
2016: PloS One
Shelbi C Jim On, Kim Mark Knudsen, Torsten Skov, Mark Lebwohl
BACKGROUND: Ingenol mebutate gel is a topical field treatment for actinic keratosis (AK). The treatment elicits application-site reactions in most patients. This analysis evaluated the relationship between the severity of reactions and the speed of their resolution. METHODS: Patients in Phase III studies were treated for AKs on the face (n=218), scalp (n=56), and trunk and extremities (n=209). All of the patients were treated with either ingenol mebutate gel 0.015% once daily for three consecutive days (face/scalp) or ingenol mebutate gel 0...
2016: Clinical, Cosmetic and Investigational Dermatology
Cristina Zane, Antonella Fabiano, Mariachiara Arisi, Piergiacomo Calzavara-Pinton
BACKGROUND: Photodynamic therapy with methyl aminolevulinate (MAL-PDT) and ingenol mebutate gel (IMB) are approved therapeutic options for multiple actinic keratoses (AKs). OBJECTIVE: The aim of this intraindividual, split-face, randomized clinical trial was to compare treatment outcomes of MAL-PDT and IMB. METHODS: Two symmetrical contralateral areas with a similar number of AKs were selected and randomly assigned to 3 days of an IMB treatment cycle or a single session of MAL-PDT...
2016: Dermatology: International Journal for Clinical and Investigative Dermatology
Miriam S Bettencourt
BACKGROUND: Basal cell carcinoma (BCC) is the most common cancer in Caucasians. Surgical approaches are the most widely used and effective treatment strategies for well-defined BCC. However, for patients with low-risk, superficial BCCs (sBCCs), medical therapy may be a treatment option. In this small case series, we describe our experience in using topical treatment with ingenol mebutate gel, 0.05%, for patients who refused surgical treatment for sBCC. METHODS: We conducted a retrospective chart review of seven patients from our community dermatology practice for whom sBCC was treated with ingenol mebutate...
2016: Clinical, Cosmetic and Investigational Dermatology
Andrés M Erlendsson, Daniel Thaysen-Petersen, Christiane Bay, Catharina M Lerche, Peter A Philipsen, Hans Christian Wulf, John R Zibert, Merete Hædersdal
BACKGROUND AND AIM: The incidence of squamous cell carcinomas (SCC) is increasing, and effective chemopreventative strategies are needed. We hypothesized that repeated treatments with ingenol mebutate (IngMeb) would postpone development of SCC in hairless mice, and that application of a corticosteroid would reduce IngMeb-induced local skin responses (LSRs) without affecting tumor postponement. METHODS: Hairless mice (n=150; 6 groups á 25 mice) were irradiated with solar simulated ultraviolet radiation (UVR) until SCC developed...
October 2016: Journal of Photochemistry and Photobiology. B, Biology
S Izzi, P Sorgi, P Piemonte, A Carbone, P Frascione
Surgery is the therapy of choice in the guidelines to treat basal cell carcinomas (BCCs) but a variety of non-surgical options are available. The objective of this study is to evaluate the efficacy and safety of ingenol mebutate 0.05% gel for the treatment of superficial BCCs. We accepted twenty patients with superficial BCCs on the body and we treated them once daily for two consecutive days with ingenol mebutate 0.05% gel. We examined the lesions at the screening visit and after four days from the gel application to describe the local skin reaction due to the therapy...
August 23, 2016: Dermatologic Therapy
Ming Liu, Fangling Chen, Rilei Yu, Weiyi Zhang, Mei Han, Fei Liu, Jing Wu, Xingzeng Zhao, Jinlai Miao
Ingenol mebutate possesses significant cytotoxicity and is clinically used to treat actinic keratosis. However, ingenol mebutate undergoes acyl migration which affects its bioactivity. Compound 3-O-angeloyl-20-O-acetyl ingenol (AAI, also known as 20-O-acetyl-ingenol-3-angelate or PEP008) is a synthetic derivative of ingenol mebutate. In this work, we report the AAI synthesis details and demonstrate AAI has higher cytotoxicity than ingenol mebutate in a chronic myeloid leukemia K562 cell line. Our data indicate that the increased activity of AAI originates from the improved intracellular stability of AAI rather than the increased binding affinity between AAI and the target protein protein kinase Cδ (PKCδ)...
2016: International Journal of Molecular Sciences
Erica Moggio, Mariachiara Arisi, PierGiacomo Calzavara-Pinton
INTRODUCTION: Daylight photodynamic therapy with methyl aminolaevulinate (dlPDT) and ingenol mebutate gel (IMB) are approved therapeutic options for multiple actinic keratoses (AKs). The aim of this comparative, intra-patient, split- face, randomized clinical trial was to compare treatment outcomes of dlPDT and IMB. METHODS: Two symmetrical contralateral areas of 25cm(2) harboring a similar (≥5) number of AKs were selected and randomly assigned to 3 days' IMB treatment cycle or an only session of dlPDT...
