Comparative evaluation of the safety and efficacy of botulinum toxin type A (product of Imen Vaccine Alborz CO) in comparison with Dysport (standard treatment) for treating glabellar rhytids in people with moderate to severe glabellar rhytids.
Comparative evaluation of the safety and efficacy of botulinum toxin type A (product of Imen Vaccine Alborz CO) in comparison with Dysport (standard treatment) for treating moderate-to-severe glabellar rhytids
Design
Two arm parallel group randomized double blind active controlled trial with 140 participants
Settings and conduct
This clinical study is conducted on volunteers at the Center for research and training in skin diseases and leprosy. Before the intervention skin photograph will be taken for full face and frown lines, as well as blood and urine lab tests for the participants, then according to randomization code, the subjects will be treated with the relative drug (test or control).
14, 30, 60 and 90 days later the skin photography will be repeated. Also, the lab tests will be repeated in the last visit.
Participants/Inclusion and exclusion criteria
Men and women 18 to 75 years with moderate-to-severe glabellar rhytids who have not history of treatment with botulinum toxin in face area within the past 6 months and history of injectable filler, chemical peels and laser treatment within the past year and they have not also sensitivity to botulinum toxin
Intervention groups
Group 1: botulinum toxin type A (product of Imen Vaccine Alborz CO)
500iu vial, intra muscular injection, 40-60iu in 2.5 cc normal saline in 3 to 5 point in frontal area in one visit
Group 2: Dysport (product of IPSEN)
500iu vial, intra muscular injection, 40-60iu in 2.5 cc normal saline in 3 to 5 point in frontal area in one visit
Main outcome variables
Subjects with improvement in GLSS in month 4
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N8
Registration date:2019-01-30, 1397/11/10
Registration timing:prospective
Last update:2019-01-30, 1397/11/10
Update count:1
Registration date
2019-01-30, 1397/11/10
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the safety and efficacy of botulinum toxin type A (product of Imen Vaccine Alborz CO) in comparison with Dysport (standard treatment) for treating glabellar rhytids in people with moderate to severe glabellar rhytids.
Public title
evaluation the effect of botulinum toxin type A for treating frown lines
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women with 18 to 75 years old
mild to moderate Glabellar Lines
signing informed consent form
Exclusion criteria:
Hypersensitivity to botulinum toxin or other components of formulation
History of treatment with botulinum toxin in face area within the past 6 months
History of using aminoglycosides, penicillin, kinin, chloroquine,Calcium Channel Blockers, warfarin and aspirin
History of injectable filler, chemical peels and laser treatment of any type within the past year
Significant scarring ,skin disorder or wound infection in the facial area
Neuro-muscular disorders like miastenia gravis, iron lambert , ALS
Significant face asymmetry
Any active, chronic and recurrent infection
Pregnancy/ breast feeding
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Random Chain Generation performed using by R-CRAN version 3.2.3. We used randomized permutations, blocks (the size of each block is 4) for a total of 140 volunteers (1: 1 ratio). The codes will be labeled on the drugs.
After ensuring the volunteer's eligibility and signing the informed consent form, a nurse will receive a code from the study site which will be used for random allocation of the drug to the candidate. The related drug will be injected for the volunteer. In this way, the volunteers fall into one of the two intervention groups and the volunteers' group and the type of drug they receive will not be disclosed to researchers or the study team.
Blinding (investigator's opinion)
Double blinded
Blinding description
All volunteers will be examined by a specialist physician at the site of the study and the injection will be done at five points of the face muscles after examining eligibility for entry. Due to availability of the drug in the study site and sticking the research label on the medications and injections by the doctor, volunteer and the doctor will not be aware of the type of drug. The ICF has also met the purpose of the study and the volunteer knows that it will be randomly assigned to one of the two treatment groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-12-27, 1397/10/06
Ethics committee reference number
IR.TUMS.VCR.REC.1397.708
Health conditions studied
1
Description of health condition studied
skin rejuvenation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
glabellar line severity scale
Timepoint
before intervention and 3, 7, 14, 30, 60, 90 and 120 days later
Method of measurement
physical examination
Secondary outcomes
1
Description
patients satisfaction
Timepoint
30 and 120 days after intervention
Method of measurement
Questioner
Intervention groups
1
Description
Intervention group: botulinum toxin type A (product of Imen Vaccine Alborz CO) 500iu vial, intra muscular injection, 40-60iu in 2.5 cc normal saline in 3 to 5 point in frontal area in one visit
Category
Treatment - Drugs
2
Description
Control group: Dysport (product of IPSEN) 500iu vial, intra muscular injection, 40-60iu in 2.5 cc normal saline in 3 to 5 point in frontal area in one visit
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research and Training in Skin Diseases & Leprosy Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Street address
Taleghani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 8190
Email
dermalab@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Imen vaccine alborz Company
Full name of responsible person
Maryam Amini Pouya
Street address
Khaje Nasir Toosi Avenue
City
karaj
Province
Alborz
Postal code
3331495894
Phone
+98 26 4533 4189
Email
info@imenvaccine.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Imen vaccine alborz Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
415 Taleghani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 982188978190
Email
aniseh_samadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Professor of Dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
415 Taleghani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 982188978190
Email
firozali@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
415 Taleghani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 982188978190
Email
aniseh_samadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available