Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310863
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Brief Title:
Pivotal Study to Evaluate the Efficacy and Safety of Injection With LASBEAU Strong in Correction of Nasolabial Folds
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Pivotal Study to Evaluate the Efficacy and Safety of Injection With LASBEAU Strong as Compared to Restylane Lyft Lidocaine in Temporary Correction of Nasolabial Folds
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Nonsurgical injectable treatments have become popular for aesthetic purposes In recent years cross-linked hyaluronic acid HA fillers containing lidocaine have been used to correct the nasolabial folds
Aim The aim of this study was to demonstrate the efficacy and safety of a new HA filler LASBEAU Strong 24 mgmL compared with a conventional HA filler Restylane Lyft for the restoration of nasolabial folds
Patientsmethods A total of 72 subjects were enrolled and randomized to receive injections of the new HA filler test group or the conventional HA filler control group on the left or right side of the face The mean value difference in the Wrinkle Severity Rating Scale WSRS scores at week 24 evaluated primary efficacy The WSRS and the Global Aesthetic Improvement Scale GAIS at weeks 8 16 24 and 48 evaluated secondary efficacy Adverse events laboratory tests and a check of vital signs at every visit assessed safety
Aim The aim of this study was to demonstrate the efficacy and safety of a new HA filler LASBEAU Strong 24 mgmL compared with a conventional HA filler Restylane Lyft for the restoration of nasolabial folds
Patientsmethods A total of 72 subjects were enrolled and randomized to receive injections of the new HA filler test group or the conventional HA filler control group on the left or right side of the face The mean value difference in the Wrinkle Severity Rating Scale WSRS scores at week 24 evaluated primary efficacy The WSRS and the Global Aesthetic Improvement Scale GAIS at weeks 8 16 24 and 48 evaluated secondary efficacy Adverse events laboratory tests and a check of vital signs at every visit assessed safety
Detailed Description:
1 Introduction
Hyaluronic acid HA is a type of glycosaminoglycan that has a repeating structure of sodium glucuronate and N-acetylglucosamine unit sugar and that is known as a component of connective tissue such as joint fluid oculovitreous fluid umbilical cord dermis surface layer etc The main function of HA in the extracellular matrix is to stabilize the extracellular structure and form matrix fluid HA has strong hydrophilicity and functions as a natural supply of moisture to the skin contributing to its flexibility and swelling In view of its structural role in tissues protective effect on cell membranes and viscoelasticity HA is ideal as a skin filler Cross-linking is a process in which HA in a liquid state is transformed into a soft solid or gel by chemically combining each chain of HA By slowing down HA metabolism in the human body cross-linked HA can have a long-lasting effect in terms of beauty Among nonsurgical procedures for wrinkle improvement soft tissue augmentation using an injectable filler is one of the most frequently performed cosmetic procedures and is widely applied However there has been a risk of a serious hypersensitivity reaction due to an immune response caused by various substances Among them since HA is a form of polymer with the same structure in all species cross-linked and nonanimal-stabilized HA derivatives have longer-lasting power and less immune response The new HA filler is a biomaterial that contains nonanimal-stabilized HA derived from bacterial fermentation and lidocaine a local anesthetic that reduces pain during the procedure This product is a cross-linked HA gel a biomaterial for tissue repair and was developed to temporarily improve facial wrinkles in the adult face and relieve pain during the procedure The aim of this trial was to demonstrate that the new HA filler consisting of 24 mgmL cross-linked HA containing lidocaine was not inferior to the conventional HA filler which contains the same ingredient for the temporary restoration of nasolabial folds with moderate to severe Wrinkle Severity Rating Scale WSRS scores
2 Materials and methods
21 Trial design
This multicenter randomized double-blind split-face clinical trial was conducted from November 2019 to February 2021 at two investigational sites Asan Medical Center and Nowon Eulji Medical Center in the Republic of Korea This trial protocol was approved by the institutional review board of both institutions and followed the guidelines of the 1975 Declaration of Helsinki All subjects provided written informed consent including a signed photographic consent form before participation in the trial
22 Trial population
