Phase 2
Completed 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
Source: ClinicalTrials.gov NCT02120456 ↗Enrolled (actual)
69
Serious AEs
1.3%
Results posted
Jan 2019
Primary outcomePrimary: Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs) — 0; 0; 2; 1 Participants
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
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 |
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. Informational only — not medical advice.