Protocol summary
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Study aim
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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 moderate-to-severe glabellar rhytids
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Design
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Two arm parallel group randomized double blind active controlled trial with 140 participants
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Subjects with improvement in GLSS one month (30 days) after treatment
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-01-30, 1397/11/10
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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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2019-02-20, 1397/12/01
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Expected recruitment end date
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2019-11-22, 1398/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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evaluation the effect of botulinum toxin type A for treating frown lines
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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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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2-3
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
140
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Parallel
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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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2018-12-27, 1397/10/06
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Ethics committee reference number
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IR.TUMS.VCR.REC.1397.708
Health conditions studied
1
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Description of health condition studied
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skin rejuvenation
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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glabellar line severity scale
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Timepoint
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before intervention and 3, 7, 14, 30, 60, 90 and 120 days later
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Method of measurement
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physical examination
Secondary outcomes
1
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Description
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Percentage of subjects with improvement in Glabellar Lines at maximum frown
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Timepoint
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before intervention and 60, 90 and 120 days later
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Method of measurement
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GLSS
2
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Description
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Percentage of subjects with improvement in Glabellar Lines at resting
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Timepoint
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before intervention and 60, 90 and 120 days later
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Method of measurement
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GLSS
3
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Description
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Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring
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Timepoint
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before intervention and 30 and 120 days later
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Method of measurement
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Subject Self Assessment (SSA)
4
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Description
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Percentage of subjects with improvement in Glabellar Lines at rest using SSA scoring
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Timepoint
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before intervention and 30 and 120 days later
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Method of measurement
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Subject Self Assessment (SSA)
5
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Description
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The onset and duration of the effect of two groups
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Timepoint
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Days 3, 7, 14, 30, 60, 90, 120 after treatment
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Method of measurement
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Clinical assessment
6
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Description
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Adverse effects
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Timepoint
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Days 3, 7, 14, 30, 60, 90, 120 after treatment
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Method of measurement
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Clinical assessment
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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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 Company
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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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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not 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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available