From November 2019 to June 2020 among subjects who desired temporary improvement of the nasolabial folds on both sides those who had a WSRS of 3 or 4 points they didnt must have the same score on both sides were enrolled in the trial Subjects aged over 19 years were included in the trial The subjects agreed not to have any other treatment for facial wrinkle correction during the trial period The exclusion criteria were administration of antithrombotic agents excluding low-dose aspirin therapy 100 mg maximum 300 mgday from 2 weeks before to 2 weeks after the injection of the HA fillers administration of vitamin E preparations or NSAID preparations from 1 week before to 1 week after the injection of the HA fillers previous or current bleeding disorders calcium hydroxyapatite CaHA or poly L-lactide PLLA filler treatment within 1 year after the screening date use of topical agents steroids or retinoids only for pharmaceuticals excluding cosmetics on the face within 4 weeks after the screening date or planning to use them during the clinical trial period however for treatment purposes steroid ointments could be used for a short period within 14 consecutive days administration of antiwrinkle therapy acne scar treatment plastic surgery including botulinum toxin injection facial abrasion or skin rejuvenation within the past 24 weeks permanent skin expansion implant such as soft form and silicon on the face skin disorders wound infections on the face and a history of keloid or hypertrophic scar Other exclusion criteria were disagreement to contraception by a medically allowed method for the trial period after the injection of the HA fillers among female subjects who were probably pregnant pregnancy or lactation and clinically significant findings considered inappropriate for this test by the investigator
23 Materials
LASBEAU Strong ExocoBio Inc Seoul Korea an investigational device filled with a colorless transparent liquid filler consisting of 24 mgmL cross-linked HA containing lidocaine was used as a test device in the trial
Restylane Lyft GalDerma a Korea Inc Seoul Korea a filler filled with cross-linked HA containing lidocaine was used as a control device
24 Trial protocol
At the treatment visit week 0 the subjects were randomized to determine into which nasolabial fold the test filler would be injected the control filler was injected into the other nasolabial fold After the HA filler injections the subject was kept under observation for 30 min to check for adverse events AEs The subjects received a subject diary and recorded the occurrence and disappearance of AEs in the subject diary for 2 weeks the subjects returned the subject diary at week 8 The response to the injection of the test and control fillers was documented at weeks 8 16 and 24 The call visit at week 36 performed additional safety assessment At week 48 the subjects completed the trial and evaluated the safety and efficacy of the treatment
25 Treatment procedure
Before the HA filler injections the treatment site was cleansed with disinfecting fluid Subjects were applied to the test filler to one side of the face and the control filler to the contralateral side Following the injection of the two fillers the injection sites were massaged as needed
26 Methods of randomization and blinding
A random-number table was used for randomization The investigator opened the randomization envelopes in the order in which the subjects were registered and injected each HA filler To maintain blindfolding between the subjects and the independent investigators until the end of the trial the subjects and the independent investigators did not know into which side of the nasolabial fold the test filler and the control filler were injected The investigator opened the randomization envelope immediately before the HA filler injections so that the investigator knew the fillers to be injected for each nasolabial fold Before the HA filler injections and at each follow-up visit high-quality digital photographs including the left and right nasolabial folds were taken It was necessary to ensure that the left and right sides were symmetrical from the beginning of the nose lip fold to the tip of the chin centering on the center line of the lips Any information about the subjects was removed from the photographs which were then sent to independent investigators to assess the efficacy of the treatment
27 Efficacy assessment
The primary efficacy measure was mean value differences in the WSRS scores assessed by three independent investigators between baseline and 24 weeks Table 1 WSRS scores were first evaluated by the independent investigators If the WSRS scores were the same among independent investigators they were accepted If the WSRS scores were different they were evaluated by different independent investigators and results of the same values were adopted and interpreted The difference in the mean values of WSRS scores between the test group and the control group was then calculated
The investigators evaluated WSRS and GAIS Global Aesthetic Improvement Scale scores at each follow-up visit as secondary endpoints The independent investigators evaluated the proportion of subjects with an improvement in WSRS scores of one or more points at weeks 24 and 48 The subjects pretreatment photographs served as reference images for assessing improvement Additional visits were performed at weeks 36 call visit and 48 following the HA filler injections At week 36 a call visit was made to check for AEs and concomitant medications at week 48 the subjects visited the hospital took photography of the injection sites and WSRS or GAIS evaluation were performed
28 Safety assessment
Adverse events AEs and serious adverse events SAEs that occurred following the HA filler injections were presented as numbers of subjects percentages and incidences
29 Statistical analyses
The primary efficacy endpoint was the mean value difference in WSRS scores between the test group and the control group as determined by the independent investigators at week 24
