Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133153
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-11-03
Brief Title:
THIODERM ELATE for Volume Augmentation in Lips
Sponsor:
Croma-Pharma GmbH
Organization:
Croma-Pharma GmbH
Study Overview
Official Title:
A Pivotal Randomized Subject- and Evaluator-blinded Controlled Non-inferiority Multicenter Parallel Group Comparison Study to Evaluate Effectiveness and Safety of THIODERM ELATE for Lip Augmentation in Order to Correct Lip Volume Deficit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
TIVOLI
Brief Summary:
A pivotal randomized subject- and evaluator-blinded controlled non-inferiority multicenter parallel group comparison study to evaluate effectiveness and safety of THIODERM ELATE for lip augmentation in order to correct lip volume deficit
Detailed Description:
The clinical investigation will comprise randomization to one of two treatment groups
Test device THIODERM ELATE
Comparator device Juvéderm ULTRA 3 The Screening visit Visit 1 will be performed within 2 weeks prior to randomization and will entail informed consent and screening assessments During this visit the treating investigator will determine eligibility of subjects based on study inclusion and exclusion criteria - except for Baseline severity of lip volume deficit that will be determined at Screening visit Visit 1 by the blinded evaluator at the site using the 5-point LFS
In addition the subjects face will be photographed to document baseline condition for further assessments
At Baseline visit Visit 2 Day 0 eligible subjects will be randomized in a 21 ratio and undergo lip augmentation treatment of both upper and lower lip with either THIODERM ELATE or Juvéderm ULTRA 3 baseline treatment
If an optimal aesthetic correction has not been achieved after the baseline treatment as evaluated by the treating investigator a touch-up treatment may be performed at Week 4 Visit 3 using the same device as initially applied at Visit 2
As of Week 36 Visit 7 SV1 after last treatment either baseline or touch-up treatment of the initial treatment phase subjects of both treatment groups test device and comparator device may qualify for a repeat-treatment which will be done with THIODERM ELATE only Further Screening visits for repeat-treatment may be conducted after Visit 7 SV1 if the subject does not qualify at Visit 7SV1 already for repeat-treatment
Screening phase for repeat-treatment will be up to 20 weeks after Visit 7 SV1 with Visit SV2 12 weeks after Visit 7 SV1 Visit SV3 16 weeks after Visit 7 SV1 and Visit SV4 20 weeks after Visit 7 SV1
As soon as the subject is eligible in LFS score as assessed by the blinded evaluator at the site a full eligibility assessment for repeat-treatment will be done by the treating investigator Subjects do not have to return to their baseline severity of lip volume deficit to be eligible and receive a repeat-treatment but the present condition of lip volume deficit must meet the initial inclusion criterion very thin lips or thin lips or moderately thick lips in both lips The blinded evaluating investigator at the site decides if a subject is eligible for the repeat-treatment regarding LFS
Visit SV4 20 weeks after Visit 7 SV1 will be the end of investigation visit for subjects who do not qualify for repeat-treatment In case an inclusion criterion is not met an exclusion criterion is met for repeat-treatment and further follow up in screening is not useful because the subject will apparently not qualify for repeat-treatment the respective Screening Visit SV1 SV2 SV3 or SV4 will be the end of investigation visit for the respective subject
Subjects who are eligible and undergo repeat-treatment at Visit RT1 will enter the repeat-treatment follow-up phase Subjects may receive a touch-up treatment after 4 weeks Visit RT2 based on the treating investigators judgement The follow-up period will be 24 weeks after the last treatment initial repeat treatment or touch-up treatment respectively
Follow-up visits on-site will occur at
Initial treatment phase Week 4 and Week 8 after baseline treatment and 12 24 and 36 weeks after last treatment ie baseline or touch-up treatment respectively Visits 3 to 7 SV1
Screening phase for repeat-treatment Week 12 16 and 20 after Visit 7 SV1 - Visits SV2 to SV4
Repeat-treatment phase Week 4 8 12 and 24 after initial repeat-treatment Visits RT2 to RT5 regardless of whether a touch-up treatment has been performed or not Visit RT2 to RT5 In addition to the on-site follow-up visits 24-48 hours after each treatment the subjects will be contacted by phone for safety checkup If applicable the incidence severity seriousness and type of adverse events resulting from device injection will be determined and closely followed up until resolution
