Phase 2 N=189 Treatment

Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively

Actinic Keratosis

Bottom Line

View on ClinicalTrials.gov: NCT02305888 ↗

Enrolled (actual)

189

Serious AEs

0.5%

Results posted

Mar 2019

Primary outcome: Primary: Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions) — 9; 0; 11 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LEO 43204 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: LEO Pharma
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)	9; 0; 11	—
SECONDARY Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic	81.2; 78.8; 59.0; 78.9; 76.3; 69.1	—
SECONDARY Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic	78.7; 58.1; 36.0; 68.5; 62.5; 39.2	—
SECONDARY Percentage of Participants With Complete Clearance of AKs	36.5; 39.7; 22.6	—

Summary

The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.

Eligibility Criteria

Inclusion Criteria

Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:

The full face
The full balding scalp
A contiguous area of approximately 250 cm2 on trunk or extremities

Exclusion Criteria

Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.

Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.

Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months

Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02305888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.