Skip to main content
. 2013 Jun 24;2013(6):CD007281. doi: 10.1002/14651858.CD007281.pub2

Perrett 2007.

Methods D: This was an open‐label, single‐centre (dedicated dermatology clinic for organ transplant recipients), randomised intrapatient comparative study
RS: Participants randomly assigned T1 to 1 lesional area or T2 to a parallel lesional area (Pocock 1983)
AC: The study did not state a method of allocation concealment (intrapatient study)
B: There was no evidence of blinding
Participants UK: 8 post‐transplant participants (6 men, 2 women) with history of epidermal dysplasia (8 actinic keratoses, 10 lesions of Bowen's disease)
The lesional size treated ranged from 39 mm² to 5010 mm², although specific sizes were not provided
Inclusion criteria of the trial
  • Participants with 2 clinically and histologically equivalent areas of epidermal dysplasia, approximately the same size, on anatomically separate sites

  • Histological confirmation of diagnosis

  • No lesion was treated in the 8 weeks preceding the study

  • For multiple lesions, a single diagnostic biopsy was performed and clinically similar lesions were treated as for the histological diagnosis of the index lesion

Interventions
  • T1: 5‐FU cream, massaged into lesional areas twice daily for 3 weeks

  • T2: MAL‐PDT (dose = 75 J cm‐²) twice at a 1‐week interval (cream was applied 1 mm thick to area and covered with a semipermeable adhesive dressing; 3 hours later cream was washed off with normal saline before illumination with non‐coherent red light)


Prior to treatment, all lesions were gently abraded with curette to remove excess thick surface scale
Outcomes
  1. Complete resolution rate (primary outcome: complete response corresponded to complete resolution of the treated lesion and partial response corresponded to at least 30% reduction in lesional area)

  2. Overall reduction in lesional area, treatment‐associated pain, and erythema

  3. Cosmetic outcome (assessed by participant and clinician) and global patient preference assessment. Participants were reviewed 1, 3, and 6 months after treatment

Notes Intervention product information/details
  • 5‐FU cream (Efudix®; Valeant Pharmaceuticals International, Basingstoke, UK)

  • MAL cream (Metvix®; PhotoCure ASA, Oslo, Norway/Galderma SA, Paris France) 160 mg g‐¹

  • non‐coherent red light source (633 +/‐ 15 nm; Paterson PDT, Omnilux, Photo Therapeutics Ltd) with an irradiance of 80 mWcm‐², and a total dose of 75 J cm‐²

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The only detail the paper gave was a textbook reference: Pocock 1983
Allocation concealment (selection bias) Unclear risk The paper gave no detail
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All 8 participants completed treatment and 6‐months of follow‐up. 1 participant assessed at 6 months died shortly afterwards of unrelated causes
Blinding participants Unclear risk There was no evidence of blinding
Blinding clinicians Unclear risk There was no evidence of blinding
Blinding pathologist Unclear risk There was no evidence of blinding
Blinding outcome assessor Unclear risk The study did not blind assessments
Baseline comparability Low risk This was an intrapatient comparative study; therefore, there was low risk of bias as lesions treated were in the same participant and chosen to be comparable