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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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History
# Registration date Revision Id
3 2024-05-18, 1403/02/29 303894
2 2023-10-17, 1402/07/25 282727
1 2023-10-09, 1402/07/17 281339
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  • Protocol summary

    Two arm parallel group randomized double blind active controlled trial with 140 participants. 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 146 volunteers (1: 1 ratio).
    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).
    مطالعه بالینی فاز 3 تصادفی سازی شده، دو بازویی، موازی، دو سوکور، کنترل فعال با 146 نفر شرکت کننده. ساخت توالی عددی تصادفی داوطلبان توسط نرم افزار R-CRAN نسخه ی 3.2.3 به انجام می رسد. با استفاده از بلوک های جایگشت شده تصادفی، بلوکهایی (اندازه هر بلوک 4 است) برای مجموع 146 داوطلب (با نسبت 1:1) ساخته خواهد شد.
    مطالعه بالینی فاز 3 تصادفی سازی شده، دو بازویی، موازی، دو سوکور، کنترل فعال با 146 نفر شرکت کننده. ساخت توالی عددی تصادفی داوطلبان توسط نرم افزار R-CRAN نسخه ی 4.2.1 به انجام می رسد. با استفاده از بلوک های جایگشت شده تصادفی، بلوکهایی (اندازه هر بلوک 4 است) برای مجموع 146 داوطلب (با نسبت 1:1) ساخته خواهد شد.
    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). 30, 60, 90 and 120 days later the skin photography will be repeated
    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
    این مطالعه ی بالینی بر روی داوطلبان در مرکز آموزش و پژوهش بیماری های پوست و جذام انجام می شود. قبل از مطالعه عکس برداری از کل صورت و خطوط اخم و همچنین آزمایشات خونی و ادراری برای شرکت کنندگان انجام می شود. سپس افراد با توجه به کد راندومیزاسیون مورد درمان با داروی مورد نظر (داروی مورد آزمایش یا داروی کنترل) قرار می گیرند. 30، 60 ،90 و 120 روز بعد عکس برداری تکرار می شوند
    این مطالعه ی بالینی بر روی داوطلبان در مرکز آموزش و پژوهش بیماری های پوست و جذام انجام می شود. قبل از مطالعه عکس برداری از کل صورت و خطوط اخم و همچنین آزمایش ادرار برای شرکت کنندگان انجام می شود. سپس افراد با توجه به کد راندومیزاسیون مورد درمان با داروی مورد نظر (داروی مورد آزمایش یا داروی کنترل) قرار می گیرند. 14، 30، 60 ،90 و 120 روز بعد عکس برداری تکرار می شوند
    Men and women 18 to 65 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
    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
    زنان و مردان با سن 18 الي 65 سال که داراي درجات متوسط تا شدید خط اخم (Glabellar Lines) در حالت اخم باشند و فرم رضایت نامه آگاهانه را امضا کرده باشند همچنین تحت درمان با فیلر، پيلينگ شیمیایی و لیزر طی 12 ماه گذشته و بوتاکس طی 6 ماه گذشته را نداشته باشند و به سم بوتولینوم حساسیت نداشته باشند
    معیارهای ورود: زنان و مردان با سن 18 الي 65 سال که داراي درجات متوسط تا شدید خط اخم (Glabellar Lines) در حالت ماکسیمم اخم باشند و فرم رضایت نامه آگاهانه را امضا کرده باشند معیارهای عدم ورود: درمان پیشین در ناحیه glabellar طی 12 ماه قبل از تصادفی‌سازی سابقه جراحی پلاستیک صورت، لیفت ابرو و dermal resurfacing آلرژی به نوروتوکسین بوتولینوم
    درصد داوطلبان با بهبود در خطوط اخم در حالت اخم
    درصد داوطلبان با بهبود در خطوط اخم در حالت ماکسیمم اخم

