Advanced Search

Study Preview



Study Title and Description

Fractional carbon dioxide laser improves nodular basal cell carcinoma treatment with photodynamic therapy with methyl 5-aminolevulinate.



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

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Fractional carbon dioxide laser improves nodular basal cell carcinoma treatment with photodynamic therapy with methyl 5-aminolevulinate.
Author Lippert J., Smucler R., Vlk M.
Country Department of Photonic Medicine, 1st Medical Faculty, Charles University, Prague, Czech Republic.
Year 2013
Numbers Pubmed ID: 23725586

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Laser ablation + AFP + PDT
  • Comments Comments (
    0
    ) |
2 Laser ablation + PDT
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
  • Comments Comments (
    0
    ) |
Study design Prospective nRCS
  • Comments Comments (
    0
    ) |
Multicenter etc. Single center
  • Comments Comments (
    0
    ) |
Country/Region Czech Republic
  • Comments Comments (
    0
    ) |
Funding No industry support
  • Comments Comments (
    0
    ) |
Inclusion criteria one confirmed nBCC, and there was one tested nBCC per person, with a width of 20 to 30 mm
  • Comments Comments (
    0
    ) |
Exclusion criteria Patients with tumors in the middle portion of the face and areas adjacent to the eyes and ears
  • Comments Comments (
    0
    ) |
N Enrolled/Randomized/Analyzed 56
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
56
  • Comments Comments (
    0
    ) |
Notes/Comments split tumor design
  • Comments Comments (
    0
    ) |
Method of diagnosis ... Describe Biopsy/pathologic confirmation ... To verify the accuracy of the diagnosis, a biopsy sample, which was as small as possible so that the area intended for the experiment was not reduced, was taken from the peripheral portion of the tumor
  • Comments Comments (
    0
    ) |
Preoperative assessment of clinical size of the tumor ... other ... Tumor thickness was measured using high-resolution ultrasound
  • Comments Comments (
    0
    ) |
Percent non-primary (recurrent) NR
  • Comments Comments (
    0
    ) |
Secondary size assessment after the experiment was completed (18 months), further biopsies were performed for each patient. A 5-mm punch biopsy from each half of the tumor was taken to evaluate the tumor residuum.
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Laser ablation + AFP + PDT Laser ablation + PDT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 61.9
  • Comments Comments (
    0
    ) |
Gender/Racial descent 24
  • Comments Comments (
    0
    ) |
43
  • Comments Comments (
    0
    ) |
Lesion location 49 (87.5%) head (not H-zone or adjacent to the eyes or ears) cheeks, or neck 7 (12.5%) other parts of the body
  • Comments Comments (
    0
    ) |
Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient No data entered.
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 56
  • Comments Comments (
    0
    ) |
56
  • Comments Comments (
    0
    ) |
56
  • Comments Comments (
    0
    ) |
56
  • Comments Comments (
    0
    ) |
Lesion extent number of people 56 (100%)
  • 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 Laser ablation + AFP + PDT Laser ablation + PDT


18 months

N Analyzed 56 56
Counts 4 14


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported
  • Comments Comments (
    0
    ) |
RCT:....Adequate allocation concealment reported
  • Comments Comments (
    0
    ) |
RCT:....Adequate blinding of PATIENTS reported Yes
  • Comments Comments (
    0
    ) |
RCT:....Adequate blinding of PROVIDERS reported No
  • Comments Comments (
    0
    ) |
ALL....Adequate blinding of OUTCOME ASSESSORS reported No
  • 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). Unsure Cosmetic outcomes not reported by arm
  • Comments Comments (
    0
    ) |
RCT.....Is the treatment effect by Intention to treat?
  • Comments Comments (
    0
    ) |
ALL....Group similarity at baseline. Yes
  • Comments Comments (
    0
    ) |
ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field)
  • Comments Comments (
    0
    ) |
ALL (with AE results)....Were reported adverse events (of interest) precisely defined Unsure AEs not reported in depth
  • Comments Comments (
    0
    ) |
Overall, by outcome (judgement - put directly into notes field) moderate: outcome assessors not blinded; AEs and cosmetic outcomes given very short shrift
  • 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.