An exploratory, prospective, open-label trial of ingenol mebutate gel 0.05% for the treatment of external anogenital warts

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Standard

An exploratory, prospective, open-label trial of ingenol mebutate gel 0.05% for the treatment of external anogenital warts. / Larsen, H K; Banzhaf, C A; Thomsen, S F; Gormsen, M; Schopf, R E; Haedersdal, M.

I: Journal of the European Academy of Dermatology and Venereology, Bind 32, Nr. 5, 2018, s. 825-831.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Larsen, HK, Banzhaf, CA, Thomsen, SF, Gormsen, M, Schopf, RE & Haedersdal, M 2018, 'An exploratory, prospective, open-label trial of ingenol mebutate gel 0.05% for the treatment of external anogenital warts', Journal of the European Academy of Dermatology and Venereology, bind 32, nr. 5, s. 825-831. https://doi.org/10.1111/jdv.14625

APA

Larsen, H. K., Banzhaf, C. A., Thomsen, S. F., Gormsen, M., Schopf, R. E., & Haedersdal, M. (2018). An exploratory, prospective, open-label trial of ingenol mebutate gel 0.05% for the treatment of external anogenital warts. Journal of the European Academy of Dermatology and Venereology, 32(5), 825-831. https://doi.org/10.1111/jdv.14625

Vancouver

Larsen HK, Banzhaf CA, Thomsen SF, Gormsen M, Schopf RE, Haedersdal M. An exploratory, prospective, open-label trial of ingenol mebutate gel 0.05% for the treatment of external anogenital warts. Journal of the European Academy of Dermatology and Venereology. 2018;32(5):825-831. https://doi.org/10.1111/jdv.14625

Author

Larsen, H K ; Banzhaf, C A ; Thomsen, S F ; Gormsen, M ; Schopf, R E ; Haedersdal, M. / An exploratory, prospective, open-label trial of ingenol mebutate gel 0.05% for the treatment of external anogenital warts. I: Journal of the European Academy of Dermatology and Venereology. 2018 ; Bind 32, Nr. 5. s. 825-831.

Bibtex

@article{c75f1f7687fc4313965620838e5384a1,
title = "An exploratory, prospective, open-label trial of ingenol mebutate gel 0.05{\%} for the treatment of external anogenital warts",
abstract = "BACKGROUND: Anogenital warts (AGW) can cause physical discomfort and decreased quality of life. Recent case reports suggest that ingenol mebutate gel might be an effective treatment of AGW.OBJECTIVE: To explore primarily the safety, and secondarily the efficacy of ingenol mebutate gel 0.05{\%} in patients with AGW.METHODS: This was an exploratory, open-label, 1-arm trial of ingenol mebutate gel 0.05{\%} administered up to three times to patients with AGW. Safety was assessed by occurrence and severity of local skin reactions (LSRs) and treatment-related adverse events (AEs). Efficacy was assessed by complete clearance and reduction in AGW count 14 days after last treatment, and recurrence 12 weeks after clearance.RESULTS: Of 41 patients enrolled, 40 received treatment and 26 completed the trial. Patients had a median AGW count of 11.0 and AGW duration of 3.0 years at baseline. All patients experienced transient LSRs following treatment with a maximum composite LSR score of 7.5 (on a scale from 0 to 18). A total of 93{\%} of patients reported treatment-related AEs, most frequently pain (85{\%}) and procedural complications (35{\%}) due to smearing of the gel. 78{\%} of patients took mild analgesics for the pain, typically for 1-2 days following treatment. The majority of AEs were of moderate-to-severe intensity. Seventeen of 39 patients (43.6{\%}) had complete clearance 14 days after last treatment, and AGW count was reduced by 90.9{\%}. There was a tendency towards lower clearance rate in patients with longer duration of AGW. Eight of 14 patients (57.1{\%}) had AGW recurrence 12 weeks after clearance.CONCLUSION: Ingenol mebutate gel was associated with a high number of AEs and withdrawals due to painful local and adjacent skin reactions. Furthermore, it showed promising efficacy in reducing AGW despite a difficult-to-treat population. Optimization of the formulation is warranted to improve the safety profile of the treatment.",
keywords = "Journal Article",
author = "Larsen, {H K} and Banzhaf, {C A} and Thomsen, {S F} and M Gormsen and Schopf, {R E} and M Haedersdal",
note = "{\circledC} 2017 European Academy of Dermatology and Venereology.",
year = "2018",
doi = "10.1111/jdv.14625",
language = "English",
volume = "32",
pages = "825--831",
journal = "Journal of the European Academy of Dermatology and Venereology",
issn = "0926-9959",
publisher = "Elsevier",
number = "5",

}

RIS

TY - JOUR

T1 - An exploratory, prospective, open-label trial of ingenol mebutate gel 0.05% for the treatment of external anogenital warts

AU - Larsen, H K

AU - Banzhaf, C A

AU - Thomsen, S F

AU - Gormsen, M

AU - Schopf, R E

AU - Haedersdal, M

N1 - © 2017 European Academy of Dermatology and Venereology.

