Protocol summary
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Study aim
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A phase III, randomized, tow armed, double-blinded, parallel, active-controlled, non-inferiority clinical trial to compare efficacy and safety of Abobotulinum toxin A(Espad Pharmed) versus Abobotulinum toxin A(Dysport®, Ipsen Co.) for correction of moderate to severe glabellar line
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Design
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Two arm parallel group randomized double blind active controlled trial with 140 participants. Random Chain Generation performed using by R-CRAN version 4.2.1. We used randomized permutations, blocks (the size of each block is 4) for a total of 146 volunteers (1: 1 ratio).
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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 urine lab test 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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Inclusion criteria:
Men and women 18 to 65 years with moderate-to-severe glabellar lines at maximum frown
Exclusion criteria:
Previous treatment in the glabellar area within 12 months prior to randomization
History of facial plastic surgery, eyebrow lift and dermal resurfacing
Allergies to botulinum neurotoxin
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Intervention groups
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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
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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Main outcome variables
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Percentage of subjects with improvement in Glabellar Lines at maximum frown
General information
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Reason for update
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Delete the 60th day visit and making some changes in exclusion criteria
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150101020514N23
Registration date:
2023-10-09, 1402/07/17
Registration timing:
prospective
Last update:
2024-06-04, 1403/03/15
Update count:
2
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Registration date
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2023-10-09, 1402/07/17
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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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2023-10-22, 1402/07/30
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Expected recruitment end date
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2024-07-20, 1403/04/30
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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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A phase III, randomized, two armed, double-blinded, parallel, active-controlled, non-inferiority clinical trial to compare efficacy and safety of Abobotulinum toxin A(Espad Pharmed) versus Abobotulinum toxin A(Dysport®, Ipsen Co.) for correction of moderate to severe glabellar line
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Public title
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Clinical trial to compare efficacy and safety of Abobotulinum toxin A(Espad Pharmed) versus Abobotulinum toxin A(Dysport®, Ipsen Co.)
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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 65 years old
Mild to moderate Glabellar Lines
Signing informed consent form
Exclusion criteria:
Previous treatment in the glabellar area within 12 months prior to randomization
History of facial plastic surgery, eyebrow lift and dermal resurfacing
History of inserting non-absorbent substances or surgery to remove the glabellar muscle.
Severe atrophy in glabellar area
Planned Facial Cosmetic Surgery (such as filler injection, chemical peeling and laser) Using products that cause skin remodeling or active changes on the forehead area and History of any cosmetic surgery in glabellar area in the last 6 months
Active infection in injection area
Facial expressions that can impair safety or efficacy outcomes.
Neuromuscular connectivity disorders
Current treatment with drugs that interfere with neuromuscular function.
Allergies to botulinum neurotoxin as well as injectable fillers in the facial area
Participate in another research study on botulinum neurotoxin products and fillers in the last 6 months
Any other condition that may expose a risk to the volunteer during the study or disrupt safety or efficacy outcomes
Pregnancy/ breast feeding
History of eyebrow tattoo or any other procedure in the eyebrow area during the last month
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
146
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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 4.2.1. We used randomized permutations, blocks (the size of each block is 4) for a total of 146 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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Double 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 3-5 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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2023-09-12, 1402/06/21
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1402.330
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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Percentage of subjects with improvement in Glabellar Lines at maximum frown
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Timepoint
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30 days after intervention
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Method of measurement
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GLSS (Glabellar Lines Severity Score)
Secondary outcomes
1
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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, 14, 30, 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 maximum frown using SSA scoring
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Timepoint
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Before intervention, 14, 30, 90 and 120 days later
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Method of measurement
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Subject Self Assessment (SSA)
3
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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, 14, 30, 90 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 maximum frown
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Timepoint
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on days 14, 90 and 120 after receiving treatment.
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Method of measurement
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GLSS (Glabellar Lines Severity Score)
5
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Description
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Received accumulative dose (total dose received at visit 1 and touch-up visit)
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Timepoint
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14 days after intervention
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Method of measurement
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Calculation of total dose received at visit 1 and touch-up visit)
6
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Description
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onset of action at rest
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Timepoint
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14 days after intervention
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Method of measurement
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Subject Self-Assessment (SSA)
7
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Description
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onset of action at maximum frown
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Timepoint
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14 days after intervention
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Method of measurement
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Subject Self-Assessment (SSA)
8
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Description
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Assessment of the occurrence of adverse events
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Timepoint
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On days 14, 90 and 120 after receiving treatment
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Method of measurement
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All adverse events including related and unrelated adverse events, serious (such as dysphagia, muscle weakness and allergic reactions) and non-serious events will be recorded and reported.
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 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 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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Espad pharmed 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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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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Not applicable
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Data Dictionary
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Not applicable