This study aims to evaluate the effect of Fractional Erbium glass 1540 Laser on treatment of macular amyloidosis.
Design
This clinical trial is conducted among female patients with macular amyloidosis in upper back areas. Patients, after being diagnosed with macular amyloidosis by a dermatologist, will be notified about the advantages and disadvantages of this trial and in case of agreement they will be asked to fill out written consent forms to be included in the study. Then, patients’ lesions are divided to 2 areas by random. One side is then treated with Fractional Erbium glass 1540 Laser (area A) and the other side, as control group, receives no treatment (area B).
Settings and conduct
No blinding will be done in the study and patients are those referring to Dermatology Clinic of Imam Reza Hospital.The following indices will be separately evaluated. 1-Clinical assessment: during each visit and also 4 and 12 weeks after last visit, digital images are taken from both areas by a Canon camera and are analyzed by computers. Primary evaluation is done by 2 blinded researchers based on factors such as rate and pattern (with or without rippling) of pigmentation, intensity of lesions and itching. The aforementioned factors are then measured 3 months after last visit as final evaluation. 2-Subjective assessment or patient global assessment: patients, same as specialists, are asked to grade their satisfaction during follow ups by numbers 0 to 5 with 0 meaning no improvement and 5 meaning complete satisfaction. 3-Safety assessment: includes recording erythema and edema rate by specialist and rate of pain after each visit based on VAS (visual analogue scale).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Clinically confirmed macular amyloidosis; macular amyloidosis lesions should be on upper back area; no current skin diseases like active dermatitis, active acne, hypertrophic scars or keloids.
Exclusion criteria: intolerance against laser treatment; pregnancy during treatment; other dermatologic diseases like skin infections and active lesions in the treatment area.
Intervention groups
Patients’ lesions are divided to 2 areas by random. One side is then treated with Fractional Erbium glass 1540 Laser (area A) and the other side, as control group, receives no treatment (area B).
Main outcome variables
based on rate and pattern of pigmentation, intensity of lesions and itching.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140414017271N4
Registration date:2018-02-04, 1396/11/15
Registration timing:registered_while_recruiting
Last update:2018-02-04, 1396/11/15
Update count:0
Registration date
2018-02-04, 1396/11/15
Registrant information
Name
Yalda Nahidi
Name of organization / entity
department of dermatology, Ebne Sina St, Emam Reza hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2490
Email address
nahidiy@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-07-25, 1395/05/04
Expected recruitment end date
2018-02-08, 1396/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Fractional Erbium glass 1540 Laser on treatment of macular amyloidosis
Public title
Evaluation the effect of Laser on treatment of macular amyloidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinically confirmed macular amyloidosis
macular amyloidosis lesions should be on upper back area
o current skin diseases like active dermatitis, active acne, hypertrophic scars or keloids
patients with Fitzpatrick skin types 2 to 4
written informed consent from patients for participation in the study and digital imaging from lesions
no use of Isotretinoin during the last 3 month
having no heart pacemaker
no record of sensitivity to lidocaine
Exclusion criteria:
unreal expectations from treatment results
macular amyloidosis lesions not being on upper back areas
intolerance against laser treatment
pregnancy during treatment
unwillingness of patient to continue participating in the study or digital imaging from lesions
Coagulopathy
Patients who were under topical treatment one month before study
existence of hypertrophic scars or keloids
Treatment with systemic retinoid during the last 6 month
other dermatologic diseases like skin infections and active lesions in the treatment area
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Then, patients’ lesions are divided to 2 areas by random. One side is then treated with Fractional Erbium glass 1540 Laser (area A) and the other side, as control group, receives no treatment (area B).
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
IR.MUMS.fm.REC.1395.36
Health conditions studied
1
Description of health condition studied
macular amyloidosis
ICD-10 code
L99.0
ICD-10 code description
Amyloidosis of skin
Primary outcomes
1
Description
Lesion pigmentation
Timepoint
During therapy, after each laser session and three month after last session
Method of measurement
Based on a grading system (1:low, 2:medium, 3:noticeable)
2
Description
Rate of rippling
Timepoint
During therapy, after each laser session and three month after last session
Method of measurement
Based on a grading system (0:without rippling, 1:with rippling)
3
Description
Intensity of lesion
Timepoint
During therapy, after each laser session and three month after last session
Method of measurement
Based on a grading system (0:without Lichenification, 1:with Lichenification)
4
Description
Itching
Timepoint
During therapy, after each laser session and three month after last session
Method of measurement
Based on a grading system (0:without itching, 1:with itching)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: one part of lesion receives Fractional non-ablative erbium laser for 3 sessions and its energy ranges from 8 to 15 Mj/MB2.
Category
Treatment - Other
2
Description
control group: one part of lesion receives no treatment.