Phase 3
Completed N=316
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
Source: ClinicalTrials.gov NCT02547363 ↗Enrolled (actual)
316
Serious AEs
1.2%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants With Complete Clearance of Actinic Keratosis (AK) — 25.8; 0.0 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 This can indicate results are unpublished — a known publication-bias signal.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 compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Clearance of Actinic Keratosis (AK) |
25.8; 0.0 | <0.001 sig |
| SECONDARY Percentage of Participants With Partial Clearance of AKs |
57.4; 1.0 | <0.001 sig |
| SECONDARY Percentage of Participants With Partial Clearance of AKs |
57.4; 1.0 | <0.001 sig |
| SECONDARY Percent Reduction in AK Count in the Treatment Area Compared to Baseline |
72.3; -2.0 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
- Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area
Exclusion Criteria
- Location of the treatment area (full balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
- Treatment with ingenol mebutate gel in the treatment area within the last 12 months
- Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
- History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)
Data sourced from ClinicalTrials.gov (NCT02547363). 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.