All patients will be treated with ingenol mebutate gel 0.015%. There is no placebo or comparator for this study. The investigator will identify the patient's treatment area at Baseline, and provide a detailed application instruction sheet. The first dose will be applied in clinic under the supervision of the investigator.

All patients will be treated with ingenol mebutate gel 0.015%. There is no placebo or comparator for this study. The investigator will identify the patient's treatment area at Baseline, and provide a detailed application instruction sheet. The first dose will be applied in clinic under the supervision of the investigator.
ingenol mebutate gel 0.015%: ingenol mebutate gel 0.015% to be applied on treatment area

Open Label Treatment

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Organ Transplant Type

Years Since Transplant

To evaluate the safety of ingenol mebutate gel 0.015% on the face in solid organ transplant recipients

A total of 20 solid organ transplant recipients with 4 to 20 actinic keratoses were enrolled and treated for 3 consecutive days with 4 single-dose tubes of ingenol mebutate gel 0.015% applied to a 100 cm2 area of the face according to study protocol. There was no placebo or comparator for this study. All but 2 participants completed the treatment. One kidney transplant participant forgot to apply the treatment on day 3, but continued in the study. One lung transplant participant who reported pain in the treatment area withdrew from the study after day 2 dosing due to travel considerations and was lost to follow-up.

Number of Participants With Adverse Events

To evaluate the efficacy of ingenol mebutate for reduction of actinic keratoses on the face in organ transplant recipients.

Number of Participants With a Reduction of Actinic Keratosis

To investigate the local skin response to ingenol mebutate in organ transplant recipients. Local skin reaction (LSR) will be graded by visual assessment on a 4 point scale where 0=none, 1=mild, 2=moderate, 3=severe. Each of the following four reactions will be graded: erythema, vesiculation/postulation, crusting/scabbing/erosion, and edema/swelling. A composite score will be calculated (range 0-16). A high LSR indicated a worse outcome. LSR assessment will be performed at days 1, 8, 29, and 84.

Participant's Local Skin Response Grading Scale

Overall Study

Dr. Sarah Arron, MD, PhD

Actinic Keratosis

ingenol mebutate gel 0.015% to be applied on treatment area

ingenol mebutate gel 0.015%

UCSF Dermatology

Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients

Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of Actinic Keratosis on the Face in Solid Organ Transplant Recipients

Individual participant data may be shared with authorized representatives of the study sponsor LEO Pharma, Inc., The University of California, FDA

Sarah Arron

Principal Investigator & Associate Professor of Dermatology in Residence

University of California, San Francisco

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

euphorbia/krebs

Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients

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

Treatment of Actinic Keratoses (AK) on the Face

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