compression of changing facial emotion recognition before and after of botulinum toxin type A injection in facial muscle of patients who came for cosmetic aims with multi modal emotion recognition test (MERT)
Design
A non-randomized before after clinical trial of 68 patients, enrolled in February 2018, and followed for two months
Settings and conduct
patients who come to dermatological clinics of kerman university of medical sciences and health services
Participants/Inclusion and exclusion criteria
patients above 18 years old with frown lines in forehead area who come for first time of injection of botulinum toxin type A are include and pregnant women, allergy to drug, history of trauma or recent surgery in forehead area, presence of dementia or psychiatric problems and visual or speech abnormalities are exclude from the study
Intervention groups
eligible patients who come to cosmetic clinic for the first time of botulinum toxin injection are evaluate with MERT test before starting the study; then 8 weeks after completion of treatment, the change of emotion recognition's are evaluate.
Main outcome variables
evaluation and assessment of changing in emotion recognition before and after of botulinum toxin injection with MERT test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150410021677N3
Registration date:2018-02-06, 1396/11/17
Registration timing:registered_while_recruiting
Last update:2018-02-06, 1396/11/17
Update count:0
Registration date
2018-02-06, 1396/11/17
Registrant information
Name
Kaveh Shafiei
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 5785
Email address
k_shafiei@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-05, 1396/11/16
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
changing facial emotion recognition before and after cosmetic botulinum toxin type A injection
Public title
Efficacy of Botulinum Toxin in Facial Emotion Recognition
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
first time of botulinum toxin injection
age above 18 years
presence of frown lines in forehead
Exclusion criteria:
allergy to botulinum toxin
pregnancy
history of facial trauma
history of surgery in forehead area of face
history of dementia and psychiatric disorder
visual and speech abnormalities
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
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 Kerman university of medical Sciences
Street address
Kosar square, shafa hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Approval date
2018-01-17, 1396/10/27
Ethics committee reference number
IR.KMU.REC.1396.208296000763
Health conditions studied
1
Description of health condition studied
Disorder of the skin and subcutaneous tissue, unspecified
ICD-10 code
L98.9
ICD-10 code description
Disorder of the skin and subcutaneous tissue, unspecified
Primary outcomes
1
Description
incidence frown line in forehad
Timepoint
before intervention and 2 weeks after injection botulinum
Method of measurement
visual evaluation
Secondary outcomes
1
Description
evaluation of emotion recognition
Timepoint
before intervention, 8 after intervention
Method of measurement
multi modal emotion recognition test (MERT)
Intervention groups
1
Description
Intervention group:patients with frown lines in forehead area. 500 unit of botulinum toxin type A(Dysport,Epsen,UK)dissolve in 0.9%injectable NACL solution and inject 20Unit to the procerus muscle,35 U bilaterally to the corrugator muscles and 15U in lateral sentiment of orbicularis occuli.The MERT score calculate before and 8 week after injection.MERT test of the Swiss centre for affective science at the university of Geneva,during 45 minutes,test participitanta asked to choose the emotion presented by actors in different modalities(still picture,video only,audio only and audio-visual),At the end of calculate the score.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatological Clinic of Kerman University of medical sciences
Full name of responsible person
Kaveh Shafiei
Street address
kosar square.,shafa hospital
City
kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3212 4727
Email
amirsherafat@mail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kaveh shafiei
Street address
Kosar square., shafa hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3212 4727
Email
amirsherafat@mail.com
Grant name
Kerman university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Kaveh shafiei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kosar square., shafa hospital
City
Kerman
Province
Kerman
Postal code
768751151
Phone
+98 34 3212 4727
Email
amirsherafat@mail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kaveh shafiei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kosar square., shafa hospital
City
Kerman
Province
Kerman
Postal code
768751151
Phone
+98 34 3212 4727
Email
amirsherafat@mail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kaveh shafiei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kosar square., shafa hospital
City
Kerman
Province
Kerman
Postal code
768751151
Phone
+98 34 3212 4727
Email
amirsherafat@mail.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
All collected deidentified of IPD
When the data will become available and for how long
Starting 6 month after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Only for scentific research
From where data/document is obtainable
Doctor Amir sherafat, neurology resident of kerman university of medical sciences,amirsherafat@mail.com,
Doctor Kaveh shafiee,neurology assitant professor of kerman university medical sciences.kshafiee@gmail.com,
What processes are involved for a request to access data/document
Documents will be send 2weeks after direct request by email to the corresponding author