Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Chiari Malformation Type 2

ingenol mebutate

Placebo

Daniel M Siegel, MD, MS

This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel

Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

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

The table presents the mean across 1000 multiple imputations. Missing values for AK count were imputed sequentially from a negative binomial regression model with treatment group, AK counts at the previous visit, and analysis site as covariates and log baseline AK count as offset.

The number of clinically visible AK lesions identified in the treatment area was to be recorded at Visit 1(≤14 days prior to Day 1).

The analysis was based on 1000 imputations of actinic keratosis lesion count at Week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline actinic keratosis lesion count as offset. The table shows the adjusted percentage reduction from baseline.

Values for the Ingenol 4 days arm were calculated separately based on observed cases. On the basis of the data monitoring committee's recommendation the 4-day active treatment group was closed, and this arm was excluded from statistical models and comparisons in the secondary efficacy analyses.

Partial clearance of AKs at Week 8, defined as at least 75% reduction from baseline in number of AKs, was analysed in the same way as the primary response criterion.

The percent reduction at Week 8 from baseline was analyzed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values).

The table presents the mean across 1000 multiple imputations. Missing values for AK count were imputed sequentially from a negative binomial regression model with treatment group, AK counts at the previous visit, and analysis site as covariates and log baseline AK count as offset.

LEO Pharma

2 days treatment with ingenol mebutate 0.06% gel and 2 days treatment with vehicle gel

Ingenol 2 Days

1 day treatment with vehicle gel and 3 days treatment with ingenol mebutate 0.06% gel

Ingenol 3 Days

4 days treatment with ingenol mebutate 0.06% gel

Ingenol 4 Days

Vehicle

3 days treatment with ingenol mebutate 0.06% gel and 1 day treatment with vehicle gel

Total

Age, Continuous

Sex: Female, Male

United States

Australia

Region of Enrollment

Clinical Trial Disclosure Manager

Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.

Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared participant in the vehicle group.

Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.

Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared subject in the vehicle group.

Type I error not controlled.

Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.

Type I error not controlled. Mantel-Haenszel estimators were used.

The analysis was based on the Full Analysis Set, which was defined as all randomized participants.

Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs)

Percentage of Reduction in Actinic Keratosis (AK) Lesion Count From Baseline (Day 1) (Multiple Imputation)

The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.

Percentage of Participants With Partial Clearance of AKs

Ingenol mebutate gel 0.06% and vehicle gel applied topically once daily to a contiguous area of approximately 250 cm2 sun-damaged skin on trunk (except chest), or extremities (arm with or without back of hand, or leg). Vehicle gel was applied for 2 days and ingenol mebutate gel 0.06% was applied for 2 days for a total 4 consecutive days.

Ingenol mebutate gel 0.06% and vehicle gel applied topically once daily to a contiguous area of approximately 250 cm2 sun-damaged skin on trunk (except chest), or extremities (arm with or without back of hand, or leg). Vehicle gel was applied for 1 day and ingenol mebutate gel 0.06% was applied for 3 days for a total 4 consecutive days.

Ingenol mebutate gel 0.06% applied topically once daily to a contiguous area of approximately 250 cm2 sun-damaged skin on trunk (except chest), or extremities (arm with or without back of hand, or leg) for 4 consecutive days.

Vehicle gel applied topically once daily to a contiguous area of approximately 250 cm2 sun-damaged skin on trunk (except chest), or extremities (arm with or without back of hand, or leg) for 4 consecutive days.

Spots Global Cancer Trial Database for Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

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