A Trial to Compare the Incidence of SCC and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp

Status:	Terminated
Conditions:	Cancer, Dermatology
Therapuetic Areas:	Dermatology / Plastic Surgery, Oncology
Healthy:	No
Age Range:	Any
Updated:	6/17/2018
Start Date:	June 16, 2017
End Date:	February 7, 2018

Incidence of Squamous Cell Carcinoma and Other Skin Neoplasia in Subjects With Actinic Keratosis Treated With Ingenol Disoxate Gel 0.018% or 0.037%, or Vehicle

One of the main reasons for treating AK is the wish to lower the risk of progression of AK to
SCC. This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk,
but since patients can have dozens of AKs and the disease is chronic the cumulative risk for
a patient can be substantial.

In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the
incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients
over a period of 2 years, so that the total follow-up time for each patient will be 3 years
and 2 months.

Inclusion Criteria:

- Signed and dated informed consent has been obtained.

- The subject has been treated in one of the trials LP0084-1193, -1194, -1195, or -1196
and has been evaluated at the end of follow-up visit (month 14) of that trial.

Exclusion Criteria:

- The subject is in need of treatment with ingenol mebutate or ingenol disoxate in the
selected treatment area .

- The subject is enrolled in any other interventional clinical trial.

For subjects where there is a gap between end of follow-up visit (month 14) in one of the
trials LP0084-1193, -1194, -1195, or -1196 and participation in the current trial:

- The subject has been treated with ingenol mebutate or ingenol disoxate in the selected
treatment area after end of follow-up visit (month 14) in one of the trials
LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.

- The subject has been enrolled in any other interventional clinical trial after end of
follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196
and until participation in the current trial.

We found this trial at

sites

Clarkston Skin Research

Clarkston, Michigan 48346

1950

from 91732

Clarkston, MI