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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.

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History
# Registration date Revision Id
2 2019-05-07, 1398/02/17 89739
1 2019-01-30, 1397/11/10 77472
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  • Protocol summary

    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.
    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, 90 and 120 days later the skin photography will be repeated.
    این مطالعه ی بالینی بر روی داوطلبان در مرکز آموزش و پژوهش بیماری های پوست و جذام انجام می شود. قبل از مطالعه عکس برداری از کل صورت و خطوط اخم و همچنین آزمایشات خونی و ادراری برای شرکت کنندگان انجام می شود. سپس افراد با توجه به کد راندومیزاسیون مورد درمان با داروی مورد نظر (داروی مورد آزمایش یا داروی کنترل) قرار می گیرند. 14، 30، 60 و 90 روز بعد عکس برداری تکرار می شوند همچنین آزمایشات در ویزیت آخر تکرار خواهد شد.
    این مطالعه ی بالینی بر روی داوطلبان در مرکز آموزش و پژوهش بیماری های پوست و جذام انجام می شود. قبل از مطالعه عکس برداری از کل صورت و خطوط اخم و همچنین آزمایشات خونی و ادراری برای شرکت کنندگان انجام می شود. سپس افراد با توجه به کد راندومیزاسیون مورد درمان با داروی مورد نظر (داروی مورد آزمایش یا داروی کنترل) قرار می گیرند. 14، 30، 60 ،90 و 120 روز بعد عکس برداری تکرار می شوند
    Subjects with improvement in GLSS in month 4
    Subjects with improvement in GLSS one month (30 days) after treatment
    درصد داوطلبان با بهبود در خط اخم بر اساس GLSS چهار ماه بعد
    درصد داوطلبان با بهبود در خط اخم بر اساس GLSS یک ماه (30 روز) بعد از تزریق

  • General information

    Double blinded
    Triple blinded
    1
    empty
    empty

  • Secondary outcomes

    #1
    patients satisfaction
    Percentage of subjects with improvement in Glabellar Lines at maximum frown
    رضایت بیمار
    درصد داوطلبان با بهبود در Glabellar Lines در حالت اخم
    30 and 120 days after intervention
    before intervention and 60, 90 and 120 days later
    30 و 120 روز پس از مداخله
    قبل از مداخله و 60، 90 و 120 روز پس از مداخله
    Questioner
    GLSS
    پرسشنامه
    GLSS
    #2
    empty
    Percentage of subjects with improvement in Glabellar Lines at resting
    empty
    درصد داوطلبان با بهبود در Glabellar Lines در حالت استراحت
    empty
    before intervention and 60, 90 and 120 days later
    empty
    قبل از مداخله و 60، 90 و 120 روز پس از مداخله
    empty
    GLSS
    empty
    GLSS
    #3
    empty
    Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring
    empty
    درصد داوطلبان با بهبود در Glabellar Lines در حالت اخم بر اساس SSA
    empty
    before intervention and 30 and 120 days later
    empty
    قبل از مداخله و 30 و 120 روز پس از مداخله
    empty
    Subject Self Assessment (SSA)
    empty
    میزان رضایت شخصی (SSA )
    #4
    empty
    Percentage of subjects with improvement in Glabellar Lines at rest using SSA scoring
    empty
    درصد داوطلبان با بهبود در Glabellar Lines در حالت استراحت بر اساس SSA
    empty
    before intervention and 30 and 120 days later
    empty
    قبل از مداخله و 30 و 120 روز پس از مداخله
    empty
    Subject Self Assessment (SSA)
    empty
    میزان رضایت شخصی (SSA )
    #5
    empty
    The onset and duration of the effect of two groups
    empty
    زمان شروع اثر و ماندگاری اثر داروی مداخله در دو گروه
    empty
    Days 3, 7, 14, 30, 60, 90, 120 after treatment
    empty
    روزهای 3، 7، 14، 30، 60، 90 و 120 پس از درمان
    empty
    Clinical assessment
    empty
    مطالعه بالینی
    #6
    empty
    Adverse effects
    empty
    عوارض جانبی
    empty
    Days 3, 7, 14, 30, 60, 90, 120 after treatment
    empty
    روزهای 3، 7، 14، 30، 60، 90 و 120 پس از درمان
    empty
    Clinical assessment
    empty
    مطالعه بالینی

  • Recruitment centers

    #1
    Name of recruitment center - English: Center for Research and Training in Skin Diseases & Leprosy Tehran University of Medical Sciences
    Name of recruitment center - Persian: مرکز آموزش و پژوهش بیماری های پوست و جذام. دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Alireza Firooz
    Full name of responsible person - Persian: علیرضا فیروز
    Street address - English: Taleghani Avenue
    Street address - Persian: خیابان طالقانی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1416613675
    Phone: +98 21 8897 8190
    Fax:
    Email: dermalab@tums.ac.ir
    Web page address:
    Name of recruitment center - English: Center for Research and Training in Skin Diseases & Leprosy Tehran University of Medical Sciences
    Name of recruitment center - Persian: مرکز آموزش و پژوهش بیماری های پوست و جذام. دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Alireza Firooz
    Full name of responsible person - Persian: علیرضا فیروز
    Street address - English: No 415- Taleghani Avenue
    Street address - Persian: خیابان طالقانی- پلاک 415
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1416613675
    Phone: +98 21 8897 8190
    Fax:
    Email: dermalab@tums.ac.ir
    Web page address:

Protocol summary

Study aim
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, 90 and 120 days later the skin photography will be repeated.
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 one month (30 days) after treatment

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: 2019-05-12, 1398/02/22
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
  • Data analyser
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)
Triple 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
Percentage of subjects with improvement in Glabellar Lines at maximum frown
Timepoint
before intervention and 60, 90 and 120 days later
Method of measurement
GLSS

2

Description
Percentage of subjects with improvement in Glabellar Lines at resting
Timepoint
before intervention and 60, 90 and 120 days later
Method of measurement
GLSS

3

Description
Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring
Timepoint
before intervention and 30 and 120 days later
Method of measurement
Subject Self Assessment (SSA)

4

Description
Percentage of subjects with improvement in Glabellar Lines at rest using SSA scoring
Timepoint
before intervention and 30 and 120 days later
Method of measurement
Subject Self Assessment (SSA)

5

Description
The onset and duration of the effect of two groups
Timepoint
Days 3, 7, 14, 30, 60, 90, 120 after treatment
Method of measurement
Clinical assessment

6

Description
Adverse effects
Timepoint
Days 3, 7, 14, 30, 60, 90, 120 after treatment
Method of measurement
Clinical assessment

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
No 415- 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
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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