Clinical trial · Interventional
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
NCT01998984CI-TRIAL-00086952completedPhase 2Results 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)
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
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 |
|---|---|---|---|
| ingenol mebutate | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 2 days placebo and 2 days drug
- description
- Placebo and drug
- interventionNames
- Drug: ingenol mebutate
- Other: Placebo
- type
- EXPERIMENTAL
- label
- 1 day placebo and 3 days drug
- description
- Placebo and drug
- interventionNames
- Drug: ingenol mebutate
- Other: Placebo
- type
- PLACEBO_COMPARATOR
- label
- 4 days placebo
- description
- Placebo
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 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)
References
Publications (0)
Data not yet available
No reference posted for this study.