The secondary efficacy endpoints included the following 1 The investigators calculated the mean value differences in the WSRS scores between the test group and the control group at weeks 8 16 24 and 48 after the filler injections 2 The investigators calculated the mean value differences in the GAIS scores between the test group and the control group at weeks 8 16 24 and 48 after the filler injections 3 The independent investigators calculated whether the ratio of subjects whose WSRS scores improved by one or more points in the test group and the control group compared with those before the filler injections at weeks 24 and 48 The two-sample t-test and Wilcoxons rank sum test were used for the analyses of endpoints 1 and 2 The chi-square test and Fishers exact test were used for the analysis of endpoints 3 The chi-square test and Fishers exact test were used for the safety analysis The comparisons were subjected to two-tailed tests with a 5 significance level The paired t-test Wilcoxons signed rank test and McNemars test analyzed the laboratory test results vital signs and physical examinations
Hyaluronic acid HA is a type of glycosaminoglycan that has a repeating structure of sodium glucuronate and N-acetylglucosamine unit sugar and that is known as a component of connective tissue such as joint fluid oculovitreous fluid umbilical cord dermis surface layer etc The main function of HA in the extracellular matrix is to stabilize the extracellular structure and form matrix fluid HA has strong hydrophilicity and functions as a natural supply of moisture to the skin contributing to its flexibility and swelling In view of its structural role in tissues protective effect on cell membranes and viscoelasticity HA is ideal as a skin filler Cross-linking is a process in which HA in a liquid state is transformed into a soft solid or gel by chemically combining each chain of HA By slowing down HA metabolism in the human body cross-linked HA can have a long-lasting effect in terms of beauty Among nonsurgical procedures for wrinkle improvement soft tissue augmentation using an injectable filler is one of the most frequently performed cosmetic procedures and is widely applied However there has been a risk of a serious hypersensitivity reaction due to an immune response caused by various substances Among them since HA is a form of polymer with the same structure in all species cross-linked and nonanimal-stabilized HA derivatives have longer-lasting power and less immune response The new HA filler is a biomaterial that contains nonanimal-stabilized HA derived from bacterial fermentation and lidocaine a local anesthetic that reduces pain during the procedure This product is a cross-linked HA gel a biomaterial for tissue repair and was developed to temporarily improve facial wrinkles in the adult face and relieve pain during the procedure The aim of this trial was to demonstrate that the new HA filler consisting of 24 mgmL cross-linked HA containing lidocaine was not inferior to the conventional HA filler which contains the same ingredient for the temporary restoration of nasolabial folds with moderate to severe Wrinkle Severity Rating Scale WSRS scores
2 Materials and methods
21 Trial design
This multicenter randomized double-blind split-face clinical trial was conducted from November 2019 to February 2021 at two investigational sites Asan Medical Center and Nowon Eulji Medical Center in the Republic of Korea This trial protocol was approved by the institutional review board of both institutions and followed the guidelines of the 1975 Declaration of Helsinki All subjects provided written informed consent including a signed photographic consent form before participation in the trial
22 Trial population
From November 2019 to June 2020 among subjects who desired temporary improvement of the nasolabial folds on both sides those who had a WSRS of 3 or 4 points they didnt must have the same score on both sides were enrolled in the trial Subjects aged over 19 years were included in the trial The subjects agreed not to have any other treatment for facial wrinkle correction during the trial period The exclusion criteria were administration of antithrombotic agents excluding low-dose aspirin therapy 100 mg maximum 300 mgday from 2 weeks before to 2 weeks after the injection of the HA fillers administration of vitamin E preparations or NSAID preparations from 1 week before to 1 week after the injection of the HA fillers previous or current bleeding disorders calcium hydroxyapatite CaHA or poly L-lactide PLLA filler treatment within 1 year after the screening date use of topical agents steroids or retinoids only for pharmaceuticals excluding cosmetics on the face within 4 weeks after the screening date or planning to use them during the clinical trial period however for treatment purposes steroid ointments could be used for a short period within 14 consecutive days administration of antiwrinkle therapy acne scar treatment plastic surgery including botulinum toxin injection facial abrasion or skin rejuvenation within the past 24 weeks permanent skin expansion implant such as soft form and silicon on the face skin disorders wound infections on the face and a history of keloid or hypertrophic scar Other exclusion criteria were disagreement to contraception by a medically allowed method for the trial period after the injection of the HA fillers among female subjects who were probably pregnant pregnancy or lactation and clinically significant findings considered inappropriate for this test by the investigator
