Clinical trial · Interventional
PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities
A Phase 2 Multi-centre, Parallel Group, Open Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Administered for up to Three Consecutive Days to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk or Extremities
- 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 study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.
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 |
|---|---|---|---|
| Superficial Basal Cell Carcinoma | Superficial Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aluminium disk | Device | — | UNRESOLVED |
| OpSite(TM) disk | Device | — | UNRESOLVED |
| PEP005 (ingenol mebutate) Gel, 0.05% | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days
- interventionNames
- Drug: PEP005 (ingenol mebutate) Gel, 0.05%
- Device: Aluminium disk
- type
- EXPERIMENTAL
- label
- Group 2
- description
- PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days
- interventionNames
- Drug: PEP005 (ingenol mebutate) Gel, 0.05%
- Device: OpSite(TM) disk
- type
- EXPERIMENTAL
- label
- Group 3
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 * primary diagnosed and histologically confirmed sBCC located on the trunk or extremities which is suitable for excision Exclusion Criteria: * location of the sBCC lesion within 10cm of an incompletely healed wound, on the hand or foot, on the breast of women, on the anogenital area. * Undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the screening visit. * Use of acid-containing therapeutic products within 2 cm of the selected treatment area in the 2 weeks prior to the screening visit * Use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are acceptable), artificial tanners or topical steroids: within 2 cm of the selected treatment area. * Have received treatment with immunomodulators, or interferon/interferon inducers, systematic medications that suppress the immune system or UVB in the last 4 weeks * Have undergone treatment with 5-FU, imiquimod, diclofenac or photodynamic therapy within 2 cm of the selected treatment area within 8 weeks prior to any screening visit. * Use of systemic retinoids. * 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