Clinical trial · Interventional
To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC
An Open-label, Multi-center, Dose-escalation, Cohort Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel Given as Either a Single Application (on Day 1) or as Two Applications (on Day 1 and Day 8) to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk.
NCT00432185CI-TRIAL-00020920completedPhase 2ClinicalTrials.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 study is to determine maximum tolerated dose level (MTD) of PEP005 Topical Gel for the treatment of superficial basal cell carcinoma on the trunk
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEP005 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- One day treatment
- interventionNames
- Drug: PEP005
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Two day treatment
- interventionNames
- Drug: PEP005
Primary outcomes (1)
- measure
- Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring.
- timeFrame
- 85 days
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
1. Male or female patients at least 18 years of age. 2. A primary clinically diagnosed and histologically confirmed sBCC lesion located on the trunk which is suitable for excision the histological diagnosis should be made no more than 60 days prior to the screening visit the biopsy specimen should have removed no more that 20% of the total tumour mass 3. Ability to follow study instructions and likely to complete all study requirements. 4. Written informed consent has been obtained. 5. Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package.
References
Publications (2)
- RESULTGross K. Safety and efficacy of ingenol mebutate (PEP005) gel for topical treatment of superficial basal cell carcinoma. J Am Acad Dermatol 2009; 60(3, Suppl. 1): AB141; P2928
- RESULTGross K, Schmieder GJ, Tu J. Maximum Tolerated Dose and Safety of PEP005 (ingenol mebutate) Gel for Topical Treatment of Superficial Basal Cell Carcinoma. Summer Academy, American Academy of Dermatology meeting, Boston, MA, 2009. 2009: Poster no. 1902 (31 p.)