Objectives: To assess the effect of botulinum toxin A injection versus no intervention on clinical sign in women with facial flushing
Design: a before after clinical trial.
Setting and conduct: The eligible women facial flushing who will refer to dermatology clinic of Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) facial flushing; (b) female sex.
Exclusion criteria: (a) carcinoid syndrome or thyroid medullary cell carcinoma; (b) pregnancy or breast feeding; (c) systemic diseases.
Intervention: A single dose intradermal injection of 2 IU botulinum toxin A (Neuronox) in every 1 cm in each chin to a maximum of 30 IU.
Control: Compared to before intervention.
Primary outcome: Clinical sign of flashing before and one month after intervention using DLQI questionnaire.
Secondary outcome: (a) unintended facial paralysis or partial paralysis of lower eyelid one month after intervention through history taking; (b) strabismus one month after intervention through history taking.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503129014N59
Registration date:2015-04-25, 1394/02/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-25, 1394/02/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of botulinum toxin A injection versus no intervention on clinical sign in women with facial flushing: a before after clinical trial
Public title
Effect of botulinum toxin A injection versus no intervention on clinical sign in women with facial flushing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) facial flushing; (b) female sex.
Exclusion criteria: (a) carcinoid syndrome or thyroid medullary cell carcinoma; (b) pregnancy or breast feeding; (c) systemic diseases.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: This is a before after trial therefore randomization is impossible.
Blinding: Blinding is impossible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan
City
Hamadan
Postal code
6517838695
Approval date
2015-04-11, 1394/01/22
Ethics committee reference number
P/16/35/9/6
Health conditions studied
1
Description of health condition studied
Flushing
ICD-10 code
R23.2
ICD-10 code description
Flushing
Primary outcomes
1
Description
Clinical sign of flashing
Timepoint
before and one month after intervention
Method of measurement
using DLQI questionnaire
Secondary outcomes
1
Description
unintended facial paralysis or partial paralysis of lower eyelid
Timepoint
one month after intervention
Method of measurement
through history taking
2
Description
strabismus
Timepoint
one month after intervention
Method of measurement
through history taking
Intervention groups
1
Description
A single dose intradermal injection of 2 IU botulinum toxin A (Neuronox) in every 1 cm in each chin to a maximum of 30 IU
Category
Treatment - Drugs
2
Description
Compared to before intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr Gholamreza Eshghi
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Leila Khezrian
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
khezrian.leila@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Gholamreza Eshghi
Position
Dermatologist
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
gholamrezaeshghi58@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor of Epidemiology
Other areas of specialty/work
Street address
Department of Epidemiology & Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)