The objective of this nonrandomized, clinical trial study is to investigate the outcome of combination of curettage and CO2 laser therapy on basal cell carcinoma. In this study, 74 patients with 113 BCC lesions who pathologically documented basal cell carcinoma and met the inclusion criteria were recruited and subjected to treatment by CO2 laser. First, the apparent border of tumor was determined and later 3-5 mm of marginal skin of tumor was demarcated. In the later step, the tumoral lesion was debalcated by curettage. Finally, the induced defect and marginal skin were subjected to treatment with 2-3 passes of pulse mode co2 laser system with16-20watts power and 500-700 micro-second. For evaluation of treatment, photography was done before and after the treatment on the patients. The patients were followed-up for assessment of improvement and complications such as, repair of ulcer, scar formation and retraction at regular interval time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105076403N1
Registration date:2011-08-29, 1390/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-29, 1390/06/07
Registrant information
Name
Hossein Kavoussi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1837 5424
Email address
hkawosi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah university of Medical sciences
Expected recruitment start date
2006-07-01, 1385/04/10
Expected recruitment end date
2010-12-17, 1389/09/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of basal cell carcinoma with curettage co2 laser
Public title
Efficacy of curettage and co2 laser in treatment of basal cell carcinoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pathologically documented basal cell carcinoma
Exclusion criteria: basal cell carcinoma with deep ulcer, recurrent basal cell carcinoma, metastasis, association with bleeding diathesis, underlying repair disorder
Age
From 20 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
113
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Shahid Beheshty Blvd
City
Kermanshah
Postal code
Approval date
2011-05-09, 1390/02/19
Ethics committee reference number
7/420/6330/پ
Health conditions studied
1
Description of health condition studied
basal cell carcinoma
ICD-10 code
C00-C75
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
Treatment
Timepoint
At the end of the first, second, fourth week and every 3 month thereafter.
Method of measurement
Clinical observation
Secondary outcomes
1
Description
Scar
Timepoint
At the end of the first, second, fourth week and every 3 month thereafter.
Method of measurement
clinical observation
Intervention groups
1
Description
Use of combination of curettage and 2-3 pass of co2 laser with 16-20 watt and 500-700 microsecond
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajdaie clinic
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Shahid Beheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Hossein Kavoussi
Position
Assistant professsor
Other areas of specialty/work
Street address
Hajdaie clinic, Golestan Blvd
City
Kermanshah
Postal code
Phone
+98 83 1837 5424
Fax
Email
hkawosi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hossein Kavoussi
Position
Dermatologist
Other areas of specialty/work
Street address
Hajdaie clinic, Golestan Blvd
City
Kermanshah
Postal code
Phone
+98 83 1837 5424
Fax
+98 83 1427 4623
Email
hkawosi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)