NCT03115476

A Trial to Compare the Incidence of Squamous Cell Carcinoma (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

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 Gel

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 563 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (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.

Conditions

• Actinic Keratosis
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	ingenol disoxate gel 0.018%	Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
DRUG	ingenol disoxate gel 0.037%	Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
OTHER	Vehicle gel	Vehicle to ingenol disoxate gel with no active ingredient

Timeline

• Start date: 2017-06-16
• Primary completion: 2018-03-12
• Completion: 2018-03-12
• First posted: 2017-04-14
• Last updated: 2025-03-11
• Results posted: 2019-06-25

Locations

59 sites across 6 countries: United States, Canada, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study