Protocol summary

Study aim
Access to efficient treatment, low side effects and rapid responses in improvement of macular amyloidosis disease
Design
The aim of this study was to achieve high efficacy, low side effects and rapid response to improvement of macular amyloidosis.Thirty patients were studied and the areas of dark-spotted skin were divided into three separate regions in each patient, two areas treated with two different types of lasers, and one area as a control group did not receive any treatment.
Settings and conduct
Before laser therapy, photography and skin analysis are performed with a calorimeter and mexameter device. and dark skin lesions of each patient divided into 3 region. A: Dark skin patches will be operated under treatment by laser Q-switch 1064 ND:YAGR alone. B: Dark skin patches will be operated under treatment by pilling microlaser through Fractional Erbium short pulse and Q-Switch 1,064 nm Nd:YAG Laser at the same time. C: Dark skin patches will be defined as a control group with any treatment.Every patient will be under laser treatment for 3 session with 4 weeks interval at the skin and stem cell research center. Result evaluation and comparison will be done by calorimeter and mexameter.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Age more than 16 and less than 60; Skin phenotype between 3-5; Lack of inheritance and hormonal or malignant skin diseases. Exclusion criteria include: Using any drug related to decreasing pigment during last 2 weeks; No Solarium during last month, No pregnancy and breastfeeding.
Intervention groups
First intervention group: Region of laser Q-switch Nd:YAG, 1064 (part A) Second intervention group: Laser region by Q-switch Nd:YAG, 1064 and Fractional Erbium (part B) And the third group: that does not receive any treatment as the control zone.(part G)
Main outcome variables
Melanin Index; side effects; patient's satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080901001159N23
Registration date: 2019-05-25, 1398/03/04
Registration timing: retrospective

Last update: 2019-05-25, 1398/03/04
Update count: 0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
2015-03-21, 1394/01/01
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
2018-08-23, 1397/06/01
Scientific title
Comparison of the efficacy of laser Q-switch 1064 ND:YAGR and erbium laser on the Hyperpigmentation of Macular Amyloidosis
Public title
Treatment of Hyperpigmentation skin on Macular Amyloidosis patient with using two different types of lasers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 16 and less than 60 Skin phenotype between 3-5 lack of acute infection in part of body which is under laser treatment Lack of inheritance and hormonal or malignant skin diseases
Exclusion criteria:
Using any drug related to decreasing pigment during last 2 weeks Laser therapy in order to treat macular during last 1 month No Solarium during last month No pregnancy and breastfeeding.
Age
From 16 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Not randomized
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2014-02-17, 1392/11/28
Ethics committee reference number
92-02-150-22574-101834

Health conditions studied

1

Description of health condition studied
Macular amyloid
ICD-10 code
L99.0
ICD-10 code description
Amyloidosis of skin

Primary outcomes

1

Description
Melanin Index
Timepoint
Before and after laser therapy
Method of measurement
Multi Probe adaptor

Secondary outcomes

empty

Intervention groups

1

Description
Region of laser Q-switch Nd:YAG, 1064 nanometer: On the one side of the macular or (partA) , three sessions with four weeks intervals will be treated with with laser Q-switch Nd:YAG, 1064 nanometer with flounce equal to 700-1200 Joules per centimeter
Category
Treatment - Devices

2

Description
Laser region by Q-switch and microlaser pilling: In the second intervention group, another part of disaster region (part B), simultaneously for three sessions at intervals of four weeks, will be operated under treatment with laser Q-switch Nd: YAG and microlaser pilling
Category
Treatment - Devices

3

Description
Control Group: G region defined in disorder, as the control group does not receive any treatment
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sara Zolghadr
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
nilforoosh@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
nilforoosh@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and Stem cell Research Center of Tehran 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
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sara Zolghadr Elizei
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
Email
saraz85182@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
Email
nilforoosh@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mona Mahmoudbeyk
Position
Research manager
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
Email
mmahoodbeyk@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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