Ingenolmebutate

Substance that occurs in garden spurge and is a member of the chemical group of diterpenes (terpenes). Ingenolmebutate is used as a medicinal substance in gel form for the topical treatment of actinic keratoses. Ingenolmebutate belongs to the esters of a group of diterpenes (Ingenane, Tigliane, Daphnane),.

On the one hand, the active substance proves to be cytotoxic, on the other hand the substance initiates a neutrophil-mediated immune reaction. The substance stimulates the protein kinase-C-dependent cytokine release (IL-8 and TNF-alpha).

• Short-term therapy for the facial area: 1x/day application of the 0.015% gel, duration: 3 days.
• For extremities and trunk the higher dosed 0.05% gel is applied 1x/day for 2 days.

Trade name: ^Picato®

Red Hand Letter on Picato (ingenol mebutate) - January 2020

27.01.2020 - With this Red Hand Letter, the manufacturer informs about the suspension of the marketing authorization of Picato (ingenol mebutate) due to the risk of malignant skin lesions.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA ) has completed its review of Picato® with the conclusion that the medicine may increase the risk of skin cancer and that the risks outweigh the benefits.

A gel containing ingenolmebutate has been approved in the USA since January 2012 and in the EU countries since November 2012.

In 2020, the approval was revoked because an increased risk of skin cancer was observed during treatment.

In Australian folk medicine, the effectiveness of the juice of the garden spurge on warts and "skin tumors" is known.

Experimental: Successful treatments for condylomata acuminata have been reported (single dabbing of the papillomas with the ingenolmebutate gel Picato).

1. Gellrich FF et al (2014) Ingenolmebutat for the treatment of actinic keratosis in routine outpatient care. Act Dermatol 40: 340-346
2. Farewell M et al (2012) Ingenol mebutate gel for actinic keratosis. N Engl J Med 366:1010-1019
3. Braun SA et al (2015) Successful therapy of condyloma acuminata with ingenolmebutate. Dermatologist 66: 223-225