PY - 2018

Y1 - 2018

N2 - BACKGROUND: Anogenital warts (AGW) can cause physical discomfort and decreased quality of life. Recent case reports suggest that ingenol mebutate gel might be an effective treatment of AGW.OBJECTIVE: To explore primarily the safety, and secondarily the efficacy of ingenol mebutate gel 0.05% in patients with AGW.METHODS: This was an exploratory, open-label, 1-arm trial of ingenol mebutate gel 0.05% administered up to three times to patients with AGW. Safety was assessed by occurrence and severity of local skin reactions (LSRs) and treatment-related adverse events (AEs). Efficacy was assessed by complete clearance and reduction in AGW count 14 days after last treatment, and recurrence 12 weeks after clearance.RESULTS: Of 41 patients enrolled, 40 received treatment and 26 completed the trial. Patients had a median AGW count of 11.0 and AGW duration of 3.0 years at baseline. All patients experienced transient LSRs following treatment with a maximum composite LSR score of 7.5 (on a scale from 0 to 18). A total of 93% of patients reported treatment-related AEs, most frequently pain (85%) and procedural complications (35%) due to smearing of the gel. 78% of patients took mild analgesics for the pain, typically for 1-2 days following treatment. The majority of AEs were of moderate-to-severe intensity. Seventeen of 39 patients (43.6%) had complete clearance 14 days after last treatment, and AGW count was reduced by 90.9%. There was a tendency towards lower clearance rate in patients with longer duration of AGW. Eight of 14 patients (57.1%) had AGW recurrence 12 weeks after clearance.CONCLUSION: Ingenol mebutate gel was associated with a high number of AEs and withdrawals due to painful local and adjacent skin reactions. Furthermore, it showed promising efficacy in reducing AGW despite a difficult-to-treat population. Optimization of the formulation is warranted to improve the safety profile of the treatment.

AB - BACKGROUND: Anogenital warts (AGW) can cause physical discomfort and decreased quality of life. Recent case reports suggest that ingenol mebutate gel might be an effective treatment of AGW.OBJECTIVE: To explore primarily the safety, and secondarily the efficacy of ingenol mebutate gel 0.05% in patients with AGW.METHODS: This was an exploratory, open-label, 1-arm trial of ingenol mebutate gel 0.05% administered up to three times to patients with AGW. Safety was assessed by occurrence and severity of local skin reactions (LSRs) and treatment-related adverse events (AEs). Efficacy was assessed by complete clearance and reduction in AGW count 14 days after last treatment, and recurrence 12 weeks after clearance.RESULTS: Of 41 patients enrolled, 40 received treatment and 26 completed the trial. Patients had a median AGW count of 11.0 and AGW duration of 3.0 years at baseline. All patients experienced transient LSRs following treatment with a maximum composite LSR score of 7.5 (on a scale from 0 to 18). A total of 93% of patients reported treatment-related AEs, most frequently pain (85%) and procedural complications (35%) due to smearing of the gel. 78% of patients took mild analgesics for the pain, typically for 1-2 days following treatment. The majority of AEs were of moderate-to-severe intensity. Seventeen of 39 patients (43.6%) had complete clearance 14 days after last treatment, and AGW count was reduced by 90.9%. There was a tendency towards lower clearance rate in patients with longer duration of AGW. Eight of 14 patients (57.1%) had AGW recurrence 12 weeks after clearance.CONCLUSION: Ingenol mebutate gel was associated with a high number of AEs and withdrawals due to painful local and adjacent skin reactions. Furthermore, it showed promising efficacy in reducing AGW despite a difficult-to-treat population. Optimization of the formulation is warranted to improve the safety profile of the treatment.

KW - Journal Article

U2 - 10.1111/jdv.14625

DO - 10.1111/jdv.14625

M3 - Journal article

VL - 32

SP - 825

EP - 831

JO - Journal of the European Academy of Dermatology and Venereology

JF - Journal of the European Academy of Dermatology and Venereology

SN - 0926-9959

IS - 5

ER -

ID: 189663901