Clinical trial · Interventional
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
NCT02549352CI-TRIAL-00087131completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LEO43204 gel | Drug | — | UNRESOLVED |
| Vehicle gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LEO 43204 gel
- description
- Treatment once daily for 3 days
- interventionNames
- Drug: LEO43204 gel
- type
- PLACEBO_COMPARATOR
- label
- Vehicle gel
- description
- Treatment once daily for 3 days
- interventionNames
- Drug: Vehicle gel
Primary outcomes (1)
- measure
- Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
- timeFrame
- At Week 8
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 (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)
References
Publications (0)
Data not yet available
No reference posted for this study.