Phase 2
Completed N=224
Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Source: ClinicalTrials.gov NCT01998984 ↗Enrolled (actual)
224
Serious AEs
5.4%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) — 12.7; 5.1; 26.8; 0.0 percentage of participants — p=0.18
Summary
This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) |
12.7; 5.1; 26.8; 0.0 | 0.18 |
| SECONDARY Percentage of Reduction in Actinic Keratosis (AK) Lesion Count From Baseline (Day 1) (Multiple Imputation) |
64.5; 68.3; 73.6; 11.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Partial Clearance of AKs |
47.3; 56.2; 60.4; 2.0 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities
Exclusion Criteria
- Location of the treatment area (trunk (except chest) or extremities)
- 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 within the selected treatment area
- Lesions in the treatment area 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 (NCT01998984). 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.