Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Keratosis, Actinic

Keratosis

Alopecia

Alopecia Areata

Skin Diseases

Precancerous Conditions

LEO 43204 gel

Vehicle gel

Daniel M Siegel, MD

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Week 4 and Week 8.

Complete clearance was defined as no clinically visible AKs in the treatment area.

Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.

The percent reduction at Week 8 from baseline was analysed 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. The table presents adjusted mean percent reduction at Week 8 from baseline.

LEO Pharma

Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review.

For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.

Treatment once daily for 3 days with LEO 43204 0.037% gel

LEO 43204 0.037% Gel

Treatment once daily for 3 days with vehicle gel

Vehicle Gel

LEO 43204 0.037% Gel - Extended Follow-up

Vehicle Gel - Extended Follow-up

Total

Age, Continuous

Age group

Age, Customized

Sex: Female, Male

Canada

France

United Kingdom

United States

Region of Enrollment

Clinical Trial Disclosure Specialist

Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)

The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.

Percentage of Participants With Partial Clearance of AKs

Percent Reduction in AK Count in the Treatment Area Compared to Baseline

Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.

Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.

3-day Treatment and 8-week Follow-up

12-month Follow-up

Facies

C. William Hanke, MD

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment

Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up

Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up

The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Week 4, and Week 8.

Complete clearance was defined as no clinically visible AKs in the treatment area.

The table shows the percentage of mean number of subjects across imputations with complete clearance.

The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 4, and Week 8.

Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.

The table shows the percentage of mean number of participants across imputations with partial clearance.

The percent reduction at Week 8 from baseline was analysed 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 adjusted mean percent reduction at Week 8 from baseline.

Adverse events presented in the table are investigator-reported terms.

Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review.

For further details on the adjudication outcomes, see link to the full report in section "More information"

Treatment once daily for 3 days LEO 43204 0.018% gel

LEO 43204 0.018% Gel

Treatment once daily for 3 days Vehicle gel

LEO 43204 0.018% Gel - Extended Follow-up

Treatment once daily for 3 days with LEO 43204 0.018% gel

Germany

Spain

Italy

Complete Clearance of Actinic Keratosis (AK)

Percentage of Participants With Partial Clearance (Multiple Imputation)

Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.

Treatment with vehicle gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up	NCT02547363	Actinic Keratos...	LEO 43204 gel Vehicle gel	18 Years -	LEO Pharma
Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up	NCT02549339	Actinic Keratos...	LEO 43204 gel Vehicle gel	18 Years -	LEO Pharma
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up	NCT02547363	Actinic Keratos...	LEO 43204 gel Vehicle gel	18 Years -	LEO Pharma
Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up	NCT02549339	Actinic Keratos...	LEO 43204 gel Vehicle gel	18 Years -	LEO Pharma

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