Evaluation of carboxytherapy as a new treatment for Striae
Design
After considering inclusion criteria 15 individuals has been chosen. patients treatment was accomplished during 8 session with 1 week interval and before every session and also 3 months after last session a picture took from patient,s lesion with a camera which fixed in a specified distance ,same setting and same light .At the end of the study every patient,s picture evaluated according to the scores and by 2 blind dermatologist .also patient's satisfactory scales about the treatment has been considered
Settings and conduct
study population is patients who refer to Ghaem and Emam Reza hospital to treat their Striae Alba and Rubra in sima Teb clinic.
Participants/Inclusion and exclusion criteria
inclusion criteria: Individuals with Striae.
Exclusion criteria: imaging dissatisfaction, Absence of reference in particular time in order to cure and follow up, Severe respiratory insufficiency and severe renal insufficiency, chronic renal fail, severe anemia, Acute inflamation or skin disease at injection site, inflamatory and infectious involvment of skin such as herpes Poor control diabet Mental weakness, epilepsy Pregnancy and lactation Pationts treated with carbonic anhydrase inhibitors like acetozolamide
Intervention groups
15 patients referring for treatment of Striae with carboxytherapy
Main outcome variables
decrease in diameter and repigmentation of Striae Alba and rubra
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140414017271N3
Registration date:2018-01-29, 1396/11/09
Registration timing:registered_while_recruiting
Last update:2018-01-29, 1396/11/09
Update count:0
Registration date
2018-01-29, 1396/11/09
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
Expected recruitment start date
2017-12-20, 1396/09/29
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of carboxytherapy in Striae َalba and rubra treatment
Public title
Evaluation of carboxytherapy in Striae treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with Striae
Exclusion criteria:
imaging dissatisfaction
Absence of reference in particular time in order to cure and follow up
Severe respiratory insufficiency and severe renal insufficiency, chronic renal fail,severe anemia
Acute inflamation or skin disease at injection site, inflamatory and infectious involvment of skin such as herpes
Poor control diabet
Mental weakness,epilepsy
Pregnancy and lactation
Pationts treated with carbonic anhydrase inhibitors like acetozolamide
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
9177899191
Approval date
2017-12-20, 1396/09/29
Ethics committee reference number
IR.MUMS.fm.REC.1396.360
Health conditions studied
1
Description of health condition studied
Striae
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae
Primary outcomes
1
Description
diameter of Striae Alba and rubra
Timepoint
every week for 8 weeks and 3 months after treatment
Method of measurement
scoring by 2 dermatologist and patients pleasure according 0-10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with Striae under treatment with 10 session carboxytherapy every week
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza and Ghaem hospital
Full name of responsible person
Yalda Nahidi
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2040
Email
nahidiy@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Yalda Nahidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 5732
Email
nahidiy@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Yalda Nahidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 5732
Email
nahidiy@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Yalda Nahidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 5732
Email
nahidiy@mums.ac.ir
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
All data can be shared after patients are made unidentifiable
When the data will become available and for how long
Data can be accessible 6 months after results are published
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes
Under which criteria data/document could be used
Carrying out analysis on data is permitted
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.