Comparative study of efficacy 4 lasers: PDL, QSwitch-Nd-YAG, CO2 and CO2+Qswitch-Nd-YAG in treatment of cutaneous macular amyloidosis
Design
IV-phase Randomized, parallel group trial with non-blinded outcome in case group
Settings and conduct
To comparative of efficacy 4 lasers on treatment of patients with cutaneous macular amyloidosis referred to Dermatology Clinic of Ahvaz Imam Khomeini Hospital, the ulcer divided to 4 sections and each one treated with one of PDL, QSwitch-Nd-YAG, CO2 and CO2+Qswitch-Nd-YAG lasers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with cutaneous macular amyloidosis referred to Dermatology Clinic of Ahvaz Imam Khomeini Hospital
Exclusion criteria: history of allergy due to laser therapy
Intervention groups
1st Intervention group: the first quarter of ulcer treated with PDL laser.
2th Intervention group: the second quarter of ulcer treated with QSwitch-Nd-YAG laser.
3th Intervention group: the Third quarter of ulcer treated with CO2 laser.
4th Intervention group: the last quarter of ulcer treated with CO2+Qswitch-Nd-YAG laser.
Main outcome variables
ulcer improvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181217042026N1
Registration date:2019-01-15, 1397/10/25
Registration timing:registered_while_recruiting
Last update:2019-01-15, 1397/10/25
Update count:0
Registration date
2019-01-15, 1397/10/25
Registrant information
Name
Forough Ghanatir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3587 4366
Email address
ghanatir.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of efficacy 4 lasers: PDL, QSwitch-Nd-YAG, CO2 and CO2+Qswitch-Nd-YAG in treatment of cutaneous macular amyloidosis
Public title
Comparative study of efficacy 4 lasers: PDL, QSwitch-Nd-YAG, CO2 and CO2+Qswitch-Nd-YAG in treatment of cutaneous macular amyloidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with cutaneous macular amyloidosis referred to Dermatology Clinic of Ahvaz Imam Khomeini Hospital
Exclusion criteria:
history of allergy due to laser therapy
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
4
one quarter of ulcer
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 Boulevard, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1234567899
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.AJUMS.REC.1397.376
Health conditions studied
1
Description of health condition studied
cutaneous macular amyloidosis
ICD-10 code
L99.0
ICD-10 code description
Amyloidosis of skin
Primary outcomes
1
Description
ulcer improvement
Timepoint
after laser therapy and 4 months after that
Method of measurement
observation of ulcer area
Secondary outcomes
empty
Intervention groups
1
Description
1st Intervention group: the first quarter of ulcer treated with PDL laser.
Category
Treatment - Other
2
Description
2th Intervention group: the second quarter of ulcer treated with QSwitch-Nd-YAG laser.
Category
Treatment - Other
3
Description
3th Intervention group: the Third quarter of ulcer treated with CO2 laser.
Category
Treatment - Other
4
Description
4th Intervention group: the last quarter of ulcer treated with CO2+Qswitch-Nd-YAG laser.