August 13, 2016: Photodiagnosis and Photodynamic Therapy
M Ulrich, U Reinhold, T Skov, R Elvang Søndergaard, P Guitera
BACKGROUND: To date, studies with ingenol mebutate gel have used clinical clearance, not histological clearance, as a primary efficacy endpoint. OBJECTIVES: This phase 1, multicentre, single-arm, open-label study sought to histologically confirm clinical clearance of actinic keratoses (AKs) to support a treatment effect deep in the epidermis. METHODS: Patients (n = 108) aged ≥18 years with histologically confirmed AK within a 25-cm(2) contiguous treatment area on the trunk and extremities received ingenol mebutate 0...
August 12, 2016: British Journal of Dermatology
Mosab T Mohanna, Günther F L Hofbauer
Ingenol mebutate (IM) is a topical pharmacotherapy approved in Switzerland since 2012 for treating non-hypertrophic, non-hyperkeratotic actinic keratosis (AK). We report 2 cases with off-label use of IM. The first case of bowenoid AK was treated with 150 μg IM for 3 consecutive days with an almost complete clinical remission of the lesion. The second case of Bowen's disease was treated with 500 μg IM for 2 consecutive days leading to complete clinical remission.
2016: Dermatology: International Journal for Clinical and Investigative Dermatology
Carlo Mainetti, Caroline Guillod, Sandra Leoni-Parvex
Ingenol mebutate (IM) has recently been approved for the topical treatment of actinic keratoses. It appears to have a dual mechanism of action: rapid necrosis after gel application and a subsequent immune-mediated response, which targets any residual dysplastic epidermal cells. We report the successful treatment of a woman, who had been relapsing into Bowen's disease (BD) on her right forefinger for 8 years. During her clinical history, she had received an allogeneic, HLA-identical stem cell transplant for myeloproliferative syndrome with a JAK2V617F mutation and lobectomy of the pulmonary right lower lobe for adenocarcinoma...
2016: Dermatology: International Journal for Clinical and Investigative Dermatology
Olivier Gaide, Helena Clayton, Marie Girardin, Francois Kuonen
Patients suffering from chronic lymphocytic leukemia often develop actinic keratosis (AK) and squamous cell carcinoma in sun-exposed areas. In these particular patients, who have a suboptimal immune function, AK treatment can be particularly challenging. We report the case of a patient who failed to respond to most AK treatments, including 5-FU, imiquimod and photodynamic therapy, but responded to ingenol mebutate. We started with 3 applications of 150 μg/g (registered treatment of the scalp) and also 2 applications of 500 μg/g (registered in for trunk and extremities)...
2016: Dermatology: International Journal for Clinical and Investigative Dermatology
Olivier Gaide, Vincent Cattin
Ingenol mebutate induces strong inflammation after a single application already. This must be taken into account when prescribing the drug, as mistakes in the application may results in severe side effects. Here, we report the case of a 72-year-old woman who applied ingenol mebutate on the cheekbones and developed a pronounced conjunctivitis, needing topical corticosteroids. The treatment was intended for the actinic keratosis she had on the chest, and the regimen of 2 consecutive once daily applications of ingenol mebutate at 500 µg/g had been prescribed as registered...
2016: Dermatology: International Journal for Clinical and Investigative Dermatology
Evangelia Tzika, Isabelle Masouyé, Michael Mühlstädt, Emmanuel Laffitte
We present the case of a healthy 76-year-old man with a whitish, hyperkeratotic lesion of the lower lip diagnosed as actinic cheilitis (AC) previously treated with classic red light photodynamic therapy 5 years ago. Initial treatment with 5% imiquimod cream - also with intensified application - failed. After 2 cycles thrice daily, consecutive applications of 150 μg/g ingenol mebutate gel at 3 weeks' interval, the lesions cleared completely. Surprisingly, no pustular or crusting reaction or other side effect occurred contrary to expectation...
2016: Dermatology: International Journal for Clinical and Investigative Dermatology
Marco Stieger, Robert E Hunger
BACKGROUND: Gorlin syndrome, also known as the basal cell nevus syndrome (OMIM #109400), is a rare autosomal-dominant genetic disease. The disease, which shows mutation of the patched receptor gene (PTCH1) of the sonic hedgehog pathway, is characterized by developing multiple basal cell carcinomas (BCCs) in adolescent patients. Other clinical features include mandibular keratocysts, palmar and plantar pits, skeletal abnormalities and malformations central nervous system and genital tract...
2016: Dermatology: International Journal for Clinical and Investigative Dermatology
Karolina Gadaldi, Laurence Feldmeyer, Nikhil Yawalkar, Robert E Hunger
BACKGROUND: Lentigo maligna (LM) is a melanoma in situ on sun-damaged skin, with a strong predilection to the head and neck area of the elderly. Many therapeutic modalities have been proposed in the treatment of this pathology, including surgery, cryotherapy, radiotherapy and topical imiquimod. Up to date surgical excision remains the treatment of choice with the lowest recurrence rate. Recently, a new topical treatment with ingenol mebutate has been described to be efficacious and well tolerated in the treatment of melanoma in situ...
2016: Dermatology: International Journal for Clinical and Investigative Dermatology
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