PMID- 29024025
OWN - NLM
STAT- MEDLINE
DCOM- 20181016
LR  - 20181016
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Linking)
VI  - 32
IP  - 5
DP  - 2018 May
TI  - An exploratory, prospective, open-label trial of ingenol mebutate gel 0.05% for 
      the treatment of external anogenital warts.
PG  - 825-831
LID - 10.1111/jdv.14625 [doi]
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.
CI  - (c) 2017 European Academy of Dermatology and Venereology.
FAU - Larsen, H K
AU  - Larsen HK
AD  - Department of Dermato-Venereology, University Hospital of Copenhagen, Bispebjerg 
      Hospital, Copenhagen, Denmark.
FAU - Banzhaf, C A
AU  - Banzhaf CA
AD  - Department of Dermato-Venereology, University Hospital of Copenhagen, Bispebjerg 
      Hospital, Copenhagen, Denmark.
FAU - Thomsen, S F
AU  - Thomsen SF
AD  - Department of Dermato-Venereology, University Hospital of Copenhagen, Bispebjerg 
      Hospital, Copenhagen, Denmark.
AD  - Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.
FAU - Gormsen, M
AU  - Gormsen M
AD  - LEO Pharma A/S, Ballerup, Denmark.
FAU - Schopf, R E
AU  - Schopf RE
AD  - Department of Dermatology, Johannes Gutenberg University, Mainz, Germany.
FAU - Haedersdal, M
AU  - Haedersdal M
AD  - Department of Dermato-Venereology, University Hospital of Copenhagen, Bispebjerg 
      Hospital, Copenhagen, Denmark.
LA  - eng
PT  - Journal Article
DEP - 20180123
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (3-ingenyl angelate)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Diterpenes)
RN  - 0 (Gels)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*adverse effects/therapeutic use
MH  - Anus Diseases/*drug therapy
MH  - Blister/chemically induced
MH  - Condylomata Acuminata/*drug therapy
MH  - Diterpenes/*adverse effects/therapeutic use
MH  - Edema/chemically induced
MH  - Erythema/chemically induced
MH  - Female
MH  - Gels
MH  - Genital Diseases, Female/*drug therapy
MH  - Genital Diseases, Male/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain/chemically induced
MH  - Prospective Studies
MH  - Recurrence
MH  - Skin Ulcer/chemically induced
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2017/10/13 06:00
MHDA- 2018/10/17 06:00
CRDT- 2017/10/13 06:00
PHST- 2017/06/12 00:00 [received]
PHST- 2017/09/20 00:00 [accepted]
PHST- 2017/10/13 06:00 [pubmed]
PHST- 2018/10/17 06:00 [medline]
PHST- 2017/10/13 06:00 [entrez]
AID - 10.1111/jdv.14625 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2018 May;32(5):825-831. doi: 10.1111/jdv.14625. 
      Epub 2018 Jan 23.