New product update

A round-up of the latest developments in pharmaceuticals, clinical studies and guidance, as reported in MIMS

Actinic keratosis: new topical gel offers more rapid treatment (Photograph: Girand/SPL)
Actinic keratosis: new topical gel offers more rapid treatment (Photograph: Girand/SPL)

Novel AK treatment

Picato (ingenol mebutate) is a topical gel from Leo Pharma indicated for the treatment of non-hyperkeratotic and non-hypertrophic actinic keratosis (AK). It is applied once daily for two or three consecutive days, in contrast to other treatments that are generally used for weeks or months.

Ingenol mebutate is derived from the Euphorbia peplus plant and is thought to act by inducing local lesion cell death and promoting an inflammatory response.1

Clinical studies

The safety and efficacy of ingenol mebutate were assessed in four double-blind, vehicle-controlled studies involving patients with four to eight AK lesions.

In the first two studies, 547 patients were randomised to receive ingenol mebutate 150 microgram/g or vehicle applied to lesions on the face or scalp for three consecutive days. In the second two studies, 458 patients received ingenol mebutate 500 microgram/g or vehicle applied to lesions on the trunk and extremities for two consecutive days.1

Efficacy endpoints were complete clearance rate (defined as the proportion of patients with no clinically visible AK lesions in the treatment area) and partial clearance rate (defined as the proportion of patients with a reduction of 75% or more from baseline in the number of AK lesions).1

At day 57, patients treated with ingenol mebutate had significantly higher complete and partial clearance rates than those treated with vehicle (p<0.001). Patients receiving ingenol mebutate also had significantly higher scores on the Treatment Satisfaction Questionnaire for Medication, indicating a higher level of overall satisfaction than those receiving vehicle (p<0.001).1

Patients who achieved complete clearance with ingenol mebutate at day 57 entered a 12-month follow-up period (face/scalp, n = 108; trunk/extremities, n = 76). At 12 months, the recurrence rate was 53.9% in patients with face or scalp lesions and 56% in patients with lesions on the trunk or extremities.1

The most common adverse effects that were observed with ingenol mebutate were headache, eyelid and periorbital oedema and local skin reactions, including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration.1

New anaesthetic cream

Galderma has launched a new local anaesthetic combination cream, Pliaglis (lidocaine/tetracaine), for surface anaesthesia of skin before dermatological procedures.

Clinical studies

The safety and efficacy of the lidocaine/tetracaine combination were evaluated in 12 randomised, double-blind phase III studies (n = 669) involving various dermatological procedures and application times.2

Lidocaine/tetracaine and placebo were applied to two comparable areas of skin with pretreatment contact times of 20 minutes for pulsed dye laser therapy, 30 minutes for dermal filler and collagen injections, laser-assisted hair removal and non-ablative laser resurfacing, and 60 minutes for laser-assisted tattoo removal and leg vein ablation.2

Pain was measured using a 100mm visual analogue scale. Treatment with lidocaine/tetracaine resulted in a significant reduction in pain compared with placebo in all instances.2

The lidocaine/tetracaine combination was well tolerated, with erythema, skin discoloration and skin oedema the most common adverse effects.2

NICE approves two treatments for patients with melanoma

Vemurafenib and ipilimumab have been approved for NHS use in patients with specific types of melanoma, on the proviso that the manufacturers of the drugs supply them with the discount agreed in the patient access scheme.3,4

First-line oral treatment

Vemurafenib (Zelboraf) is an oral protein kinase inhibitor indicated as monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

All patients should have their mutation-positive tumour status confirmed by a validated test before commencing treatment. Vemurafenib is available as tablets for twice-daily administration.5

IV infusion for second-line use

Ipilimumab (Yervoy) belongs to the monoclonal antibody class of antineoplastic agents and is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy. Ipilimumab is administered by IV infusion over 90 minutes.6

NICE considers that the introduction of vemurafenib and ipilimumab represents a 'step change' in the treatment of advanced melanoma, with both drugs meeting its criteria for being life-extending end-of-life treatments.3,4


1. Picato Summary of Product Characteristics, November 2012.

2. Pliaglis Summary of Product Characteristics, September 2012.

3. NICE. Vemurafenib for treating locally advanced or metastatic BRAF V600 mutation-positive malignant melanoma. NICE technology appraisal guidance 269. London, NICE, December 2012.

4. NICE. Ipilimumab for previously treated advanced (unresectable or metastatic) melanoma. NICE technology appraisal guidance 268. London, NICE, December 2012.

5. Zelboraf Summary of Product Characteristics, December 2012.

6. Yervoy Summary of Product Characteristics, July 2012.

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