A single-arm, before- after clinical study to evaluate the safety and efficacy of Intella dermal filler (produced by Espad Pharmed Darou Co.) for correction of moderate to severe nasolabial folds
Evaluation of safety and efficacy of Intella dermal filler (produced by Espad Pharmed Darou Co.) for correction of moderate to severe nasolabial folds
Design
Single group, phase 2, before -after clinical study. sample size is 30. The study is not randomized
Settings and conduct
The study will be conducted in Center for research and training in skin diseases and leprosy. Before intervention face photography will be taken from participants using digital camera and Visioface camera for determination the severity of nasolabial folds, according to Allergan scale. Skin ultrasound also will perform on nasolabial folds. One intradermal injection with Intella will be performed on each nasolabial fold. The assessment will be repeated right after intervention and 2, 4, 12 and 24 weeks later. Subjects’ satisfaction and adverse effect will be recorded in each follow up visit
Participants/Inclusion and exclusion criteria
Inclusion criteria:
18-65 year old men and women, Moderate to severe nasolabial folds based on Allergan criteria, The opportunity to accompany the visit programs and study process.
Exclusion criteria:
History of type 1 allergic reactions or anaphylaxis reaction, Pregnancy or lactation
Intervention groups
One injection with 1-2 ml Intella brand gel in each nasolabial folds. Intella is a pyrogen-free, viscous, opaque, injectable, semi-solid, latex-free and biodegradable dermal filler gel.
Main outcome variables
Severity of nasolabial folds according to Allergan grading
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N27
Registration date:2024-01-24, 1402/11/04
Registration timing:registered_while_recruiting
Last update:2024-01-24, 1402/11/04
Update count:0
Registration date
2024-01-24, 1402/11/04
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A single-arm, before- after clinical study to evaluate the safety and efficacy of Intella dermal filler (produced by Espad Pharmed Darou Co.) for correction of moderate to severe nasolabial folds
Public title
Clinical study to evaluate the safety and efficacy of Intella dermal filler for correction of nasolabial folds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 year old men and women
Moderate to severe nasolabial folds based on Allergan criteria
The opportunity to accompany the visit programs and study process.
Signing the informed consent form and agree to a 6-month follow-up
Exclusion criteria:
History of type 1 allergic reactions or anaphylaxis reaction
Previous hyaluronic acid-based dermal filler injected within the last 12 months prior to enrollment.
History of hypertrophic and keloid scars or bleeding disorders in the nasolabial region
Active inflammatory processes, infection, lesions (cancerous/non-cancerous) in the nasolabial region
History of autoimmune diseases/immune deficiency or use of immunosuppressive medicines during the 6 months before entering the study or during the study
Pregnancy or lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor, The Institute of Pharmaceutical Sciences, Faculty of Pharmacy, 16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2024-01-02, 1402/10/12
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.145
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 and right after intervention and 2, 4, 12 and 24 weeks later
Method of measurement
5 scale Allergan photo numeric grading
Secondary outcomes
1
Description
Number of people with at least one grade of reduction in the severity of both nasolabial folds
Timepoint
Before intervention and 3 and 6 months later
Method of measurement
scale Allergan photo numeric grading
2
Description
Depth, area and volume of nasolabial fold
Timepoint
Before intervention ,1 ,3 and 6 months later
Method of measurement
Visioface camera
3
Description
Thickness and density of dermis
Timepoint
Before intervention ,1 and 6 months later
Method of measurement
Skin ultrasound
Intervention groups
1
Description
Intervention group: One injection with 1-2 ml Intella brand gel produced by Espad Pharmed company in each nasolabial folds. Intella is a pyrogen-free, viscous, opaque, injectable, semi-solid, latex-free and biodegradable dermal filler gel. Ingredients: calcium hydroxyapatite microspheres with a diameter of 25-45 microns (55.7%), cross-linked sodium hyaluronate gel (20 mg per ml), lidocaine hydrochloride (3 mg per ml), phosphate buffer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research and Training in Skin Diseases and Leprosy