Critical appraisal:Siller G, Rosen R, Freeman M, Welburn P, Katsamas J, Ogbourne SM 2010
Risk of bias assessment: Randomised Controlled Trial (Cochrane risk of bias tool)
Random sequence generation
- An independent clinical research organisation used a computer-generated randomisation schedule with a block size of eight to assign eligible patients to treatment on days 1 and 2 (Arm A) or days 1 and 8 (Arm B) and within each group to treatment with ingenol mebutate gel, 0.0025%, 0.01% or 0.05% or matching vehicle gel. Patients were randomised and assigned to active treatment or vehicle in a ratio of 8:2.
- Study medication was labelled with a patient number before the trial commenced and patients were allocated sequentially at each centre according to the randomisation schedule.
Active and vehicle gels were physically indistinguishable and identical packaging was used to maintain concealment of both the investigator and patients regarding allocation to treatment.
- Active and vehicle gels had same packaging
Incomplete outcome data
- Arm A (n=30) Arm B (n=30)
2 patients (1x0.01% IM; 1x0.05% IM) in the Arm A group discontinued due to AE.
Selective outcome reporting
- Safety and efficacy of IM gel was reported on by authors
Other sources of bias
|Low risk of bias||Additional comments:|
- Siller G, Rosen R, Freeman M, Welburn P, Katsamas J, Ogbourne SM. PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial. Australas J Dermatol 2010 May;51(2):99-105 Available from: http://www.ncbi.nlm.nih.gov/pubmed/20546215.
- Assigned to
- Topic area
- Guidelines:Keratinocyte carcinoma/Private
- Clinical question
Section below only relevant for Cancer Council Project Officer