Protocol summary

Study aim
The study aim is efficacy and safety of 40 -60 unit injection of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company for treatment of Glabellar Line and comparing it with Dysport® of Ipsen Co.
Design
Randomized clinical trial, phase 3, double blind with control group in 3 centers
Settings and conduct
This study will be conducted in 3 sites in Tehran, Iran (Shohadae Tajrish and Loghman Hakim hospitals Skin Research Centers and Dermatology clinic of Baqiyatallah hospital). The efficacy and safety of 40 - 60 units deep muscular injection of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company in 3 points of glabellar region will be compared with Dysport® brand.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Both genders; Age between 25- 55 years old; General health condition by medical history and physical examination; Informed consent to participate in the study. Exclusion criteria: Unwillingness to participate in the study; Not regularly participate in clinical visits and evaluations; Participate in any other clinical trial during the study; Happening sever hypersensitivity reactions related to botulinum neurotoxin till 30 minutes after injection; Happening serious unwanted event that participant needs to exit study by investigator's decision.
Intervention groups
Deep muscular injection of 40 -60 unit of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company in intervention group and same dose and manner of Dysport® of Ipsen Co. in control group.
Main outcome variables
Percent of participants that has 2 or more score reduction on GLSS; possible side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101012004920N11
Registration date: 2024-08-07, 1403/05/17
Registration timing: prospective

Last update: 2024-08-07, 1403/05/17
Update count: 0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
Ramin Heshmat
Name of organization / entity
Chronic Diseases Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0086
Email address
rheshmat@tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2026-04-21, 1405/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy and safety of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company with Dysport® of Ipsen Co. in the treatment of the moderate to severe glabellar lines: a randomized, active controlled, double-blind, non-inferiority phase 3 trial
Public title
Comparison the efficacy and safety of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company with Dysport® of Ipsen Co. in treatment of glabellar lines
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both genders Age between 25- 55 years old General health condition by medical history and physical examination Moderate to severe Glabellar lines by GLS and GLSS criteria Informed consent to participate in the study
Exclusion criteria:
Conditions that alter the safety results, like: eyelid ptosis or eyebrow ptosis; facial nerve paralysis; notable face asymmetry; overt dermatochalasis; deep dermal scar; thick sebaceous skin Neuromuscular junction diseases i.e. Myasthenia Gravis; Eaton Lembert syndrome; Amyotrophic Lateral Sclerosis or other disease that alter neuromuscular function Sever muscular atrophy or weakness in injection site Previous injection of Botulinum neurotoxin in last 6 months Participation in other trials related to Botulinum neurotoxin and fillers History for hypersensitivity reaction to filler or gel injection or laser therapy in face area History for Filler or gel injection in face History for face plastic surgery i.e. tissue augmentation, eyebrow lifting or dermal resurfacing History for cosmetic surgery (chemical peeling, laser) using materials that cause skin remodeling or active changes in forehead and near area (in 6 months). History for eyebrow tattoo or other procedure in last month History for insertion unabsorbable material or surgery to remove Corrugator، Procerus، Supercilli Depressor or combination therapy Previous hypersensitivity or sever event after similar botulinum neurotoxin administration Previous scar or surgery in eyebrow or forehead Acute infection or dermal disease in injection site Sever cardiovascular, respiratory disease or asthma Planned cosmetic surgery during study Intention to participate in other trial during study Taking medications i.e. for Alzheimer disease (galantamine, rivastigmine, tacrine), Myasthenia gravis (ambenonium, pyridostigmine) and anticoagulants (warfarin, aspirin) Taking medications: Aminoglycosides (gentamycin, ...), penicillamine, quinine, chloroquine, hydroxychloroquine, Calcium channel blockers one week before study Pregnancy or breast feeding Unwillingness to participate in the study Not regularly participate in clinical visits and evaluations Participate in any other clinical trial during the study Happening sever hypersensitivity reactions related to botulinum neurotoxin till 30 minutes after injection Happening serious unwanted event that participant needs to exit study by investigator's decision Happening new or chronic condition that participant needs to exit study by investigator's decision
Age
From 25 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 202
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed separately and independent for each recruitment center. For randomization, permuted balanced random blocks with size of 4 will be administered, in each block 2 people will receive botulinum toxin type "A" of Plasma Darman Sarve Sepid Company and 2 others will receive Dysport® of Ipsen Co.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, researchers and evaluators are blind to study intervention product.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences, Research Ethics Committee of Vice-chancellor in Rese
Street address
Shahid Beheshti University of Medical Sciences, Arabi st., Daneshjo Blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-07-21, 1403/04/31
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.176

