Protocol summary
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Study aim
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The onset of action and safety ِDyston during 14 days after injection will be evaluated in this study.
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Design
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The single-arm, open-label phase IV clinical trial on 184 volunteers
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Onset of action; treatment-emergent adverse events of Dyston within 14 days
General information
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Reason for update
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Study completion
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180515039672N3
Registration date:
2020-05-21, 1399/03/01
Registration timing:
prospective
Last update:
2020-09-01, 1399/06/11
Update count:
1
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Registration date
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2020-05-21, 1399/03/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-05-21, 1399/03/01
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Expected recruitment end date
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2020-06-21, 1399/04/01
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Actual recruitment start date
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2020-05-31, 1399/03/11
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Actual recruitment end date
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2020-06-15, 1399/03/26
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Trial completion date
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2020-06-29, 1399/04/09
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Scientific title
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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
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Public title
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The onset of action and safety of Dyston in glabellar lines improvement
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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4
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Groups that have been masked
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No information
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Sample size
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Target sample size:
184
Actual sample size reached:
184
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-07, 1399/02/18
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Ethics committee reference number
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IR.TUMS.VCR.REC.1399.345
Health conditions studied
1
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Description of health condition studied
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Glabellar frown lines
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ICD-10 code
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R23.4
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ICD-10 code description
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Changes in skin texture
Primary outcomes
1
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Description
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The onset of action
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Timepoint
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Daily (immediately after injection till 14 days)
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Method of measurement
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Average (day)
2
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Description
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Adverse events
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Timepoint
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Daily (immediately after injection till 14 days)
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Method of measurement
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Percentage
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Imen Vaccine Alborz
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available