The aim of this study is to evaluate the efficacy and safety of 585-nanometer Pulsed dye laser alone and with cryotherapy in treating superficial basal cell carcinoma. Study design will be random clinical trial, double-blinded, without control with placebo and single-center. Study population will be chosen out of those patients affected by superficial basal cell carcinoma who refer to the Dermatology Clinic of Imam Khomeini Hospital in Ahvaz and meet the inclusion criteria including pathologically ducumented basal cell carcinoma and maximum tumor diameter of 30 millimeters. The main exclusion criteria will include skins with Fitzpatrick type of more than 3, coagulation disorders or recent receiving of anticoagulant, and consumption of drugs sensitive to light. Sample size will be 32 tumor of superficial basal cell carcinoma. Patients will randomly be divided into two groups and the first group will be treated by 585-nanometer pulsed dye laser alone, and the second group will also be cryotherapied in addition to laser. There will be two treatment sessions with intervals of 3 weeks. Six months after the last treatment session, histologic and clinical assessment will be performed. Primary outcome of this study is tumor remission 6 months after the last treatment session. The second outcome is studying the safety (side effects) of applied therapeutic methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030732933N1
Registration date:2017-05-21, 1396/02/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-21, 1396/02/31
Registrant information
Name
Pedram Nazari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 7705
Email address
nazari.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between efficacy and safety of 585-nanometer pulsed dye laser alone and with cryotherapy in treating superficial basal cell carcinoma
Public title
The effect of laser alone and with cryotherapy in treating superficial basal cell carcinoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Pathologically documented basal cell carcinoma; maximum tumor diameter of 30 millimeters
Exclusion criteria: Skins with Fitzpatrick type of higher than 3; coagulation disorders or recent receiving of anti-coagulant agents; consumption of light-sensitive drugs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2016-12-03, 1395/09/13
Ethics committee reference number
IR.AJUMS.REC.1395.719
Health conditions studied
1
Description of health condition studied
superficial basal cell carcinoma
ICD-10 code
C43-C44
ICD-10 code description
Melanoma and other malignant neoplasms of skin
Primary outcomes
1
Description
tumor remission
Timepoint
6 months after the last treatment session
Method of measurement
Clinical observations and pathology
Secondary outcomes
1
Description
Scar
Timepoint
After each treatment session and 6 months after the last treatment session
Method of measurement
Clinical observation
Intervention groups
1
Description
585-nanometer PDL laser with power of 9 joules, in 450 microseconds, for 2 treatment sessions with 3-week intervals
Category
Treatment - Devices
2
Description
585-nanometer PDL laser with power of 9 joules, in 450 microseconds, followed by cryotherapy with one unit of liquid nitrogen (CRY-ACW) using spray method during two freeze cycles each of which being 4±2 minutes, for 2 sessions with intervals of 3 weeks