Clinical trial · Interventional
Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
NCT02406014CI-TRIAL-00086380completedPhase 4ClinicalTrials.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 phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.
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 (AK) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diclofenac sodium gel 3% | Drug | — | UNRESOLVED |
| Ingenol Mebutate Gel, 0.015% | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment Group A
- description
- Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.
- interventionNames
- Drug: Ingenol Mebutate Gel, 0.015%
- type
- ACTIVE_COMPARATOR
- label
- Treatment Group B
- description
- Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.
- interventionNames
- Drug: Diclofenac sodium gel 3%
Primary outcomes (1)
- measure
- Complete clearance of all AKs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures 2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp Exclusion Criteria: 1\. Location of the selected treatment area: * on the periorbital skin * on the perioral skin/around the nostrils * within 5 cm of an incompletely healed wound * within 10 cm of a suspected BCC or SCC or other neoplasia
References
Publications (1)
- DERIVEDStockfleth E, Harwood CA, Serra-Guillen C, Larsson T, Osterdal ML, Skov T. Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0.015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp. Br J Dermatol. 2018 Feb;178(2):433-442. doi: 10.1111/bjd.16048. Epub 2018 Jan 15. PMID 29030864