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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General information
To edit some things like sponsor name and R-CRAN version
Delete the 60th day visit and making some changes in exclusion criteria
To editDelete the 60th day visit and making some things like sponsor name and R-CRAN versionchanges in exclusion criteria
جهت ویرایش بعضی موارد مانند نام اسپانسر و نسخه نرم افزار R-CRAN
حذف ویزیت روز 60 و ایجاد بعضی تغییرات در شرایط عدم ورود به مطالعه
جهت ویرایشحذف ویزیت روز 60 و ایجاد بعضی موارد مانند نام اسپانسر و نسخه نرم افزار R-CRANتغییرات در شرایط عدم ورود به مطالعه
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
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
Participate in another research study
Any other condition that may expose a risk to the volunteer during the study or disrupt safety or efficacy outcomes
Pregnancy/ breast feeding
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
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
درمان پیشین در ناحیه glabellar طی 12 ماه قبل از تصادفی‌سازی
سابقه جراحی پلاستیک صورت، لیفت ابرو و dermal resurfacing
سابقه قرار دادن مواد غیرقابل جذب یا عمل جراحی برای برداشتن عضلات ناحیه glabellar
آتروفی شدید در ناحیه glabellar
جراحی زیبایی برنامه‌ریزی شده صورت
عفونت فعال در نواحی تزریق
حالات صورت که می‌تواند نتایج ایمنی یا اثربخشی را مختل کند
اختلالات اتصال عصبی-عضلانی
درمان فعلی با داروهایی که با عملکرد عصبی-عضلانی تداخل دارند
آلرژی به نوروتوکسین بوتولینوم
شرکت در مطالعه تحقیقاتی دیگر
هر وضعیت دیگری که ممکن است طی مطالعه خطری برای داوطلب ایجاد کند یا نتایج ایمنی یا اثربخشی را مختل کند
بارداری یا شیردهی
درمان پیشین در ناحیه glabellar طی 12 ماه قبل از تصادفی‌سازی
سابقه جراحی پلاستیک صورت، لیفت ابرو و dermal resurfacing
سابقه قرار دادن مواد غیرقابل جذب یا عمل جراحی برای برداشتن عضلات ناحیه glabellar
آتروفی شدید در ناحیه glabellar
جراحی زیبایی برنامه‌ریزی شده صورت (مثل تزریق فیلر، پيلينگ شیمیایی و لیزر) یا استفاده از فرآورده هایی که باعث remodeling پوست و یا تغییر فعال روی ناحیه پیشانی شود و سابقه هر گونه جراحي زیبایی در ناحیه خط اخم در 6 ماه اخیر
عفونت فعال در نواحی تزریق
حالات صورت که می‌تواند نتایج ایمنی یا اثربخشی را مختل کند
اختلالات اتصال عصبی-عضلانی
درمان فعلی با داروهایی که با عملکرد عصبی-عضلانی تداخل دارند
آلرژی به نوروتوکسین بوتولینوم و همچنین فیلرهای تزریقی در منطقه صورت
شرکت در مطالعه تحقیقاتی دیگر ﺑﺮ ﺭﻭﯼ ﻓﺮﺁﻭﺭﺩﻩ ﻫﺎﯼ ﺑﻮﺗﻮﻟﯿﻨﻮﻡ ﻧﻮﺭﻭﺗﻮﮐﺴﯿﻦ و ﻓﯿﻠﺮها طی 6 ماه اخیر
هر وضعیت دیگری که ممکن است طی مطالعه خطری برای داوطلب ایجاد کند یا نتایج ایمنی یا اثربخشی را مختل کند
بارداری یا شیردهی
سابقه تتو ابرو یا هر پروسجر دیگری در ناحیه ابرو طی یک ماه اخیر
درمان پیشین در ناحیه glabellar طی 12 ماه قبل از تصادفی‌سازی سابقه جراحی پلاستیک صورت، لیفت ابرو و dermal resurfacing سابقه قرار دادن مواد غیرقابل جذب یا عمل جراحی برای برداشتن عضلات ناحیه glabellar آتروفی شدید در ناحیه glabellar جراحی زیبایی برنامه‌ریزی شده صورت (مثل تزریق فیلر، پيلينگ شیمیایی و لیزر) یا استفاده از فرآورده هایی که باعث remodeling پوست و یا تغییر فعال روی ناحیه پیشانی شود و سابقه هر گونه جراحي زیبایی در ناحیه خط اخم در 6 ماه اخیر عفونت فعال در نواحی تزریق حالات صورت که می‌تواند نتایج ایمنی یا اثربخشی را مختل کند اختلالات اتصال عصبی-عضلانی درمان فعلی با داروهایی که با عملکرد عصبی-عضلانی تداخل دارند آلرژی به نوروتوکسین بوتولینوم و همچنین فیلرهای تزریقی در منطقه صورت شرکت در مطالعه تحقیقاتی دیگر ﺑﺮ ﺭﻭﯼ ﻓﺮﺁﻭﺭﺩﻩ ﻫﺎﯼ ﺑﻮﺗﻮﻟﯿﻨﻮﻡ ﻧﻮﺭﻭﺗﻮﮐﺴﯿﻦ و ﻓﯿﻠﺮها طی 6 ماه اخیر هر وضعیت دیگری که ممکن است طی مطالعه خطری برای داوطلب ایجاد کند یا نتایج ایمنی یا اثربخشی را مختل کند بارداری یا شیردهی سابقه تتو ابرو یا هر پروسجر دیگری در ناحیه ابرو طی یک ماه اخیر
Secondary outcomes
#1
Before intervention, 14, 30, 60, 90 and 120 days later
Before intervention, 14, 30, 90 and 120 days later
Before intervention, 14, 30, 60, 90 and 120 days later
قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
قبل از مداخله، 14، 30، 90 و 120 روز پس از مداخله
قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
#2
Before intervention, 14, 30, 60, 90 and 120 days later
Before intervention, 14, 30, 90 and 120 days later
Before intervention, 14, 30, 60, 90 and 120 days later
قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
قبل از مداخله، 14، 30، 90 و 120 روز پس از مداخله
قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
#3
Before intervention, 14, 30, 60, 90 and 120 days later
Before intervention, 14, 30, 90 and 120 days later
Before intervention, 14, 30, 60, 90 and 120 days later
قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
قبل از مداخله، 14، 30، 90 و 120 روز پس از مداخله
قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
#4
on days 14, 60, 90 and 120 after receiving treatment.
