application on1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 3 consecutive days.

Lentigo Maligna

apply on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 3 consecutive days.

Picato gel

AP-HP Hopital Avicenne

AP-HP Hôpital Ambroise Paré

Hôpital du Morvan

CHRU de Lille

CHU de Nantes

CHU de Nice

Hôpital Pontchaillou

CHU de Saint Etienne

Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face

Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face - Study PICAMEL

calculated from the date of the CR and the date of relapse or death related to the non-invasive LM (very unlikely here). Relapse is defined as the clinical appearance of a new pigmented lesion with histopathological analysis, from one or more biopsy (s), which confirms the diagnosis of non-invasive LM.

• The type, frequency, severity and the time to onset of side effects will be reported. The side effects will be classified into grades according to WHO criteria and also using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The intensity of short-term local side effects will be evaluated by the Local Skin Reaction score

Centre Hospitalier Universitaire de Nice

At Visit 1, ingenol mebutate 0.015% alone on the second 25 cm2 treatment area. The treatment area receiving ingenol mebutate 0.015% alone will apply the medication as directed per approved drug labeling. Patients will apply ingenol mebutate gel on Day 2 and Day 3.

At Visit 1, ingenol mebutate 0.015% and dermasil lotion on one 25 cm2 treatment area. The treatment area receiving both ingenol mebutate 0.015% and dermasil lotion, will first apply ingenol mebutate 0.015% allow the gel to dry completely as per drug labeling on Day 1. The patient will allow at least 6 hours between the application of ingenol mebutate and dermasil lotion on Day 2 and 3. Patients will apply dermasil lotion daily on Day 2 until at least Day 8. At Day 8, the physician will reassess whether dermasil application should be continued to Day 15 or ceased. At Day 15, the physician will reassess whether dermasil application should be continued to Day 29 or ceased.

Actinic Keratoses

one cycle of ingenol mebutate 0.015% on two 25 cm2 treatment areas

ingenol mebutate 0.015%

Dermasil lotion has 1% dimethicone as its active ingredient - part of the family of silicone oils, is a hypoallergenic, noncomedogenic, and nonacnegenic agent

dermasil lotion

Icahn School of Medicine at Mount Sinai

Treatment of Actinic Keratoses (AK) on the Face

An Investigator-Initiated Study to Assess the Efficacy and Degree of Irritation of Ingenol Mebutate 0.015% Gel and Dermasil Lotion Versus Ingenol Mebuate 0.015% Alone in the Treatment of Actinic Keratoses (AK) on the Face.

Investigator assessment of the degree of irritation as measured by local skin reactions at day 57 as compared to baseline.

Change in the number of AK lesions at 57 days as compared to baseline to assess AK clearance

The patient pruritus VAS survey to assess patient treatment satisfaction.

Mark Lebwohl

Professor and System Chair Dermatology

LEO Pharma

Actinic Keratosis

Ingenol Mebutate 0.015%

Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp

An Investigator-Initiated Study to Assess the Degree of Irritation After a Second Cycle of Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp

To evaluate the degree of irritation, as measured by local skin reactions (LSR), after a second cycle of ingenol mebutate gel to the face or scalp through photography assessed by a blinded observer.

To evaluate and compare the degree of irritation, as measured by LSR, that occurs one (1) day post-application of the first and second cycle of ingenol mebutate gel to the face or scalp.

euphorbia cuneifolia/iekaisums

Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face

Treatment of Actinic Keratoses (AK) on the Face

Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp

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