A single-arm, before- after clinical study to evaluate the safety and efficacy of Inshape X® intradermal filler containing 150mg poly-L-lactic acid (NanoDaru Pajuhan Pardis) for correction of moderate to severe nasolabial folds
Evaluate the safety and efficacy of Inshape X® intradermal filler containing 150mg poly-L-lactic acid (NanoDaru Pajuhan Pardis) 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 Inshape X® intradermal filler made by NanoDaru Pajuhan Pardis Company will be performed on each nasolabial fold. The assessment will be repeated one, 3, 6 and12 months after intervention. 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. Signing the informed consent form and agree to a 6-month follow-up.
Exclusion criteria:
History of type 1 allergic reactions or anaphylaxis reactions, Previous allergy to filler and lidocaine ingredients, History of hypertrophic and colloid scars or bleeding disorders in the nasolabial region
Intervention groups
receiving a subcutaneous dose of Inshape-x-scalp suspension (poly-L-lactic acid of Pardis Nano Darou Pazhouhan Pharmaceutical Company) containing 150 mg, using one of the linear threading, Fanning, Serial puncture, and Cross hatch techniques, according to the researcher's opinion.
Main outcome variables
Severity of nasolabial folds according to Allergan grading
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N26
Registration date:2023-11-12, 1402/08/21
Registration timing:prospective
Last update:2023-11-12, 1402/08/21
Update count:0
Registration date
2023-11-12, 1402/08/21
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
2023-11-22, 1402/09/01
Expected recruitment end date
2024-02-20, 1402/12/01
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 Inshape X® intradermal filler containing 150mg poly-L-lactic acid (NanoDaru Pajuhan Pardis) for correction of moderate to severe nasolabial folds
Public title
evaluate the safety and efficacy of Inshape X® intradermal filler
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 reactions
Previous allergy to filler and lidocaine ingredients
History of hypertrophic and colloid scars or bleeding disorders in the nasolabial region
Active inflammatory processes, infection, lesion (cancerous/noncancerous) in the nasolabial region
Pregnancy and 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
2023-11-10, 1402/08/19
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.097
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 4 weeks later
Method of measurement
5 scale Allergan photo numeric grading
Secondary outcomes
1
Description
Severity of nasolabial folds
Timepoint
Before intervention, 3, 6 and 12 months later
Method of measurement
5 scale Allergan photo numeric grading
2
Description
Severity of nasolabial folds
Timepoint
Before intervention, 1, 3, 6 and 12 months later
Method of measurement
Based on GAIS scale compared to base mode
3
Description
Depth, area and volume of nasolabial fold
Timepoint
Before intervention, 1, 6 and 12 months later
Method of measurement
Visioface camera
Intervention groups
1
Description
Intervention group: receiving a subcutaneous dose of inshape-x-scalp suspension (poly-L-lactic acid of Pardis Nano Darou Pazhouhan Pharmaceutical Company) containing 150 mg, using one of the linear threading, Fanning, Serial puncture, and Cross hatch techniques, according to the researcher's opinion. Preparation of each vial is done using 8ml sterile water. In order to pain reduction, 1 ml of lidocaine 2% will be added to the prepared suspension before injection and the final suspension volume will be 9 ml.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research and Training in Skin Diseases and Leprosy