Evaluation of efficacy and safety of "MediVim" HA dermal fillers in correction of moderate-to-severe Nasolabial folds
Design
An interventional, randomized, non-placebo, non-blinded, treatment-intent, single-study, phase 2 clinical trial on 33 patients.
Settings and conduct
The study will be conducted in the dermatology clinic of Razi Hospital. Before the intervention, face photography will be taken from participants using a Visioface camera، and the intensity of the wrinkles is scored based on the 5-point photonumeric Allergan scale from 0 (no wrinkles) to 4 (very deep wrinkles). For each person with a score of 3 & 4, one injection with 1 ml of Medivim Filler (produced by Nik Sina Eksir) intradermally in the NLF will be done. The assessments will be repeated immediately after the intervention, 2 weeks and 3 months later. Subjects’ satisfaction and adverse effect will be recorded in each follow-up visit.
Participants/Inclusion and exclusion criteria
30-65 years old women and men, with moderate to severe nasolabial folds, without any cosmetic facial procedures during the last 3 months, without any allergy to lidocaine, hyaluronic acid and no autoimmune or immune deficiency diseases. No pregnant and breastfeeding
Intervention groups
Medivim Intradermal filler injection in the form of sterilized pre-filled syringes with a volume of 1 ml for 33 patients who have moderate to severe nasolabial folds. Medivim Filler contains: Hyaluronic Acid gel 24 mg; Phosphate buffer (pH 7); Lidocaine hydrochloride, 0.3%
Main outcome variables
Severity of nasolabial folds based on the 5-point photonumeric Allergan scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220723055530N3
Registration date:2024-01-06, 1402/10/16
Registration timing:prospective
Last update:2024-01-06, 1402/10/16
Update count:0
Registration date
2024-01-06, 1402/10/16
Registrant information
Name
Amirhooshang Ehsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 0223
Email address
ehsanih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-07, 1402/10/17
Expected recruitment end date
2024-01-14, 1402/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of "MediVim" HA dermal fillers in correction of moderate-to-severe Nasolabial folds
Public title
Assessment of the Results of Medivim Filler Injections to Correction Nasolabial Folds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
30 -65 Years old men and women with moderate to severe nasolabial folds
Signing the informed consent form
Exclusion criteria:
History of a cosmetic procedure in the lower 2/3 of the face during the last three months
Previous allergy to Hyaluronic Acid or Lidocaine
Presence of inflammation, active infection, unhealed old wound, and skin lesions in the NLF region
People prone to hypertrophic scar formation
History of autoimmune or immune deficiency diseases
Pregnancy or breastfeeding
Age
From 30 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
33
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
Ethics committee of 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
2023-12-26, 1402/10/05
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.525
Health conditions studied
1
Description of health condition studied
Skin aging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of nasolabial folds
Timepoint
Before intervention, immediately after that, 2 weeks, and 3 months later
Method of measurement
Five-point photonumeric Allergan scale
Secondary outcomes
1
Description
Area, depth, and volume of nasolabial folds
Timepoint
Before the intervention, immediately after that, 2 weeks, and 3 months later
Method of measurement
Visioface camera
Intervention groups
1
Description
Intervention group: Injection of Medivim Intradermal filler in the nasolabial folds, the products are in the 1 ml pre-filled sterilized syringe containing:Medivim:Hyaluronic Acid gel 24 mg; Lidocaine hydrochloride, 0.3% ; Phosphate buffer (pH 7), 1 ml
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic of Razi Hospital
Full name of responsible person
Amirhooshang Ehsani
Street address
Razi Hospital, Vahdateeslami St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0705
Email
ehsanih@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nik Sina Eksir
Full name of responsible person
Seyed Mohammad Hosseini
Street address
unit 20, fifth floor, No. 1, Laplace Building, Mosfa (Yas) dead end corner, Safarzadeh St. (Fath), Kaveh Blvd (south), Sadr Highway (west-east route)
City
Tehran
Province
Tehran
Postal code
١٩٣٩٧٥٣١٤٥
Phone
+98 21 2261 1726
Email
info@ncexir.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nik Sina Eksir
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
Maryam Nasimi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Vahdat Eslami Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0705
Email
nsm.maryam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhooshang Ehsani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Vahdat Eslami Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0705
Email
ehsanih@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Nasimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Vahdat Eslami Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0705
Email
nsm.maryam@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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