Clinical trial · Interventional
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.
NCT01302925CI-TRIAL-00019111completedPhase 1ClinicalTrials.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 purpose of this phase 1 trial is to investigate the local tolerability on the finger following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3 consecutive days.
Conditions
Conditions (2)
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 | — |
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEP005 Gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PEP005 Gel 0.05%/2 days
- description
- Subjects will be exposed to investigational product for 2 consecutive days.
- interventionNames
- Drug: PEP005 Gel
- type
- EXPERIMENTAL
- label
- PEP005 Gel 0.015%/3 days
- description
- Subjects will be exposed to investigational product for 3 consecutive days.
- interventionNames
- Drug: PEP005 Gel
Primary outcomes (1)
- measure
- Local Skin Responses
- timeFrame
- Up to 8 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 have a negative serum and urine pregnancy test and using effective contraception * Ability to provide informed consent Exclusion Criteria: * Have received treatment with immunomodulators, or interferon/interferon inducers or systematic medications that suppress the immune system in the last 4 weeks * Exposed to prescribed systemic (take as tablet, injection etc) or topical (gel, cream, lotion) medication within the last 7 days * Have any signs of skin irritation or damaged skin at or around the dominant index finger * Have worked in an occupation with a high risk of being in contact with irritative material (eg. chemicals, painting) on their hands, especially fingers * Those who are currently participating in any other clinical trial * Those known or suspected of not being able to comply with the requirements of the protocol * Females who are pregnant or are breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.