A phase IV single-arm clinical trial to evaluate the safety and satisfaction of AbobotulinumtoxinA (Lucentra®) in the treatment of upper facial wrinkles
The objectives of this study are to assess safety, and subject satisfaction of Abobotulinum toxin A (Espad Pharmed)
Design
The study is designed as phase IV, single-armed, prospective study
Settings and conduct
A phase IV single-arm clinical trial to evaluate the safety and satisfaction of AbobotulinumtoxinA (Lucentra®) in the treatment of upper facial wrinkles this study will be performed during 120 days for each participants.
Participants/Inclusion and exclusion criteria
1. Male or female ≥18 to ≤65 years of age
2. Willingness for signing and having signed the informed consent form
3. Indication of treatment with botulinum toxin type A in the upper face
Exclusion criteria:
1. Previous treatment with botulinum toxin type A, fillers, skin abrasions, or photo rejuvenation in the upper face 4 months prior to study
2. Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data
3. Pregnancy or breast-feeding
Intervention groups
All the participants received a single administration of Abobotulinumtoxin A (dose and injection sites per standard practice). Touch-up at Day 14 allowed at the investigator's discretion.
Main outcome variables
Safety
participant satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150303021315N39
Registration date:2025-10-30, 1404/08/08
Registration timing:prospective
Last update:2025-10-30, 1404/08/08
Update count:0
Registration date
2025-10-30, 1404/08/08
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-01, 1404/08/10
Expected recruitment end date
2026-03-30, 1405/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A phase IV single-arm clinical trial to evaluate the safety and satisfaction of AbobotulinumtoxinA (Lucentra®) in the treatment of upper facial wrinkles
Public title
Phase IV study of Lucentra® (Espad pharmed)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female ≥18 to ≤65 years of age
Willingness for signing and having signed the informed consent form
Indication of treatment with botulinum toxin type A in the upper face
Exclusion criteria:
Previous treatment with botulinum toxin type A, fillers, skin abrasions, or photo rejuvenation in the upper face 4 months prior to study
Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data
3. Pregnancy or breast-feeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
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
Ethics committee of Tehran University of Medical Sciences
Street address
Central Building of TUMS, Ghods Ave,Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2025-10-14, 1404/07/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1404.444
Health conditions studied
1
Description of health condition studied
Upper face wrinkles
ICD-10 code
L98.8
ICD-10 code description
Other specified disorders of the skin and subcutaneous tissue
Primary outcomes
1
Description
Evaluation of AbobotulinumtoxinA safety
Timepoint
during all scheduled visits
Method of measurement
Assessment of the adverse events
Secondary outcomes
1
Description
Subject satisfaction
Timepoint
Day 14, Day 120
Method of measurement
Likert satisfaction scale
2
Description
The need for touch-up injections
Timepoint
Day 14
Method of measurement
Physcian assessment
3
Description
Total injected dose
Timepoint
Day 14
Method of measurement
Calculating total injected dose
4
Description
The onset of action
Timepoint
Day 14
Method of measurement
Subject self assessment (SSA)
Intervention groups
1
Description
Intervention group: Injection of Botulinum Toxin Type A (Lucentra®) manufactured by Espad Pharmed Co, supplied in 300- and 500-unit vials.The intervention consists of a single-session injection into the upper facial area.(The dose and injection sites are determined based on the participant’s needs and the physician’s routine practice.)Touch-up injection on day 14 is permitted at the investigator’s discretion.
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 Eslami Street, Vahdat Eslami sq
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 912 343 6493
Email
ehsanih@tums.ir
2
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Fateme Saberi
Street address
Vahdat Eslami Street, Vahdat Eslami sq
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 912 610 2904
Email
Drsabri@gmail.com
3
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Mahshid sadat Ansari
Street address
Vahdat Eslami Street, Vahdat Eslami sq
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 913 397 8000
Email
Mahshid.ansarii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Espad Pharmed
Full name of responsible person
Dr. Hooshiar Gholami
Street address
No. 56, Azimi Street, Nafisi Street, Ekbatan
City
Tehran
Province
Tehran
Postal code
1393833166
Phone
+98 21 4463 1124
Email
info@espadpharmedco.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?