Lip volume deficit will be evaluated live assessment by the blinded evaluator at the site using the 5-point LFS during follow-up visits of the initial and repeat-treatment phase In addition volume change measurements will be done on 3D photographs
Subjects pain perception during treatment and recovery from treatment will be evaluated by means of a numerical pain rating scale NPRS immediately after and 15 and 30 minutes after last injection of each treatment session
Global aesthetic improvement will be evaluated by reviewing and comparing current photographs relative to photographs taken at Screening visit Both - the blinded evaluator at the site and the subject - will assess the global aesthetic improvement using the modified GAIS at each on-site visit after subject was fully treated baseline and touch-up treatment as applicable during the initial treatment phase
Subjects satisfaction with the outcome of the treatment will be assessed with the FACE-QTM questionnaires Satisfaction with Outcome and Satisfaction with Lips at each on-site visit after subject was fully treated baseline repeat-treatment and touch-up treatment as applicable during the initial and repeat-treatment phase respectively Subjects Satisfaction with Lips will also be assessed at Visit 2 Baseline visit and Visit RT1
The safety will be evaluated based on occurrence of adverse events which will be collected at each visit on-site and telephone visits throughout the clinical investigation beginning after signature of the ICF until the last visit
To identify potential adverse events post-administration a safety evaluation after 30 minutes needs to take place
A subject diary will be used to record injection site reactions and symptoms of interest ie vaso-occlusive events such as changes in vision or symptoms of stroke over the first four weeks 28 days after each treatment ie either 4 weeks after baseline and repeat-treatment or in total 8 weeks in case of touch-up treatment
To evaluate any potential vision changes visual examinations including Snellen visual acuity confrontational visual fields and ocular motility will be additionally performed at treatment visits prior to- and 30 min after any treatment and at all follow-up visits of the initial and repeat-treatment phase A basic neurological examination FAST will be performed for all subjects who show signs of ophthalmic complications due to filler injection
Abnormal clinically significant changes in visual examination or experience of neurological symptoms indicative of a vaso-occlusive event after any treatment will lead to withdrawal of the subject from further treatments in case an eye specialist or neurologist confirms that the result is related to a vascular injection of the dermal filler The subjects may remain in the study for at least safety assessments during the scheduled study visits In such case stopping the entire investigation will be reviewed
Test device THIODERM ELATE
Comparator device Juvéderm ULTRA 3 The Screening visit Visit 1 will be performed within 2 weeks prior to randomization and will entail informed consent and screening assessments During this visit the treating investigator will determine eligibility of subjects based on study inclusion and exclusion criteria - except for Baseline severity of lip volume deficit that will be determined at Screening visit Visit 1 by the blinded evaluator at the site using the 5-point LFS
In addition the subjects face will be photographed to document baseline condition for further assessments
At Baseline visit Visit 2 Day 0 eligible subjects will be randomized in a 21 ratio and undergo lip augmentation treatment of both upper and lower lip with either THIODERM ELATE or Juvéderm ULTRA 3 baseline treatment
If an optimal aesthetic correction has not been achieved after the baseline treatment as evaluated by the treating investigator a touch-up treatment may be performed at Week 4 Visit 3 using the same device as initially applied at Visit 2
As of Week 36 Visit 7 SV1 after last treatment either baseline or touch-up treatment of the initial treatment phase subjects of both treatment groups test device and comparator device may qualify for a repeat-treatment which will be done with THIODERM ELATE only Further Screening visits for repeat-treatment may be conducted after Visit 7 SV1 if the subject does not qualify at Visit 7SV1 already for repeat-treatment
Screening phase for repeat-treatment will be up to 20 weeks after Visit 7 SV1 with Visit SV2 12 weeks after Visit 7 SV1 Visit SV3 16 weeks after Visit 7 SV1 and Visit SV4 20 weeks after Visit 7 SV1
As soon as the subject is eligible in LFS score as assessed by the blinded evaluator at the site a full eligibility assessment for repeat-treatment will be done by the treating investigator Subjects do not have to return to their baseline severity of lip volume deficit to be eligible and receive a repeat-treatment but the present condition of lip volume deficit must meet the initial inclusion criterion very thin lips or thin lips or moderately thick lips in both lips The blinded evaluating investigator at the site decides if a subject is eligible for the repeat-treatment regarding LFS
