Protocol summary

Study aim
evaluation the safety of Glabellar injection of botulinum toxin type "A" of in 3 doses in healthy volunteers
Design
Phase I clinical trial; single center on healthy volunteers. participants in 3 groups will receive 3 diiferent dose.
Settings and conduct
This study will be conducted in Shahid Solaymani clininical trial center affliated to Baqiyatallah hospital on healthy volunteers; three groups of 5 persons will recieve 12.5, 25 and 50 units of botulinum toxin type "A" and safety and efficacy of the product will be evaluated.
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
Intervention group 1: Deep 12.5 units single dose IM injection of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company in 3 points in glabelar area; Intervention group 2: Deep 25 units single dose IM injection of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company in 3 points in glabelar area; Intervention group 3: Deep 50 units single dose IM injection of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company in 3 points in glabelar area.
Main outcome variables
Dermal reactions in injection area and other places; neurologic reactions in head and neck; clinical and paraclinical reactions related to injection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101012004920N10
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
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety study on botulinum toxin type "A" of Plasma Darman Sarve Sepid Company
Public title
Safety study on botulinum toxin type "A" of Plasma Darman Sarve Sepid Company
Purpose
Other
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
1
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Vice-chancellor in Research Affairs, Shahid Beheshti University of Medi
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
Healthy volunteers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Any serious dermal reaction in injection area
Timepoint
Days: 0, 1, 3, 14 and 28
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)

2

Description
Any serious dermal reaction in the places other than injection area
Timepoint
Days: 0, 1, 3, 14 and 28
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)

3

Description
Neurological adverse event in head and face related to intervention
Timepoint
Days: 0, 1, 3, 14 and 28
Method of measurement
Physical examination

4

Description
Serious clinical adverse event in head and neck related to intervention
Timepoint
Days: 0, 1, 3, 14 and 28
Method of measurement
Physical examination

5

Description
Any abnormal Lab. findings related to intervention
Timepoint
Days: 0, 1, 3, 14 and 28
Method of measurement
Lab tests

6

Description
Systemic serious adverse event related to intervention i.e. Dysphagia, muscular weakness, Allergic reactions
Timepoint
Days: 0, 1, 3, 14 and 28
Method of measurement
Physical examination and lab. tests

Secondary outcomes

1

Description
Changes in score of Glabellar Line in maximum frown
Timepoint
Days: 0 , 14 and 28
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 , 14 and 28
Method of measurement
Glabellar Line Scale (GLS) and Glabellar Line Severity Score (GLSS)

3

Description
Patients self assessment
Timepoint
Days: 0 , 14 and 28
Method of measurement
Subject Satisfaction Scale (SSS)

4

Description
Percent of participants that has 2 or more score reduction on GLSS
Timepoint
Days: 14 and 28
Method of measurement
Glabellar Line Severity Score (GLSS)

Intervention groups

1

Description
Intervention group: Deep 12.5 units single dose IM injection of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company in 3 points in glabelar area
Category
Treatment - Drugs

2

Description
Intervention group: Deep 25 units single dose IM injection of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company in 3 points in glabelar area
Category
Treatment - Drugs

3

Description
Intervention group: Deep 50 units single dose IM injection of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company in 3 points in glabelar area
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Solaymani Clinical Trial Center
Full name of responsible person
Dr. Reza Robati
Street address
Baqiyatallah Hospital, Mollasadra Street
City
Tehran
Province
Tehran
Postal code
1537114359
Phone
+98 21 8805 0435
Email
rezarobati@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Plasma Darman Sarve Sepid
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
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
Dermatology Research Center, Shohadae Tajrish Hospital, Qods Sqr.
City
Tehran
Province
Tehran
Postal code
1989934148
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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