Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Ingenol mebutate gel 0.05%

Martina Ulrich

The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard.

Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%

The primary response criterion is the clinical and histological clearance of AK at Day 57. Clinical Clearance will be measured by counting AKs, and histological clearance will be by performing a biopsy (result reported as AK or not AK).

Efficacy in terms of complete clearance of AKs in the STA and histological clearance of pre-identified lesion. AK clearance will be determined by AK count. Clearance of the pre-identified lesion will be assessed by a histopatholgist from a biopsy sample and reported as AK or not AK.

LEO Pharma

Application of AVX001 1% gel to treatment field once daily

Application of AVX001 3% gel to treatment field once daily.

Application of AVX001 vehicle gel to treatment field once daily

Topical gel treatment for once daily application

AVX001

Merete Haedersdal, MD, PhD

Actinic keratosis (AK), also known as solar keratosis, is a common skin condition characterised by abnormal growth of skin cells caused by long-term sun exposure. AK is considered to be a precancerous lesion, and is therefore commonly treated to reduce the risk of malignant transformation into skin cancer.

The trial is a randomised, double-blind, vehicle-controlled, dose-comparison trial in which adult subjects with AK grade 1 or 2 will be treated with AVX001 silicone-based gel in doses of 1% or 3% or with a gel vehicle for a 4-week field-directed treatment period. Subjects will be followed up for 8 weeks after the treatment period. The primary objective is to evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle.

Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK

A Single-center, Randomized Double-blind, Vehicle-controlled, Dose-ranging Decentralised Clinical Trial to Evaluate the Safety and Efficacy of Daily Field-directed Topical Applications of AVX001 Silicone-based Gel in Doses of 1% or 3% in Adult Subjects With Multiple Actinic Keratosis Lesions Olsen Grade 1 or 2

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%	NCT01892137	Actinic Keratos...	Ingenol mebutat...	18 Years -	LEO Pharma
Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK	NCT05164393	Actinic Keratos...	AVX001	18 Years -	Coegin Pharma AB

Spots Global Cancer Trial Database for local skin reaction