Clinical trial · Interventional
Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm
A Seamless Phase 1/2 Exploratory Multi-centre, Investigator-blind, Dose Escalation Study (Study Part 1), Followed by a Randomised, Intra-subject, Active Controlled Efficacy Study of Different Ingenol Mebutate Formulations Applied to the Forearm for 2 Consecutive Days (Study Part 2)
- 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 purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation) when applied to AK lesions on the forearm for two consecutive days.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| once daily for two consecutive days (Picato) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Picato® 0.05% gel
- description
- once daily for two consecutive days
- interventionNames
- Drug: once daily for two consecutive days (Picato)
- type
- EXPERIMENTAL
- label
- ingenol mebutate vehicle formulation 1
- description
- once daily for two consecutive days
- interventionNames
- Drug: once daily for two consecutive days (Picato)
- type
- EXPERIMENTAL
- label
- ingenol mebutate vehicle formulation 2
- description
- once daily for two consecutive days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be male or female and at least 18 years of age. * Female patients must be of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception. * Ability to provide informed consent. Exclusion Criteria: * location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma * undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit * presence of sunburn within the selected treatment areas * use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit * previous enrolment in this clinical trial * prior treatment with ingenol mebutate on the forearms * use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to the treatment visit * treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of the treatment visit * treatment with 5-FU, imiquimod, diclofenac,or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to the treatment visit * use of systemic retinoids * those who are currently participating in any other clinical trial * females who are pregnant or are breastfeeding * those known or suspected or not being able to comply with the requirements of the protocol or provide consent
References
Publications (0)
Data not yet available