Advanced Search

Study Preview



Study Title and Description

Comparison of aminolevulinic acid (ALA)-thermogel-PDT with methyl-ALA-thermogel-PDT in basal cell carcinoma.



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

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Comparison of aminolevulinic acid (ALA)-thermogel-PDT with methyl-ALA-thermogel-PDT in basal cell carcinoma.
Author Schleier P., Berndt A., Kolossa S., Zenk W., Hyckel P., Schultze-Mosgau S.
Country Department of Maxillofacial Surgery/Plastic Surgery, Friedrich Schiller University Jena, Germany.
Year 2007
Numbers Pubmed ID: 25047438

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 ALA-thermogel PDT
  • Comments Comments (
    0
    ) |
2 mALA-thermogel PDT
  • 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. Single center
  • Comments Comments (
    0
    ) |
Country/Region Germany (Friedrich-Schiller University Jena)
  • Comments Comments (
    0
    ) |
Funding No industry support
  • Comments Comments (
    0
    ) |
Inclusion criteria (1) histologically verified BCC of the skin, (2) histologically proven superficial BCC with no deep infiltration (<2 mm), (3) no morpheic and pigmented BCC, and (4) good patient compliance.
  • Comments Comments (
    0
    ) |
Exclusion criteria (1) unclear histology, (2) clinically nodular BCC, (3) expected poor compliance of the patient, (4) untreated diabetes mellitus, and (5) pregnancy
  • Comments Comments (
    0
    ) |
N Enrolled/Randomized/Analyzed 24
  • Comments Comments (
    0
    ) |
24
  • Comments Comments (
    0
    ) |
24
  • Comments Comments (
    0
    ) |
Notes/Comments 112 BCC on 24 patients.
  • 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)
  • Comments Comments (
    0
    ) |
Secondary size assessment
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question ALA-thermogel PDT mALA-thermogel PDT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 69.9 71.8 74
  • Comments Comments (
    0
    ) |
42-96 49-88 42-96
  • Comments Comments (
    0
    ) |
7 mm
  • Comments Comments (
    0
    ) |
3-12 mm
  • Comments Comments (
    0
    ) |
Gender/Racial descent 6 4
  • Comments Comments (
    0
    ) |
46.15 36.36
  • Comments Comments (
    0
    ) |
Lesion location 0 0
  • Comments Comments (
    0
    ) |
0 0
  • Comments Comments (
    0
    ) |
39 21
  • Comments Comments (
    0
    ) |
54.17 52.5
  • Comments Comments (
    0
    ) |
face= face+ frontal+temporal+infraorbital+supraorbital+nose+cheek+chin face= face+ frontal+temporal+infraorbital+supraorbital+nose+cheek+chin
  • Comments Comments (
    0
    ) |
15 12
  • Comments Comments (
    0
    ) |
20.83 30
  • Comments Comments (
    0
    ) |
scalp= occipital+calotte scalp= occipital+calotte
  • Comments Comments (
    0
    ) |
2 0
  • Comments Comments (
    0
    ) |
2.78 0
  • Comments Comments (
    0
    ) |
1 0
  • Comments Comments (
    0
    ) |
1.39 0
  • Comments Comments (
    0
    ) |
0 0
  • Comments Comments (
    0
    ) |
0 0
  • Comments Comments (
    0
    ) |
7 2
  • Comments Comments (
    0
    ) |
9.72 5
  • Comments Comments (
    0
    ) |
extremities=upper arm+forearm+lower leg extremities=upper arm+forearm+lower leg
  • Comments Comments (
    0
    ) |
8 5
  • Comments Comments (
    0
    ) |
11.11 12.5
  • Comments Comments (
    0
    ) |
trunk/neck=upper body+neck+back+shoulder trunk/neck=upper body+neck+back+shoulder
  • Comments Comments (
    0
    ) |
0 0
  • Comments Comments (
    0
    ) |
0 0
  • Comments Comments (
    0
    ) |
  • 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 13 11
  • Comments Comments (
    0
    ) |
72 40
  • Comments Comments (
    0
    ) |
13 11
  • Comments Comments (
    0
    ) |
72 40
  • Comments Comments (
    0
    ) |
0 0
  • Comments Comments (
    0
    ) |
0 0
  • Comments Comments (
    0
    ) |
13 11
  • Comments Comments (
    0
    ) |
72 40
  • Comments Comments (
    0
    ) |
Lesion extent number of people 112
  • Comments Comments (
    0
    ) |
lesions
  • Comments Comments (
    0
    ) |
0
  • Comments Comments (
    0
    ) |
112
  • Comments Comments (
    0
    ) |
0
  • Comments Comments (
    0
    ) |
0
  • Comments Comments (
    0
    ) |
0
  • Comments Comments (
    0
    ) |
Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure ALA-thermogel PDT mALA-thermogel PDT


12 weeks

N Analyzed 72 lesions 40 lesions
Counts 28 17
Percentage 38.9 42.5
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure ALA-thermogel PDT mALA-thermogel PDT


6 months

N Analyzed 72 lesions 40 lesions
Counts 8 5
Percentage 11.1 12.5
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure ALA-thermogel PDT mALA-thermogel PDT


n/a N/A

N Analyzed 13 subjects 11 subjects
Counts 8 5
Percentage 61.5 45.45
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure ALA-thermogel PDT mALA-thermogel PDT


n/a N/A

N Analyzed 13 patients 11 patients
Counts 5 2
Percentage 38.46 18.18
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure ALA-thermogel PDT mALA-thermogel PDT


n/a seconds

N Analyzed 13 subjects 11 subjects
Counts 0 2
Percentage 0 18.18


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes
  • Comments Comments (
    0
    ) |
RCT:....Adequate allocation concealment reported No
  • Comments Comments (
    0
    ) |
RCT:....Adequate blinding of PATIENTS reported Yes
  • Comments Comments (
    0
    ) |
RCT:....Adequate blinding of PROVIDERS reported Yes
  • Comments Comments (
    0
    ) |
ALL....Adequate blinding of OUTCOME ASSESSORS reported Yes
  • 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).
  • Comments Comments (
    0
    ) |
RCT.....Is the treatment effect by Intention to treat? Unsure
  • 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 Yes pain specifics unavailable
  • Comments Comments (
    0
    ) |
Overall, by outcome (judgement - put directly into notes field) moderate for all outcomes
  • Comments Comments (
    0
    ) |
ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome?
  • Comments Comments (
    0
    ) |

Quality Rating
Guideline Used Overall Rating