The objective of this study is to evaluate the safety , efficacy and dose finding of Masport® manufactured by Masoondarou Co. to treatment of glabellar facial lines. The trial is a monocentric study . Inclusion criteria: Male or females age 18 - 60 years with moderate to severe glabellar lines; exclusion criteria: evidence of any unusual condition in volunteers, evidence of pregnancy before administration of product and abnormal results of paraclinical tests. 12 volunteers will be enrolled in the study and each of the volunteers monitored for a maximum 4 months. Intervention is Masport® 500 unit vial manufactured by Masoondarou Co.. Volunteers will be injected by 1 dose of product in 5 sites. Primary endpoints includes efficacy measurements are the investigator’s rating of glabellar line severity at maximum frown at day 30 post-injection, Subject’s global assessment of change in appearance of glabellar lines at day 30 post-injection and occurrence any local and systemic adverse effects. A secondary efficacy endpoint is the investigator’s rating of glabellar line severity at rest at day 30 post-injection
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201154536N2
Registration date:2012-01-30, 1390/11/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-01-30, 1390/11/10
Registrant information
Name
Naser Mohammadpour
Name of organization / entity
Masoon Darou Biopharmaceutical Co.
Country
Iran (Islamic Republic of)
Phone
+98 26 1667 0349
Email address
info@masoondarou.net
Recruitment status
Recruitment complete
Funding source
Masoondarou Biopharmaceutical Co. & Research Deuty of Ministry of Health, Islamic Repubic of Iran
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-08-20, 1391/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study for safety and efficacy of intramuscular Administration of MASPORT® manufactured by Masoondarou Co. (phase 1 and 2)
Public title
Study for effects of Masport in adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: male or females age between 18 to 60 years old with moderate to severe glabellar facial lines
Exclusion criteria: evidence of any unusual condition in volunteer, i.e.: severe allergic reactions, need for use of corticosteroids, evidence of pregnancy before administration of products and abnormal results of paraclinical tests (leukocytopenia , leukocytosis , thrombocytopenia , anemia , hyperkalemia , hypokalemia , hypernatremia , hyponatremia) .
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
12
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 Deputy of Tehran Medical University
Street address
6 Floor , Central Office of University , Keshavarz Blv.
City
Tehran
Postal code
Approval date
2012-01-03, 1390/10/13
Ethics committee reference number
2200/130/ص/90
Health conditions studied
1
Description of health condition studied
Glabellar Facial lines
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Occurrence any local and systemic adverse effects
Timepoint
At day 3, 7, 14, 30, 60, 90 and 120 post-injection
Method of measurement
Clinical examination , blood and urine analysis
2
Description
Subject Global Assessment of Change (SGA)
Timepoint
At days 0 , 3 , 7 , 14 , 30 , 60 and 120 Post-injection
Method of measurement
Subject’s global assessment
3
Description
Rating of glabellar line severity at maximum frown
Timepoint
At days 3, 7, 14 and 30 post-injection
Method of measurement
Rating of glabellar line severity
Secondary outcomes
1
Description
Rating of glabellar line severity at rest
Timepoint
At day 30 post-injection
Method of measurement
Rating of glabellar line severity
Intervention groups
1
Description
Masport® 500 unit vial manufactured by Masoondarou Co. Each vial contain 500 unit botulinum type a toxin , 0.5 mg human albumin and 2.5 mg lactose . The dose of this product for treatment of glabellar lines in this study is 10 unit for injection in 5 sites for first 3 volunteer , 20 unit for second 3 volunteer , 40 unit for thirth 3 volunteer and 60 unit for fourth 3 volunteer at 14 days intervals , respectivvely.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Amir Hooshang Ehsani
Street address
Vahdat islami Avenue , Vahdat islami square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Masoondarou Co.
Full name of responsible person
Dr Naser Mohammadpour
Street address
Simindasht industrial City
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Masoondarou Co.
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Research Deputy of Ministry of Health
Full name of responsible person
Dr. Mostafa Ghaneie
Street address
Azadi Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Ministry of Health
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Medicine , Tehran University of Medical Sciences
Full name of responsible person
Dr Amir Hooshang Ehsani
Position
Dermatologist , Associate Professor
Other areas of specialty/work
Street address
School of Medicine , Tehran University of Medical Sciences
City
Tehran
Postal code
1417613151
Phone
+98 21 5563 0668
Fax
Email
ehsanih@sina.tums.ac.ir
Web page address
medicine.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine , Tehran University of Medical Sciences
Full name of responsible person
Dr Amir Hooshang Ehsani
Position
Dermatologist , Associate Professor
Other areas of specialty/work
Street address
School of Medicine , Tehran University of Medical Sciences
City
Tehran
Postal code
1417613151
Phone
+98 21 5563 0668
Fax
Email
ehsanih@sina.tums.ac.ir
Web page address
medicine.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Razi Institute
Full name of responsible person
Dr Naser Mohammadpour
Position
Academic Member of Science
Other areas of specialty/work
Street address
Hessarak , Razi Institute
City
Karaj
Postal code
Phone
+98 26 1457 0042
Fax
Email
Web page address
www.rvsri.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)