Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Chiari Malformation Type 2

Open-label, dose-escalation, 2-day treatment

LEO 43204 dose 0.1% once daily for two consecutive days

LEO 43204 dose 0.075% once daily for two days

LEO 43204

Placebo

Gary Goldenberg, MD

Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT.

A DLT was defined as one or more of the following three LSRs:

* Crusting Grade 4
* Erosion/Ulceration Grade 4
* Vesiculation/Pustulation Grade 4

or two or more of the following five LSRs:

* Crusting Grade 3
* Swelling Grade 4
* Erosion/Ulceration Grade 3
* Vesiculation/Pustulation Grade 3

or other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT.

The LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.

Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.

Complete clearance was defined as a 100% reduction from baseline in AK count.

Partial clearance was defined as at least 75% reduction from baseline in AK count.

LEO Pharma

Once daily treatment for two consecutive days with LEO 43204 gel 0.018%

Part 1: LEO 43204 Gel 0.018%

Once daily treatment for two consecutive days with LEO 43204 gel 0.025%

Part 1: LEO 43204 Gel 0.025%

Once daily treatment for two consecutive days with LEO 43204 gel 0.037%

Part 1: LEO 43204 Gel 0.037%

Once daily treatment for two consecutive days with LEO 43204 gel 0.05%

Part 1: LEO 43204 Gel 0.05%

Once daily treatment for two consecutive days with LEO 43204 gel 0.075%

Part 1: LEO 43204 Gel 0.075%

Once daily treatment for two consecutive days with LEO 43204 gel 0.1%

Part 1: LEO 43204 Gel 0.1%

Once daily treatment for two consecutive days LEO 43204 vehicle gel

Part 2: LEO 43204 Vehicle Gel

Once daily treatment for two consecutive days LEO 43204 gel 0.075%

Part 2: LEO 43204 Gel 0.075%

Once daily treatment for two consecutive days LEO 43204 gel 0.1%

Part 2: LEO 43204 Gel 0.1%

Total

Age, Categorical

Sex: Female, Male

Canada

United States

Region of Enrollment

Clinical Trial Disclosure Specialist

Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)

Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.

Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count

Log binomial regression with factors treatment group and baseline AK count as a covariate.

Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])

Part 2: Participants With Partial Clearance of AKs (LOCF)

Once daily treatment for two consecutive days with LEO 43204 gel 0.018% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.

Once daily treatment for two consecutive days with LEO 43204 gel 0.025% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.

Once daily treatment for two consecutive days with LEO 43204 gel 0.037% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.

Once daily treatment for two consecutive days with LEO 43204 gel 0.05% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.

Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.

Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.

Once daily treatment for two consecutive days with LEO 43204 vehicle gel on sun exposed area of 250 cm2 on the extremities or trunk (except chest).

Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).

Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).

Spots Global Cancer Trial Database for Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial