Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Keratosis, Actinic

Keratosis

Alopecia

Alopecia Areata

Skin Diseases

Precancerous Conditions

LEO43204 gel

Vehicle gel

Rolf-Markus Szeimies, Prof. Dr.med

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), Weeks 4, and 8.

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

The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8.

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

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

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.

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

LEO 43204 0.037% Gel

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

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

Germany

Italy

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.

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