Comparison between microneedling plus topical tranexamic acid and microneedling in patients with macular amyloidosis referred to dermatology clinic of Shohada-e-Tajrish Hospital and Loghman-Hakim Hospital
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 3 on 22 patients. Excel software (randbetween function) was used for randomization.
Settings and conduct
This survey will be conducted in Shohadaye Tajrish Hospital and Loghman Hakim Hospital. 22 macular amyloidosis patients will randomly divided to microneedling and tranexamic acid plus microneedling group.
Participants/Inclusion and exclusion criteria
1.Age 18-60
2.Confirming the diagnosis of macular amyloidosis by a dermatologist
3.bilateral macular amyloidosis on trunk and extremities
4.Patients with skin type 2_4 Fitzpatrick
5.Filling out the informed consent form
Intervention groups
Tranexamic acid and microneedling group: 4 sessions of microneedling with topical tranexamic acid every two weeks
microneedling group: 4 sessions of microneedling every two weeks
Main outcome variables
skin pigmentation and its pattern
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220101053588N1
Registration date:2022-01-24, 1400/11/04
Registration timing:registered_while_recruiting
Last update:2022-01-24, 1400/11/04
Update count:0
Registration date
2022-01-24, 1400/11/04
Registrant information
Name
Shima Moslemi Haghighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 25719
Email address
mhaghighishima@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-12, 1400/10/22
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between microneedling plus topical tranexamic acid and microneedling in patients with macular amyloidosis
Public title
Comparison between microneedling plus topical tranexamic acid and microneedling in patients with macular amyloidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60
Confirming the diagnosis of macular amyloidosis by a dermatologist
bilateral macular amyloidosis on trunk and extremities
Patients with skin type 2_4 Fitzpatrick
Filling out the informed consent form
Exclusion criteria:
Pregnancy and lactation
Past history of keloid formation
Presence of active acne on site of macular amyloidosis
Other skin disorders
Hypersensitivity to lidocaine
Application of other topical medications in the past month
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
One of the randomization methods is using the RANDBETWEEN function in Excel. This function allows us to generate random numbers. To generate a random number in this study with a sample size of 22, between the two numbers 1 and 0, the function = (0,1) Randbetween is used. This function creates a column of random numbers from 0 to 1. The rand () function sets the numbers with equal probability in this selection interval. The chance of selecting any number in this interval is equal to the other numbers. This means that the treatment on the left or right side of the back or arms of each person is assigned to enter one of two treatments (doing treatment / not doing treatment). These data are 22 people that are randomly assigned to the numbers 0 and 1. In total, people with the number 1 receive treatment on the right side and people with the number 0 receive treatment on the left side of their body.
No Right=1,left=0
1 1
2 0
3 1
4 0
5 0
6 1
7 0
8 0
9 1
10 0
11 1
12 1
13 0
14 0
15 1
16 1
17 1
18 0
19 0
20 1
21 1
22 0
Blinding (investigator's opinion)
Single blinded
Blinding description
The method of one-sided blinding in this study will be that the statistical analyst is unaware of the eطposure recثهved by patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Skin Research Center- Shahid Beheshti University of Medical Sciences
Street address
The SBMU SRC (Skin Research Center), Shohada-E- Tajrish Educational Hospital, Qods Sq. , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19899 34148
Approval date
2021-08-07, 1400/05/16
Ethics committee reference number
IR.SBMU.SRC.REC.1400.001
Health conditions studied
1
Description of health condition studied
Macular Amyloidosis
ICD-10 code
e85.8
ICD-10 code description
Other amyloidosis
Primary outcomes
1
Description
clinical improvement of pigmentation
Timepoint
first session and two weeks after final session
Method of measurement
comparison of photos by 2 dermatologist and fotofinder device
2
Description
pigmentation pattern
Timepoint
first session and two weeks after final session
Method of measurement
checking for rippling
3
Description
patient satisfaction
Timepoint
two weeks after final session
Method of measurement
asking the patient
Secondary outcomes
1
Description
side effects
Timepoint
Since 2weeks after starting of the treatment, till 2 weeks after the last session
Method of measurement
Asking the patient, examination by dermatologist
Intervention groups
1
Description
Intervention group: First, all patients who have the criteria to enter the Survey, informed i consent to participate in the study is obtaibed. Prior to treatment, any contamination is removed from the skin with saline solution, and an anesthetic gel (lidocaine 2.5% and prilocaine 2.5%) is used and left on the skin for 30 minutes. The anesthetic gel is then removed from the skin and the site is disinfected with alcohol. One half of the lesion was randomly (using a random number table) treated with microneedling (With 36 needles cartridge and a depth of 0.5 to 1 mm until blood dew was observed) and 5 cc of tranexamic acid solution (500mg / 5cc). The other half is treated with microneedling (With 36 needles cartridge and with a depth of 0.5 to 1 mm until blood clot is observed) and the patient stops using mometasone for 24 hours after each treatment session and The patient avoids washing the areas and after 24 hours,. Patients apply a thin layer of mometasone to the lesions once daily. It is recommended not to use other topical medications during treatment. Four sessions of treatment at two-week intervals are performed on each patient. Patients are examined and photographed with Fotofinder in the first session (baseline time) and two weeks after the end of treatment. Side effects are measured in the second session of treatment and patients are advised in case of any complications at any time to refer to make decisions or the interventions.
Category
Treatment - Drugs
2
Description
Control group: Other side of the patient's body which is not treated with tranexamic acid. Other interventions are the same as case group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Mehdi Gheisari
Street address
Shohadaye Tajrish Hospital. 1989934148.Shahrdari St, Tehran Province, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
mgheisari@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Mehdi Gheisari
Street address
Loghman Hakim Hospital. Kamali ave. South Kargar St. Tehran
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
mgheisari@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Skin Research Center Of Shahid Beheshti Universiy Of Medical Sciences
Full name of responsible person
Hamideh Moravvej Farshi
Street address
Shohadaye Tajrish Hospital. 1989934148.Shahrdari St, Tehran Province, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Hamidehmoravej@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin Research Center Of Shahid Beheshti Universiy 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdi Gheisari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shohadaye Tajrish Hospital. 1989934148.Shahrdari St, Tehran Province, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
mgheisari@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdi Gheisari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shohadaye Tajrish Hospital. 1989934148.Shahrdari St, Tehran Province, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
mgheisari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shima Moslemi haghighi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shohadaye Tajrish Hospital. 1989934148.Shahrdari St, Tehran Province, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
mhaghighishima@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All information except the patient name
When the data will become available and for how long
One year after publishing the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
All information except the patient name is available.
From where data/document is obtainable
The researcher of this study, Dr Mehdi Gheisari
What processes are involved for a request to access data/document
sending Email to the researcher: mgheisari@sbmu.ac.ir