  • General information

    Triple blinded
    Double blinded
    1
    empty
    To edit some things like sponsor name and R-CRAN version
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    جهت ویرایش بعضی موارد مانند نام اسپانسر و نسخه نرم افزار R-CRAN
    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
    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
    History of treatment with botulinum toxin in face area within the past 6 months
    History of injectable filler, chemical peels and laser treatment of any type within the past year
    Neuro-muscular disorders like miastenia gravis, iron lambert , ALS
    Significant scarring ,skin disorder or wound infection in the facial area
    History of using aminoglycosides, penicillin, kinin, chloroquine,Calcium Channel Blockers, warfarin and aspirin
    Any active, chronic and recurrent infection
    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
    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
    درمان پیشین با توکسین بوتولینوم در نواحی صورت طی 6 ماه اخیر
    سابقه هر گونه تزریق فیلر، پيلينگ شیمیایی، لیزر در 12 ماه اخیر
    ابتلا به بیماری هایی که می تواند فعالیت عصبی عضلانی را تحت تاثیر قرار دهد( مثل میانستی گراویس، ALS یا ایتون لامبرت)
    وجود زخم ها یا اسکارها یا ضایعات نواحی مورد درمان
    مصرف داروهاي آمینوگلایکوزیدها، پنیسیلامین، کینین، کلروکین، هیدروکسی کلروکین، Calcium Channel Blockers، وارفارین و آسپیرین
    وجود هر گونه عفونت فعال یا راجعه در نواحی تزریق
    خانم باردار یا شیرده
    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
    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 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.
    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.
    ساخت توالی عددی تصادفی داوطلبان توسط نرم افزار R-CRAN نسخه ی 3.2.3 به انجام می رسد. با استفاده از بلوک های جایگشت شده تصادفی، بلوکهایی (اندازه هر بلوک 4 است) برای مجموع 146داوطلب (با نسبت 1:1) ساخته خواهد شد. کدهای ساخته شده روی دارو های مطالعه برچسب گذاری خواهد شد. دارو ها بعد از کد گذاری در سایت مطالعه قرار خواهد گرفت. بعد از حصول اطمینان از واجد شرایط بودن داوطلب و امضای فرم رضایت اگاهانه، طی تماس تلفنی پرستار از سایت مطالعه کدی را دریافت می کند که برای تخصیص تصادفی دارو به داوطلب از آن استفاده خواهد شد. سپس داروی متناظر آن کد برای داوطلب تزریق می شود. بدین صورت داوطلبان در یکی از دو گروه مداخله قرار می گیرند. گروه داوطلبان و نوع داروی دریافتی آنان، به محققان و تیم مجری مطالعه، فاش نخواهد شد.
    ساخت توالی عددی تصادفی داوطلبان توسط نرم افزار R-CRAN نسخه ی 4.2.1 به انجام می رسد. با استفاده از بلوک های جایگشت شده تصادفی، بلوکهایی (اندازه هر بلوک 4 است) برای مجموع 146داوطلب (با نسبت 1:1) ساخته خواهد شد. کدهای ساخته شده روی دارو های مطالعه برچسب گذاری خواهد شد. دارو ها بعد از کد گذاری در سایت مطالعه قرار خواهد گرفت. بعد از حصول اطمینان از واجد شرایط بودن داوطلب و امضای فرم رضایت اگاهانه، طی تماس تلفنی پرستار از سایت مطالعه کدی را دریافت می کند که برای تخصیص تصادفی دارو به داوطلب از آن استفاده خواهد شد. سپس داروی متناظر آن کد برای داوطلب تزریق می شود. بدین صورت داوطلبان در یکی از دو گروه مداخله قرار می گیرند. گروه داوطلبان و نوع داروی دریافتی آنان، به محققان و تیم مجری مطالعه، فاش نخواهد شد.
    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
    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
    تمامی داوطلبان بعد از بررسی واجد شرایط بودن برای ورود به مطالعه، توسط پزشک متخصص در سایت مطالعه ویزیت شده و تزریق دارو در پنج نقطه از عضلات صورت انجام خواهد شد. و با توجه به موجود بودن دارو در استوک دارویی سایت و چسباندن برچسب پژوهشی روی داروها و تزریق توسط پزشک، داوطلب و پزشک از نوع داروی تزریقی مطلع نخواهند شد. در ICF به طور کامل هدف انجام مطالعه قید شده است و داوطلب می داند که به صورت تصادفی در یکی از دو گروه درمانی قرار خواهد گرفت
    تمامی داوطلبان بعد از بررسی واجد شرایط بودن برای ورود به مطالعه، توسط پزشک متخصص در سایت مطالعه ویزیت شده و تزریق دارو در سه تا پنج نقطه از عضلات صورت انجام خواهد شد. و با توجه به موجود بودن دارو در استوک دارویی سایت و چسباندن برچسب پژوهشی روی داروها و تزریق توسط پزشک، داوطلب و پزشک از نوع داروی تزریقی مطلع نخواهند شد. در ICF به طور کامل هدف انجام مطالعه قید شده است و داوطلب می داند که به صورت تصادفی در یکی از دو گروه درمانی قرار خواهد گرفت

  • Primary outcomes

    #1
    درصد داوطلبان با بهبود در خطوط اخم در حالت اخم
    درصد داوطلبان با بهبود در خطوط اخم در حالت حداکثر اخم
    before intervention and 30 days later
    30 days after intervention
    قبل از مداخله و 30 روز پس از مداخله
    30 روز پس از مداخله

