Phase 2
N=69
Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT02120456 ↗Enrolled (actual)
69
Serious AEs
1.3%
Results posted
Jan 2019
Primary outcome: Primary: Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs) — 0; 0; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LEO 43204 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs) |
0; 0; 2; 1; 1; 0 | — |
| PRIMARY Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count |
32.7; 70.0; 62.2 | <0.001 sig |
| SECONDARY Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF]) |
3; 6; 6 | 0.94 |
| SECONDARY Part 2: Participants With Partial Clearance of AKs (LOCF) |
5; 27; 28 | 0.003 sig |
Summary
Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days
Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle
Eligibility Criteria
Inclusion Criteria
- Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm
- Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk
Exclusion Criteria
- Location of the treatment area
- within 5 cm of an incompletely healed wound
- within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
- Prior treatment with ingenol mebutate gel on the treatment area
- Lesions in the treatment areas that have:
- atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
- recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
Data sourced from ClinicalTrials.gov (NCT02120456). 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.