Health conditions studied

1

Description of health condition studied
Glabellar lines
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Percent of participants that has 2 or more score reduction on GLSS in maximum frown
Timepoint
Days: 0 and 30
Method of measurement
Glabellar Line Severity Score

Secondary outcomes

1

Description
Changes in score of Glabellar Line in maximum frown
Timepoint
Days: 0, 30, 90 and 120
Method of measurement
Glabellar Line Scale (GLS) and Glabellar Line Severity Score (GLSS)

2

Description
Changes in score of Glabellar Line in relax position
Timepoint
Days: 0, 30, 90 and 120
Method of measurement
Glabellar Line Scale (GLS) and Glabellar Line Severity Score (GLSS)

3

Description
En Patients self assessment
Timepoint
Days: 0, 30, 90 and 120
Method of measurement
فا Subject Satisfaction Scale (SSS)

4

Description
proportion of persons that their response rate to injection (frown and relax) have been saved till day 120
Timepoint
Days: 0 and 120
Method of measurement
Glabellar Line Scale (GLS) and Glabellar Line Severity Score (GLSS)

5

Description
Total dose of injection in units (sum of days: 0 and 14)
Timepoint
Days: 0 and 14
Method of measurement
Patients' medical records

6

Description
Any serious dermal reaction in injection area
Timepoint
Days: 0 and 14
Method of measurement
NCH & NIH guideline (Cancer Therapy Evaluation Program 13 Revised March 23, 1998 Common Toxicity Criteria, Version 2.0 DCTD, NCI, NIH, DHHS March 1998)

7

Description
Any serious dermal reaction in the places other than injection area
Timepoint
Days: 0 and 14
Method of measurement
NCH & NIH guideline (Cancer Therapy Evaluation Program 13 Revised March 23, 1998 Common Toxicity Criteria, Version 2.0 DCTD, NCI, NIH, DHHS March 1998)

8

Description
Neurological adverse event in head and neck related to intervention
Timepoint
Study duration
Method of measurement
Physical examination

9

Description
Serious clinical adverse event in head and face related to intervention
Timepoint
Study duration
Method of measurement
Physical examination

10

Description
Systemic serious adverse event related to intervention i.e. Dysphagia, muscular weakness, Allergic reactions
Timepoint
Days: 0 and 14
Method of measurement
NCH & NIH guideline (Cancer Therapy Evaluation Program 13 Revised March 23, 1998 Common Toxicity Criteria, Version 2.0 DCTD, NCI, NIH, DHHS March 1998)

Intervention groups

1

Description
Intervention group: Deep muscular injection of 40 - 60 unit of botulinum toxin type "A" by Plasma Darman Sarve Sepid Company in 3 points of glabellar area
Category
Treatment - Drugs

2

Description
Control group: Deep muscular injection of 40 - 60 unit of of Dysport® by Ipsen Co. in 3 points of glabellar area
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Skin Research Center, Shohadae Tajrish Hospital
Full name of responsible person
Dr. Reza Robati
Street address
Shohadae Tajrish Hospital, Qods Sqr.
City
Tehran
Province
Tehran
Postal code
19899 34148
Phone
+98 21 2274 1507
Email
src@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Skin Research Center, Loghman Hakim Hospital
Full name of responsible person
Dr. Mohamad Rahmati Roodsari
Street address
Makhsoos St., Lashgar Cross
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
src@sbmu.ac.ir

3

Recruitment center
Name of recruitment center
Baqiyatallah Hospital, Dermatology Clinic
Full name of responsible person
Dr. Seyyed Masoud Davoudi
Street address
Sheykh Bahaei Cross, Molla Sadra Ave.
City
Tehran
Province
Tehran
Postal code
1537114359
Phone
+98 21 8805 0435
Email
src@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Plasma Darman Sarve Sepid Company
Full name of responsible person
Mr. Hossein Salem
Street address
3rd floor, No. 200, Sadra Medical Complex, Molla Sadra Street
City
Tehran
Province
Tehran
Postal code
1993645488
Phone
+98 21 8860 0370
Email
info@sarvsepid.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Plasma Darman Sarve Sepid 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
Dr. Ramin Heshmat
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Chronic Diseases Research Center, Next to Shariati Hospital, Jalal al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8822 0086
Email
rheshmat@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Reza Robati
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Skin Research Center, Shohadae Tajrish Hospital, Qods Sqr.
City
Tehran
Province
Tehran
Postal code
19899 34148
Phone
+98 21 2274 1507
Email
src@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Heshmat
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Chronic Diseases Research Center, Next to Shariati Hospital, Jalal al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8822 0086
Email
rheshmat@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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