The Phase IV study for assessment of the onset of action and Treatment EmergentAdverse Events of Dyston (Botulinum Toxin Type A- ImenVaccine Co.) in Glabellar Lines Improvement
The onset of action and safety ِDyston during 14 days after injection will be evaluated in this study.
Design
The single-arm, open-label phase IV clinical trial on 184 volunteers
Settings and conduct
The study site is in the skin operation room of Razi hospital in Tehran. After taking the informed consent and evaluating the eligibility criteria and the injection, the physician records the volunteer's information in the "Case Report Form". Also, a diary card for a 14-day following up will be given to them.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male/female age of 18-75 years with moderate to severe glabellar lines at maximum frown.
Exclusion criteria: History of aesthetic procedures on the glabellar area within the last 12 months, the medical condition that may affect neuromuscular function, history of facial nerve palsy, history of the eyelid or eyebrow ptosis, pregnant or lactating females
Intervention groups
Intramuscular injection of Dyston (botulinum toxin type A- Imen vaccine Co.) into 3 to 5 injection sites of the glabellar area at the first visit.
Main outcome variables
Onset of action; treatment-emergent adverse events of Dyston within 14 days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180515039672N3
Registration date:2020-05-21, 1399/03/01
Registration timing:registered_while_recruiting
Last update:2020-05-21, 1399/03/01
Update count:1
Registration date
2020-05-21, 1399/03/01
Registrant information
Name
Maryam Amini Pouya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6696
Email address
maryam.aminipooya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Phase IV study for assessment of the onset of action and Treatment EmergentAdverse Events of Dyston (Botulinum Toxin Type A- ImenVaccine Co.) in Glabellar Lines Improvement
Public title
The onset of action and safety of Dyston in glabellar lines improvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 75 year old volunteer
Moderate to severe glabellar lines at maximum frown
Signed an informed consent form
Being agree with 14-day follow up
Exclusion criteria:
Hypersensitivity to botulinum toxin or any other ingredients in the formulation
Taking the following medicines: aminoglycosides, penicillamine, quinine, chloroquine, hydroxychloroquine, calcium channel blockers, Anticoagulants (warfarin and aspirin)
Any aesthetic surgery (e.g. fillers injection, chemical peeling, laser) or any other materials causing remodeling of the skin or active changes in the glabellar area within the last 12 months
Previous history of any surgery in the facial muscles or scars in the glabellar area and the surrounding areas (including eyebrows)
The medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
History of facial nerve palsy
Marked facial asymmetry
History of the eyelid or eyebrow ptosis due to the facial muscle palsy
Any active infection or acute skin disease in the injection sites
Pregnant or lactating females
Age
From 18 years old to 75 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
184
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 Tehran University of Medical sciences
Street address
Vice-Chancellor in Research Affairs-Tehran University of Medical Science, 6th floor, near Qods st, keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417614418
Approval date
2020-05-07, 1399/02/18
Ethics committee reference number
IR.TUMS.VCR.REC.1399.345
Health conditions studied
1
Description of health condition studied
Glabellar frown lines
ICD-10 code
R23.4
ICD-10 code description
Changes in skin texture
Primary outcomes
1
Description
The onset of action
Timepoint
Daily (immediately after injection till 14 days)
Method of measurement
Average (day)
2
Description
Adverse events
Timepoint
Daily (immediately after injection till 14 days)
Method of measurement
Percentage
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intramuscular injection of 0.2 to 0.3 milliliter from 500 unit vial of Dyston (botulinum toxin type A-Imen Vaccine Alborz) which is reconstituted in 2.5 milliliters of normal saline, into 3 to 5 injection sites in glabellar muscles at the first visit.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Amir Hooshang Ehsani
Street address
Vahdat Eslami St., Vahdat Eslami Sq.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
ehsanih@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Imen Vaccine Alborz
Full name of responsible person
Sajad Saeedifar
Street address
No. 110, Khajenasireddin Tousi Street
City
Nazar Abad
Province
Alborz
Postal code
3331495900
Phone
+98 942 600 1123
Email
s.saeedifar@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
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
Arta Zist Pharmed
Full name of responsible person
Maryam Amini Pouya
Position
Medical supervisor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Atam building, Niro street, South Jannat Abad
City
Tehran
Province
Tehran
Postal code
1473913108
Phone
0098219426001123
Email
m.amini@artapharmed.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi hospital
Full name of responsible person
Amir Hooshang Ehsani
Position
Specialist dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami street., Vahdat Eslami square
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Email
ehsanih@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arta Zist Pharmed
Full name of responsible person
Elnaz Zabihi Eidgahi
Position
Medical Expert
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Atam building, Niro street, South Jannat Abad
City
Tehran
Province
Tehran
Postal code
1473913108
Phone
0098219426001123
Email
e.zabihi@artapharmed.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available