Advanced Search

Study Preview



Study Title and Description

Imiquimod 5% cream in the treatment of superficial basal cell carcinoma: results of a multicenter 6-week dose-response trial.



Key Questions Addressed
1 Comparison of interventions
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Imiquimod 5% cream in the treatment of superficial basal cell carcinoma: results of a multicenter 6-week dose-response trial.
Author Marks R., Gebauer K., Shumack S., Amies M., Bryden J., Fox TL., Owens ML.
Country Department of Dermatology, St Vincent's Hospital Melbourne and the Skin & Cancer Foundation, Victoria, Australia.
Year 2001
Numbers Pubmed ID: 11312429

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Imiquimod BID Imiquimod 5% cream BID for 6 weeks
  • Comments Comments (
    0
    ) |
2 Imiquimod OD Imiquimod 5% cream OD for 6 weeks
  • Comments Comments (
    0
    ) |
3 Imiquimod BID 3/week Imiquimod 5% cream BID 3 days per week for 6 weeks
  • Comments Comments (
    0
    ) |
4 Imiquimod OD 3/week Imiquimod 5% cream OD 3 days per week for 6 weeks
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
  • Comments Comments (
    0
    ) |
Study design RCT
  • Comments Comments (
    0
    ) |
Multicenter etc. Multicenter
  • Comments Comments (
    0
    ) |
Country/Region Australia and New Zealand
  • Comments Comments (
    0
    ) |
Funding Industry funded
  • Comments Comments (
    0
    ) |
Inclusion criteria 18+ years old, biopsy-proven superficial BCC on head, neck, trunk or limbs, surface area 0.5-2 cm2, primary tumor, biopsy was <25% of the lesion
  • Comments Comments (
    0
    ) |
Exclusion criteria Infection, recurrent, on areas within 1 cm of the hairline, eyes, nose, mouth, ears, anogenital region, hands, and feet
  • Comments Comments (
    0
    ) |
N Enrolled/Randomized/Analyzed 99
  • Comments Comments (
    0
    ) |
99
  • Comments Comments (
    0
    ) |
99
  • Comments Comments (
    0
    ) |
Notes/Comments
  • Comments Comments (
    0
    ) |
Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
  • Comments Comments (
    0
    ) |
Preoperative assessment of clinical size of the tumor ... not reported ...
  • Comments Comments (
    0
    ) |
Percent non-primary (recurrent) 0
  • Comments Comments (
    0
    ) |
Secondary size assessment
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Imiquimod BID Imiquimod OD Imiquimod BID 3/week Imiquimod OD 3/week Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 0.7 0.9 1.0 61
  • Comments Comments (
    0
    ) |
cm2 cm2 cm2 23, 83
  • Comments Comments (
    0
    ) |
0.5, 2
  • Comments Comments (
    0
    ) |
cm2
  • Comments Comments (
    0
    ) |
Gender/Racial descent 27
  • Comments Comments (
    0
    ) |
27
  • Comments Comments (
    0
    ) |
99
  • Comments Comments (
    0
    ) |
100
  • Comments Comments (
    0
    ) |
Lesion location 32
  • Comments Comments (
    0
    ) |
32
  • Comments Comments (
    0
    ) |
"Upper extremities"
  • Comments Comments (
    0
    ) |
28
  • Comments Comments (
    0
    ) |
28
  • Comments Comments (
    0
    ) |
"Upper anterior/posterior trunk"
  • Comments Comments (
    0
    ) |
"Remainder occurring on the head and neck and lower limbs"
  • Comments Comments (
    0
    ) |
Skin type (Fitzpatrick score) 46
  • Comments Comments (
    0
    ) |
32
  • Comments Comments (
    0
    ) |
Number of lesions per patient 3 33 30 30
  • Comments Comments (
    0
    ) |
100 100 100 100
  • Comments Comments (
    0
    ) |
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 3 33 30 33
  • Comments Comments (
    0
    ) |
3 33 30 33
  • Comments Comments (
    0
    ) |
3 33 30 33
  • Comments Comments (
    0
    ) |
3 33 30 33
  • Comments Comments (
    0
    ) |
0 0 1 1
  • Comments Comments (
    0
    ) |
0 0 1 1
  • Comments Comments (
    0
    ) |
3 But 2 had treatment site itch and refused post-treatment excision Death from CVA ‡Target tumor occluded during the study because of excision of nearby nontarget tumors
  • Comments Comments (
    0
    ) |
3 33 30 33
  • Comments Comments (
    0
    ) |
33 30 33
  • Comments Comments (
    0
    ) |
Lesion extent number of people 99
  • Comments Comments (
    0
    ) |
1
  • Comments Comments (
    0
    ) |
1 patient had a nodular component
  • Comments Comments (
    0
    ) |
1
  • Comments Comments (
    0
    ) |
Not in our "high risk" grouping, but 1 had a "follicular component"
  • Comments Comments (
    0
    ) |
Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure Imiquimod BID Imiquimod OD Imiquimod BID 3/week Imiquimod OD 3/week


6 weeks

N Analyzed 3 33 30 33
Counts 0 4 8 10
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Imiquimod BID Imiquimod OD Imiquimod BID 3/week Imiquimod OD 3/week


N/A N/A

N Analyzed 3 33 30 33
Counts 3 8 4 1


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Not reported
  • Comments Comments (
    0
    ) |
RCT:....Adequate allocation concealment reported No Not reported
  • Comments Comments (
    0
    ) |
RCT:....Adequate blinding of PATIENTS reported No Open-label
  • Comments Comments (
    0
    ) |
RCT:....Adequate blinding of PROVIDERS reported Unsure Open-label
  • Comments Comments (
    0
    ) |
ALL....Adequate blinding of OUTCOME ASSESSORS reported Unsure Open-label
  • Comments Comments (
    0
    ) |
ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No
  • Comments Comments (
    0
    ) |
ALL.....Selective Reporting (judgement - put directly into notes field). Unclear - no protocol available but all outcomes of interest available
  • Comments Comments (
    0
    ) |
RCT.....Is the treatment effect by Intention to treat? No Not true ITT but number of dropouts is low
  • Comments Comments (
    0
    ) |
ALL....Group similarity at baseline. Unsure Minimal data given in table 1
  • Comments Comments (
    0
    ) |
ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Yes Stopped enrolling into BID arm because of concerns brought up from other studies
  • Comments Comments (
    0
    ) |
ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes
  • Comments Comments (
    0
    ) |
Overall, by outcome (judgement - put directly into notes field) Potential risk of bias given open-label. Also unable to assess differences in tumor location between groups. Overall moderate to high RoB
  • Comments Comments (
    0
    ) |
ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.