Phase 2
Completed N=220
Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis
Source: ClinicalTrials.gov NCT02100813 ↗Enrolled (actual)
220
Serious AEs
2.3%
Results posted
Feb 2019
Primary outcomePrimary: Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT) — 0; 0; 0; 0 Participants
Summary
To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate 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: Number of Participants Experiencing a Dose-limiting Toxicity (DLT) |
0; 0; 0; 0; 0; 10 | — |
| PRIMARY Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Lesion Count |
12.6; 72.7; 78.5 | <0.001 sig |
| SECONDARY Part 2: Participants With Complete Clearance of AKs |
3.1; 21.9; 29.9 | =0.007 sig |
| SECONDARY Part 2: Participants With Partial Clearance of AKs |
6.3; 54.7; 59.7 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp.
- Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp
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 (NCT02100813). 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.