Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Keratosis, Actinic

Keratosis

Alopecia

Alopecia Areata

Skin Diseases

Precancerous Conditions

Open-label, dose escalation, 2 days treatment

LEO 43204

Placebo

Jonathan Weiss, MD

To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

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

A DLT was defined as:

* Erosion/ulceration Grade 4 on the Local Skin Response (LSR) scale
* Other clinically relevant signs or symptoms observed, which the International Co-ordinating Investigator judges to be counted as a DLT.

The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are 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) in the selected treatment area.

Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in AK count.

Partial clearance of AKs at Week 8 was defined as at least 75% reduction from baseline in AK count.

LEO Pharma

Part 1 - Dose escalation

Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp.

Part 1 - 0.018% Cohort

Part 1 - Dose escalation

Once daily application with LEO 43204 gel 0.025%for two consecutive days on balding scalp.

Part 1 - 0.025% Cohort

Part 1 - Dose escalation

Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp.

Part 1 - 0.037% Cohort

Part 1 - Dose escalation

Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.

Part 1 - 0.05% Cohort

Part 1 - Dose escalation

Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp.

Part 1 - 0.075% Cohort

Part 2 - Dose finding

Once daily application with LEO 43204 gel vehicle for two consecutive days on balding scalp.

Part 2 - Vehicle

Part 2 - Dose finding

Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp.

Part 2 - 0.037%

Part 2 - Dose finding

Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.

Part 2 - 0.05%

Part 1 - Dose escalation

Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp.

Part 1 - Dose escalation

Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp.

Total

Age, Categorical

Sex: Female, Male

United States

Germany

Region of Enrollment

Clinical Trial Disclosure Specialist

Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)

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) Lesion Count

Log binomial regression with treatment group as factor and baseline AK count included as covariate.

Part 2: Participants With Complete Clearance of AKs

Part 2: Participants With Partial Clearance of AKs

Part 1 - Dose escalation

Once daily application with LEO 43204 gel (ingenol disoxate) 0.018% for two consecutive days on balding scalp.

Spots Global Cancer Trial Database for Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

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