Efficacy of platelet-rich plasma injection in combination with tranexamic acid compared with tranexamic acid injection alone inthe treatment of macular amyloidosis
Comparison of the efficacy of platelet-rich plasma injection in combination with tranexamic acid and tranexamic acid injection alone in the treatment of macular amyloidosis.
Design
Clinical trial with control group, double-blind, randomized, on 10 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Interventions will be performed in the skin and stem cells center.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age with a clinical diagnosis of macular amyloidosis who have informed consent to enter the study and have the possibility to attend visits and follow-up sessions.
Intervention groups
At the beginning of the study, the affected area in each patient is divided into two parts and the areas are named as A and B. In both mentioned areas, tranexamic acid ampoules are injected intradermally. Next, two envelopes are presented to each of the patients, which contain the letters A and B, and the patient is not aware of the contents of the envelope. By choosing the envelope containing the letter A, platelet-rich plasma is injected at a distance of 1 cm from each other in area A. . In area B, normal saline injection is performed as a control group. Also, if you choose the envelope containing the letter B, platelet-rich plasma injection will be done in area B and normal saline injection in area A.
Main outcome variables
Improvement of severity of macular amyloidosis lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220808055641N4
Registration date:2024-02-03, 1402/11/14
Registration timing:prospective
Last update:2024-02-03, 1402/11/14
Update count:0
Registration date
2024-02-03, 1402/11/14
Registrant information
Name
Alireza Jafarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 890 7445
Email address
alirezajafarzadeh8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-09, 1402/11/20
Expected recruitment end date
2024-06-09, 1403/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of platelet-rich plasma injection in combination with tranexamic acid compared with tranexamic acid injection alone inthe treatment of macular amyloidosis
Public title
Efficacy of platelet-rich plasma injection in combination with tranexamic acid compared with tranexamic acid injection alone inthe treatment of macular amyloidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of macular amyloidosis
Age above 18 years old
Exclusion criteria:
Pregnancy
Breastfeeding
Coagulation disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the study, the affected area in each patient is divided into two parts and the areas are named as A and B. In both mentioned areas, tranexamic acid ampoules are injected intradermally. Next, two envelopes are presented to each of the patients, which contain the letters A and B, and the patient is not aware of the contents of the envelope. By choosing the envelope containing the letter A, platelet-rich plasma is injected at a distance of 1 cm from each other in area A. . In area B, normal saline injection is performed as a control group. Also, if you choose the envelope containing the letter B, platelet-rich plasma injection will be done in area B and normal saline injection in area A. All patients are re-injected with tranexamic acid in the mentioned areas in the 4th and 8th weeks, and in the 4th week, in addition to tranexamic acid, platelet-rich plasma and normal saline are injected in the two previously injected areas.Finally, the evaluation of lesions in the 12th week of
The study will begin.
Blinding (investigator's opinion)
Double blinded
Blinding description
At the beginning of the study, the affected area in each patient is divided into two parts and the areas are named as A and B. In both mentioned areas, tranexamic acid ampoules are injected intradermally. Next, two envelopes are presented to each of the patients, which contain the letters A and B, and the patient is not aware of the contents of the envelope.
Placebo
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- faculty of medicine
Street address
No 6, Avesta Ave, Azadi Blvd, Tehran
City
Tehran
Province
Mazandaran
Postal code
1345643546
Approval date
2024-01-03, 1402/10/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.546
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
improvement of macular amyloidosis
Timepoint
The beginning of the study and 1 month after the start of the study and 3 months after the start of the study
Method of measurement
sonography;visioface;biometery;cutometery,physician global assessment score;patient global assessment score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:injection of tranexamic acid in combination with platelet rich plasma and evaluation in 4 weeks, 8 weeks and 12 weeks
Category
Treatment - Drugs
2
Description
Control group: injection of tranexamic acid in combination with normal saline and evaluation in 4 weeks, 8 weeks and 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Akram training and treatment center
Full name of responsible person
Alireza Jafarzadeh
Street address
Rasoul akram, mazyar mansouri Ave, sattarkhan Blvd, Tehran Town
City
Tehran
Province
Tehran
Postal code
1346544457
Phone
+98 919 890 7445
Email
alirezajafarzadeh8@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Nilforoushzadeh
Street address
No. 4, Maryam Alley, Kamraniyeh St., Tehran
City
Tehran
Province
Tehran
Postal code
1234356765
Phone
+98 21 2665 7541
Email
alirezajafarzadeh8@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Iran University of Medical Sciences
Full name of responsible person
Alireza Jafarzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.6, ahmadzadeh ardabili Ave, Avesta Blvd, Azadi Blvd, Tehran Town
City
Tehran
Province
Tehran
Postal code
6567634523
Phone
+98 919 890 7445
Email
alirezajafarzadeh8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Jafarzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.6, ahmadzadeh ardabili Ave, Avesta Blvd, Azadi Blvd, Tehran Town
City
Tehran
Province
Tehran
Postal code
13244357653
Phone
+98 919 890 7445
Email
alirezajafarzadeh8@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Jafarzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.6, ahmadzadeh ardabili Ave, Avesta Blvd, Azadi Blvd, Tehran Town
City
Tehran
Province
Tehran
Postal code
13244543654
Phone
+98 919 890 7445
Email
alirezajafarzadeh8@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
En After the completion of the study, all patient data will be shared through the article after de-identification.
When the data will become available and for how long
Access to data starts immediately after the publication of the article.
To whom data/document is available
There are no restrictions on people's access to data.
Under which criteria data/document could be used
There is no restriction on the type of data usage.
From where data/document is obtainable
rasool-E-akram hospital, niyayesh Ave, satar khan Blvd, Tehran
What processes are involved for a request to access data/document
After receiving the email from the applicant, the data will be sent within a maximum of 6 months.