on days 14, 90 and 120 after receiving treatment.
on days 14, 60, 90 and 120 after receiving treatment.
در روز 14، 60، 90 و 120 پس از دریافت دارو
در روز 14، 90 و 120 پس از دریافت دارو
در روز 14، 60، 90 و 120 پس از دریافت دارو
#5
On days 14, 60, 90 and 120 after receiving treatment
On days 14, 90 and 120 after receiving treatment
On days 14, 60, 90 and 120 after receiving treatment
قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
قبل از مداخله، 14، 90 و 120 روز پس از مداخله
قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
Intervention groups
#1
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
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
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
گروه مداخله: سم آبوبوتولینوم نوع A (شرکت اسپاد فارمد) تزریق عضلانی 40-60 واحد حل شده در 2.5 میلی لیتر نرمال سالین تزریقی در 3 تا 5 نقطه از عضلات پیشانی در یک ویزیت
گروه مداخله: سم آبوبوتولینوم نوع A (شرکت اسپاد فارمد) تزریق عضلانی 40-60 واحد حل شده در 2.5 میلی لیتر نرمال سالین تزریقی در 3 نقطه از عضلات پیشانی در یک ویزیت
گروه مداخله: سم آبوبوتولینوم نوع A (شرکت اسپاد فارمد) تزریق عضلانی 40-60 واحد حل شده در 2.5 میلی لیتر نرمال سالین تزریقی در 3 تا 5 نقطه از عضلات پیشانی در یک ویزیت
#2
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
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
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
گروه کنترل: دیسپورت (IPSEN) تزریق عضلانی به میزان 40-60 واحد بین المللی حل شده در 2.5 میلی لیتر نرمال سالین تزریقی در 3 تا 5 نقطه از عضلات پیشانی در ویزیت اول
گروه کنترل: دیسپورت (IPSEN) تزریق عضلانی به میزان 40-60 واحد بین المللی حل شده در 2.5 میلی لیتر نرمال سالین تزریقی در 3 نقطه از عضلات پیشانی در ویزیت اول
گروه کنترل: دیسپورت (IPSEN) تزریق عضلانی به میزان 40-60 واحد بین المللی حل شده در 2.5 میلی لیتر نرمال سالین تزریقی در 3 تا 5 نقطه از عضلات پیشانی در ویزیت اول
Protocol summary
Study aim
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
Design
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).
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 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
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
Percentage of subjects with improvement in Glabellar Lines at maximum frown
General information
Reason for update
Delete the 60th day visit and making some changes in exclusion criteria
Acronym
IRCT registration information
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
Registration date
2023-10-09, 1402/07/17
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
2023-10-22, 1402/07/30
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Clinical trial to compare efficacy and safety of Abobotulinum toxin A(Espad Pharmed) versus Abobotulinum toxin A(Dysport®, Ipsen Co.)
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double 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 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
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of medical school-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
2023-09-12, 1402/06/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.330
Health conditions studied
1
Description of health condition studied
skin rejuvenation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of subjects with improvement in Glabellar Lines at maximum frown
Timepoint
30 days after intervention
Method of measurement
GLSS (Glabellar Lines Severity Score)
Secondary outcomes
1
Description
Percentage of subjects with improvement in Glabellar Lines at resting
Timepoint
Before intervention, 14, 30, 90 and 120 days later
Method of measurement
GLSS
2
Description
Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring
Timepoint
Before intervention, 14, 30, 90 and 120 days later
Method of measurement
Subject Self Assessment (SSA)
3
Description
Percentage of subjects with improvement in Glabellar Lines at rest using SSA scoring
Timepoint
Before intervention, 14, 30, 90 and 120 days later
Method of measurement
Subject Self-Assessment (SSA)
4
Description
Percentage of subjects with improvement in Glabellar Lines at maximum frown
Timepoint
on days 14, 90 and 120 after receiving treatment.
Method of measurement
GLSS (Glabellar Lines Severity Score)
5
Description
Received accumulative dose (total dose received at visit 1 and touch-up visit)
Timepoint
14 days after intervention
Method of measurement
Calculation of total dose received at visit 1 and touch-up visit)
6
Description
onset of action at rest
Timepoint
14 days after intervention
Method of measurement
Subject Self-Assessment (SSA)
7
Description
onset of action at maximum frown
Timepoint
14 days after intervention
Method of measurement
Subject Self-Assessment (SSA)
8
Description
Assessment of the occurrence of adverse events
Timepoint
On days 14, 90 and 120 after receiving treatment
Method of measurement
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
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 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 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 and leprosy, Tehran University of Medical Sciences