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

6533b7dcfe1ef96bd1272c4e

RESEARCH PRODUCT

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

M. Gormsen Merete Haedersdal C.a. Banzhaf Simon Francis Thomsen Simon Francis Thomsen Helle Kiellberg Larsen R.e. Schopf

subject

Adult Male Ingenol Mebutate Gel medicine.medical_specialty Population Pain Antineoplastic Agents Dermatology Young Adult 030207 dermatology & venereal diseases 03 medical and health sciences Blister 0302 clinical medicine Quality of life Recurrence Internal medicine Skin Ulcer medicine Edema Humans Effective treatment In patient Prospective Studies 030212 general & internal medicine Adverse effect education Aged Anus Diseases education.field_of_study business.industry Middle Aged Safety profile Treatment Outcome Infectious Diseases Condylomata Acuminata Erythema Female Diterpenes Genital Diseases Male Open label business Gels Genital Diseases Female

description

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.

year	journal	country	edition	language
2017-06-12	Journal of the European Academy of Dermatology and Venereology

https://doi.org/10.1111/jdv.14625