23 Materials
LASBEAU Strong ExocoBio Inc Seoul Korea an investigational device filled with a colorless transparent liquid filler consisting of 24 mgmL cross-linked HA containing lidocaine was used as a test device in the trial
Restylane Lyft GalDerma a Korea Inc Seoul Korea a filler filled with cross-linked HA containing lidocaine was used as a control device
24 Trial protocol
At the treatment visit week 0 the subjects were randomized to determine into which nasolabial fold the test filler would be injected the control filler was injected into the other nasolabial fold After the HA filler injections the subject was kept under observation for 30 min to check for adverse events AEs The subjects received a subject diary and recorded the occurrence and disappearance of AEs in the subject diary for 2 weeks the subjects returned the subject diary at week 8 The response to the injection of the test and control fillers was documented at weeks 8 16 and 24 The call visit at week 36 performed additional safety assessment At week 48 the subjects completed the trial and evaluated the safety and efficacy of the treatment
25 Treatment procedure
Before the HA filler injections the treatment site was cleansed with disinfecting fluid Subjects were applied to the test filler to one side of the face and the control filler to the contralateral side Following the injection of the two fillers the injection sites were massaged as needed
26 Methods of randomization and blinding
A random-number table was used for randomization The investigator opened the randomization envelopes in the order in which the subjects were registered and injected each HA filler To maintain blindfolding between the subjects and the independent investigators until the end of the trial the subjects and the independent investigators did not know into which side of the nasolabial fold the test filler and the control filler were injected The investigator opened the randomization envelope immediately before the HA filler injections so that the investigator knew the fillers to be injected for each nasolabial fold Before the HA filler injections and at each follow-up visit high-quality digital photographs including the left and right nasolabial folds were taken It was necessary to ensure that the left and right sides were symmetrical from the beginning of the nose lip fold to the tip of the chin centering on the center line of the lips Any information about the subjects was removed from the photographs which were then sent to independent investigators to assess the efficacy of the treatment
27 Efficacy assessment
The primary efficacy measure was mean value differences in the WSRS scores assessed by three independent investigators between baseline and 24 weeks Table 1 WSRS scores were first evaluated by the independent investigators If the WSRS scores were the same among independent investigators they were accepted If the WSRS scores were different they were evaluated by different independent investigators and results of the same values were adopted and interpreted The difference in the mean values of WSRS scores between the test group and the control group was then calculated
The investigators evaluated WSRS and GAIS Global Aesthetic Improvement Scale scores at each follow-up visit as secondary endpoints The independent investigators evaluated the proportion of subjects with an improvement in WSRS scores of one or more points at weeks 24 and 48 The subjects pretreatment photographs served as reference images for assessing improvement Additional visits were performed at weeks 36 call visit and 48 following the HA filler injections At week 36 a call visit was made to check for AEs and concomitant medications at week 48 the subjects visited the hospital took photography of the injection sites and WSRS or GAIS evaluation were performed
28 Safety assessment
Adverse events AEs and serious adverse events SAEs that occurred following the HA filler injections were presented as numbers of subjects percentages and incidences
29 Statistical analyses
The primary efficacy endpoint was the mean value difference in WSRS scores between the test group and the control group as determined by the independent investigators at week 24
The secondary efficacy endpoints included the following 1 The investigators calculated the mean value differences in the WSRS scores between the test group and the control group at weeks 8 16 24 and 48 after the filler injections 2 The investigators calculated the mean value differences in the GAIS scores between the test group and the control group at weeks 8 16 24 and 48 after the filler injections 3 The independent investigators calculated whether the ratio of subjects whose WSRS scores improved by one or more points in the test group and the control group compared with those before the filler injections at weeks 24 and 48 The two-sample t-test and Wilcoxons rank sum test were used for the analyses of endpoints 1 and 2 The chi-square test and Fishers exact test were used for the analysis of endpoints 3 The chi-square test and Fishers exact test were used for the safety analysis The comparisons were subjected to two-tailed tests with a 5 significance level The paired t-test Wilcoxons signed rank test and McNemars test analyzed the laboratory test results vital signs and physical examinations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None