Phase 3
Completed N=729
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
Source: ClinicalTrials.gov NCT02361216 ↗Enrolled (actual)
729
Serious AEs
1.4%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Participants With Complete Resolution of Actinic Keratosis (AK) — 21.4; 3.4 percentage of participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Resolution of Actinic Keratosis (AK) |
21.4; 3.4 | <0.001 sig |
| SECONDARY Percentage of Participants With Partial Clearance at Week 8 |
59.4; 8.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Partial Clearance at Week 4 |
59.8; 9.2 | <0.001 sig |
| SECONDARY Percent Reduction From Baseline in AK Count |
75.7; 12.7 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:
- The full face
- The full balding scalp
- A contiguous area of approximately 250 cm2 on the chest
Exclusion Criteria
- Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
- Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
- Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months.
- Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
Data sourced from ClinicalTrials.gov (NCT02361216). 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.