Phase 3 N=307 Randomized Quadruple-blind Treatment

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

Actinic Keratosis

Bottom Line

View on ClinicalTrials.gov: NCT02547233 ↗

Enrolled (actual)

307

Serious AEs

0.3%

Results posted

Dec 2018

Primary outcome: Primary: Percentage of Participants With Complete Clearance of Actinic Keratosis (AK) — 31.3; 1.0 percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: LEO 43204 gel (Drug); Vehicle gel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: LEO Pharma
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)	31.3; 1.0	<0.001 sig
SECONDARY Percentage of Participants With Partial Clearance (Multiple Imputation)	56.6; 5.5	<0.001 sig
SECONDARY Percentage of Participants With Partial Clearance (Multiple Imputation)	56.6; 5.5	<0.001 sig
SECONDARY Percent Reduction in AK Count in the Treatment Area Compared to Baseline	72.1; 7.3	<0.001 sig

Summary

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.

Eligibility Criteria

Inclusion Criteria

Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest
Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area

Exclusion Criteria

Location of the treatment area (full face or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
Treatment with ingenol mebutate gel in the treatment area within the last 12 months
Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02547233). 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.