Visit SV4 20 weeks after Visit 7 SV1 will be the end of investigation visit for subjects who do not qualify for repeat-treatment In case an inclusion criterion is not met an exclusion criterion is met for repeat-treatment and further follow up in screening is not useful because the subject will apparently not qualify for repeat-treatment the respective Screening Visit SV1 SV2 SV3 or SV4 will be the end of investigation visit for the respective subject
Subjects who are eligible and undergo repeat-treatment at Visit RT1 will enter the repeat-treatment follow-up phase Subjects may receive a touch-up treatment after 4 weeks Visit RT2 based on the treating investigators judgement The follow-up period will be 24 weeks after the last treatment initial repeat treatment or touch-up treatment respectively
Follow-up visits on-site will occur at
Initial treatment phase Week 4 and Week 8 after baseline treatment and 12 24 and 36 weeks after last treatment ie baseline or touch-up treatment respectively Visits 3 to 7 SV1
Screening phase for repeat-treatment Week 12 16 and 20 after Visit 7 SV1 - Visits SV2 to SV4
Repeat-treatment phase Week 4 8 12 and 24 after initial repeat-treatment Visits RT2 to RT5 regardless of whether a touch-up treatment has been performed or not Visit RT2 to RT5 In addition to the on-site follow-up visits 24-48 hours after each treatment the subjects will be contacted by phone for safety checkup If applicable the incidence severity seriousness and type of adverse events resulting from device injection will be determined and closely followed up until resolution
Lip volume deficit will be evaluated live assessment by the blinded evaluator at the site using the 5-point LFS during follow-up visits of the initial and repeat-treatment phase In addition volume change measurements will be done on 3D photographs
Subjects pain perception during treatment and recovery from treatment will be evaluated by means of a numerical pain rating scale NPRS immediately after and 15 and 30 minutes after last injection of each treatment session
Global aesthetic improvement will be evaluated by reviewing and comparing current photographs relative to photographs taken at Screening visit Both - the blinded evaluator at the site and the subject - will assess the global aesthetic improvement using the modified GAIS at each on-site visit after subject was fully treated baseline and touch-up treatment as applicable during the initial treatment phase
Subjects satisfaction with the outcome of the treatment will be assessed with the FACE-QTM questionnaires Satisfaction with Outcome and Satisfaction with Lips at each on-site visit after subject was fully treated baseline repeat-treatment and touch-up treatment as applicable during the initial and repeat-treatment phase respectively Subjects Satisfaction with Lips will also be assessed at Visit 2 Baseline visit and Visit RT1
The safety will be evaluated based on occurrence of adverse events which will be collected at each visit on-site and telephone visits throughout the clinical investigation beginning after signature of the ICF until the last visit
To identify potential adverse events post-administration a safety evaluation after 30 minutes needs to take place
A subject diary will be used to record injection site reactions and symptoms of interest ie vaso-occlusive events such as changes in vision or symptoms of stroke over the first four weeks 28 days after each treatment ie either 4 weeks after baseline and repeat-treatment or in total 8 weeks in case of touch-up treatment
To evaluate any potential vision changes visual examinations including Snellen visual acuity confrontational visual fields and ocular motility will be additionally performed at treatment visits prior to- and 30 min after any treatment and at all follow-up visits of the initial and repeat-treatment phase A basic neurological examination FAST will be performed for all subjects who show signs of ophthalmic complications due to filler injection
Abnormal clinically significant changes in visual examination or experience of neurological symptoms indicative of a vaso-occlusive event after any treatment will lead to withdrawal of the subject from further treatments in case an eye specialist or neurologist confirms that the result is related to a vascular injection of the dermal filler The subjects may remain in the study for at least safety assessments during the scheduled study visits In such case stopping the entire investigation will be reviewed
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?:
False
Is an FDA AA801 Violation?:
None