Determining and comparing the effectiveness of Q-switched laser Nd: YAG 1064nm and Er: YAG 2940nm in the treatment of macular amyloidosis.
Design
The study is a randomized clinical trial of a "non-inferiority" that will be performed on 39 patients referred to dermatological clinic with a clinical diagnosis of macular amyloidosis. Excel software Rand function will be used for randomization.
Settings and conduct
This study will be performed on patients with clinical signs of macular amyloidosis referred to the dermatology clinic of Al-Zahra Hospital. In each patient, the lesion will be randomly divided into 2 areas A and B , that area A will be treated with 4 sessions of Nd: YAG 1064nm Q-switched laser with intervals of 4 weeks, and area B will be subjected to 4 sessions of treatment with 4 weeks intervals of Er: YAG2940 laser and immediate use of clobetasol ointment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Clinical signs of amyloidosis; Age range 18-60 years; Existence of at least 1 lesion with an area of 5 to 10 cm2; More than 6 months have passed since the lesion occurred.
Exclusion criteria: Pregnancy, Lactation; Decision to become pregnant in the next 5 months; History of hypertrophic scarring; Keloid; Melanoma; Other skin cancers, Treatment with systemic retinoids in the last 6 months; Any systemic treatment (for this disease) during last 3 months; Any topical treatment in the last month.
Intervention groups
In all patients, the lesion will divided into 2 areas, A and B, where area A will be treated with the Q-switch 1064 laser and area B will be treated with Erbium YAG laser. Also, all patients will be treated topically with a combination of Kligman formulation, including: tretinoin, hydroquinone and clobetasol, on a daily basis at home.
Main outcome variables
1-Change in the intensity of pigmentation
2-Changing in the intensity of itching
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200811048363N1
Registration date:2021-03-04, 1399/12/14
Registration timing:prospective
Last update:2021-03-04, 1399/12/14
Update count:0
Registration date
2021-03-04, 1399/12/14
Registrant information
Name
Maral Yazdanpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3667 1163
Email address
marlyyazdan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of 1064nm Q-switched ND:YAG laser and Er:YAG2940nm laser in treatment of macular amyloidosis
Public title
Comparative study of 1064nm Q-switched ND:YAG laser and Er:YAG2940nm laser in treatment of macular amyloidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with macular amyloidosis clinical symptoms
Patients with at least 5 to 10 cm2 macular amyloidosis skin lesion on the trunk or limbs
At least 6 months have passed since the onset of skin lesion
Exclusion criteria:
Pregnancy, breastfeeding or deciding to get pregnant in the next 2 months
Personal history of hypertrophic scar or keloid formation
Personal history of melanoma or other skin cancers
History of systemic retinoid therapy during last 6 months
History of any systemic treatment during the last 3 months for macular amyloidosis
history of any topical treatment during the last month for macular amyloidosis
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the fact that in our study both types of interventions will performed on one person (split lesion method), randomization only applies to the side of the patient's lesion. Our method for randomization is based on even and odd calendar days, so patients referred on the even days , right side of the lesions will considred area- A (Q-switched laser 1064nm) and the left side of the lesion will considered as area- B (Erbium laser 2940). For the patients referred on the odd dates allocation of the intervention area will be the opposite.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the fact that the type of laser intervention is high-power lasers, in order to protect the patient, he/she should use lead protective eyewear,
during the process, so she/he will be unaware of the laser type; results will be compared by befor and after (intervention) photographs, by a neutral specialist who is unaware of the type and location of various treatments.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Commitee for Ethnics in Biomedical Research
Before the intervention (0) ; 4 weeks after the last session of intervention
Method of measurement
photography with a single camera
2
Description
Intensity changes of pigmentation
Timepoint
Before the intervention (0) ; 4 weeks after the last session of intervention
Method of measurement
Questionnaire with Visual Analogue Scale
3
Description
Intensity changes of itching
Timepoint
Before the intervention (0) ; 4 weeks after the last session of intervention
Method of measurement
Questionnaire with Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In each patient, the lesion will be randomly divided into 2 zones A and B (two squares of equal size). Zone A under 4 treatment sessions with 4-week intervals of Nd: YAG 1064nm Q-switched laser (device: HeliosIII) with fluence parameters 14 J/cm2 , spot size 3mm, energy 1000j . Also for all patients, Kligman combination (including: 0.05% tretinoin, 5% hydroquinone and 0.05% clobetasol in ethanol-based ) will be prescribed for daily use on the lesions at home.
Category
Treatment - Other
2
Description
Intervention group: In each patient, the lesion will be randomly divided into 2 zones A and B (two squares of equal size) and zone B will under 4 treatment sessions with 4 weeks intervals of laser Er: YAG2940 (Lotus II device, Laseroptek) with parameters: spot size 10mm / energy: 1500j and fe: 3Hz and immediately take clobetasol ointment. Also for all patients, Kligman combination (including: 0.05% tretinoin, 5% hydroquinone and 0.05% clobetasol in ethanol-based ) will be prescribed for daily use on the lesions at home.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Al-zahra Hospital
Full name of responsible person
Maral Yazdanpanah
Street address
No.32, Baghe-Negar Ave., Chahar-Bagh-Bala St.,
City
Isfahan
Province
Isfehan
Postal code
8163675791
Phone
+98 31 3667 1163
Email
marlyyazdan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooi Javanmard
Street address
Vice Chancellor for Research and Technology, Building No. 4 , Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maral Yazdanpanah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.32, Baghe-Negar Ave., Chahar-Bagh-Bala St
City
Isfahan
Province
Isfehan
Postal code
8163675791
Phone
+98 31 3667 1163
Email
marlyyazdan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maral Yazdanpanah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.32, Baghe-Negar Ave.,Chahar-bagh_Bala St
City
Isfahan
Province
Isfehan
Postal code
8163675791
Phone
0098313671163
Email
marlyyazdan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maral Yazdanpanah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.32, Baghe-Negar Ave., Chahar-Bagh-Bala St
City
Isfahan
Province
Isfehan
Postal code
8163675791
Phone
+98 31 3667 1163
Email
marlyyazdan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available