  • Secondary outcomes

    #1
    Before intervention 30, 60, 90 and 120 days later
    Before intervention, 14, 30, 60, 90 and 120 days later
    قبل از مداخله، 30، 60، 90 و 120 روز پس از مداخله
    قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
    #2
    درصد داوطلبان با بهبود در خطوط اخم در حالت اخم بر اساس SSA
    درصد داوطلبان با بهبود در خطوط اخم در حالت ماکسیمم اخم بر اساس SSA
    Before intervention 30, 60, 90 and 120 days later
    Before intervention, 14, 30, 60, 90 and 120 days later
    قبل از مداخله، 30، 60، 90 و 120 روز پس از مداخله
    قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
    #3
    Before intervention 30, 60, 90 and 120 days later
    Before intervention, 14, 30, 60, 90 and 120 days later
    قبل از مداخله، 30، 60، 90 و 120 روز پس از مداخله
    قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
    Subject Self Assessment (SSA)
    Subject Self-Assessment (SSA)
    #4
    empty
    Percentage of subjects with improvement in Glabellar Lines at maximum frown
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    درصد داوطلبان با بهبود در خطوط اخم در حالت حداکثر اخم
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    on days 14, 60, 90 and 120 after receiving treatment.
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    در روز 14، 60، 90 و 120 پس از دریافت دارو
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    GLSS (Glabellar Lines Severity Score)
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    GLSS (Glabellar Lines Severity Score)
    #5
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    Received accumulative dose (total dose received at visit 1 and touch-up visit)
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    دوز تجمعی دریافت‌شده (مجموع دوز دریافتی در ویزیت 1 و ویزیت Touch-up)
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    14 days after intervention
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    14 روز پس از مداخله
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    Calculation of total dose received at visit 1 and touch-up visit)
    empty
    محاسبه مجموع دوز دریافتی در ویزیت 1 و ویزیت Touch-up
    #6
    empty
    onset of action at rest
    empty
    زمان شروع اثربخشی (onset of action) درحالت استراحت
    empty
    14 days after intervention
    empty
    14 روز پس از مداخله
    empty
    Subject Self-Assessment (SSA)
    empty
    بر اساس ارزیابی داوطلب (SSA)
    #7
    empty
    onset of action at maximum frown
    empty
    زمان شروع اثربخشی (onset of action) درحالت ماکسیمم اخم
    empty
    14 days after intervention
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    14 روز پس از مداخله
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    Subject Self-Assessment (SSA)
    empty
    بر اساس ارزیابی داوطلب (SSA)
    #8
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    Assessment of the occurrence of adverse events
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    ارزیابی بروز رخدادهای نامطلوب
    empty
    On days 14, 60, 90 and 120 after receiving treatment
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    قبل از مداخله، 14، 30، 60، 90 و 120 روز پس از مداخله
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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.
    empty
    تمامی رخدادهای نامطلوب اعم از رخدادهای نامطلوب مرتبط و غیر مرتبط، جدی (مانند دیس‌فاژیا، ضعف عضلانی و واکنش‌های آلرژیک) و غیر جدی ثبت و گزارش خواهند شد.

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Zist orchid pharmed Company
    Name of organization / entity - Persian: شرکت زیست ارکید فارمد
    Full name of responsible person - English: Araz Sabzevari
    Full name of responsible person - Persian: آراز سبزواری
    Street address - English: No 42,Atar squer, Atar street, Valie-asr street,Vanak squer
    Street address - Persian: میدان ونک، خیابان ولیعصر، خیابان عطار، میدان عطار، پلاک ۴۲
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1994766411
    Phone: +98 21 4347 3000
    Fax:
    Email: ask@orchidpharmed.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Espad pharmed Company
    Name of organization / entity - Persian: شرکت اسپاد فارمد
    Full name of responsible person - English: Hooshyar Gholami
    Full name of responsible person - Persian: هوشیار غلامی
    Street address - English: Unit 5, 3rd Floor, No. 56, Azimi St., Nafisi St., Ekbatan
    Street address - Persian: اکباتان، خیابان نفیسی، خیابان عظیمی، پلاک56، طبقه 3 واحد 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1393833166
    Phone: +98 21 4463 1124
    Fax:
    Email: info@espadpharmed.com
    Web page address:
    Zist orchid pharmed Company
    Espad pharmed Company
    شرکت زیست ارکید فارمد
    شرکت اسپاد فارمد

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
To edit some things like sponsor name and R-CRAN version
Acronym
IRCT registration information
IRCT registration number: IRCT20150101020514N23
Registration date: 2023-10-09, 1402/07/17
Registration timing: prospective

Last update: 2023-10-22, 1402/07/30
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 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
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, 60, 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, 60, 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, 60, 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, 60, 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, 60, 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 to 5 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 to 5 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
Full name of responsible person
Aniseh Samadi
Street address
No. 415, Naderi Aven., Taleghani St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Espad pharmed Company
Full name of responsible person
Hooshyar Gholami
Street address
Unit 5, 3rd Floor, No. 56, Azimi St., Nafisi St., Ekbatan
City
Tehran
Province
Tehran
Postal code
1393833166
Phone
+98 21 4463 1124
Email
info@espadpharmed.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Espad pharmed Company
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
Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
MD and Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Dermatologist and professor of Tehran Univercity of Medical Sciences.
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Naderi Aven., Taleghani St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
firozali@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir

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
Not applicable
Data Dictionary
Not applicable
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