Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604832
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Effects of Microtox on Facial Skin Quality Fine Wrinkles and Texture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of PrabotulinumtoxinA-xvfs on Facial Skin Quality Fine Wrinkles and Texture
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this split-face clinical trial is to test the efficacy of microtox in improving facial skin quality fine wrinkles and texture Participants will
be randomly assigned to Group A which will receive 20 units of neuromodulator on the left side of the forehead and a placebo saline treatment on the right side or Group B which will receive 20 units of neuromodulator on the left side of the forehead and 20 units of a different neuromodulator brand on the right side as a comparator
have one treatment session at week 0 and two live assessment visits at weeks 2 and 12
have their pictures taken at each visit to track progress
be randomly assigned to Group A which will receive 20 units of neuromodulator on the left side of the forehead and a placebo saline treatment on the right side or Group B which will receive 20 units of neuromodulator on the left side of the forehead and 20 units of a different neuromodulator brand on the right side as a comparator
have one treatment session at week 0 and two live assessment visits at weeks 2 and 12
have their pictures taken at each visit to track progress
Detailed Description:
Twenty 20 subjects will be enrolled in the study The subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12 Office visits will last approximately 2 hours All subjects will have their photographs taken at the beginning of each visit to track progress Photographs will be taken of the forehead in a relaxed state with eyebrows furrowed and with eyebrows raised All pictures will be taken via the Quantificare LifeViz Micro and will be stored via a HIPAA-compliant server
Subjects will be randomly assigned to one of two groups Group A will receive 10 units of prabotulinumtoxinA-xvfs delivered intramuscularly to the corrugator supercilii on the left of the glabellar lines 10 units of prabotulinumtoxinA-xvfs delivered intradermally 1 mm depth to the left side of the forehead region and a placebo saline treatment on the right side of the glabellar lines and forehead region Group B will receive 10 units of prabotulinumtoxinA-xvfs delivered intramuscularly to the corrugator supercilii on the left of the glabellar lines 10 units of prabotulinumtoxinA-xvfs delivered intradermally 1 mm depth to the left side of the forehead region and 20 units of incobotulinumtoxinA on the right side intramuscularly in the glabellar region and intradermally in the forehead region
100 units of botulinum toxin A will be reconstituted with 5 mL of bacteriostatic saline After subjects have their picture taken topical LidocaineTetracaine 237 ointment cream will be applied to the treatment sites After 15 minutes of numbing the topical anesthetic will be cleaned off with alcohol Subjects will be asked to repeatedly furrow and raise their eyebrows to let the treating physician assess the muscle of interest With the subject in a semi-reclined position the treating physician will inject microboluses using a standard 30 gauge 05 needle
At each visit the treating physician will rate each subject according to the Scientific Assessment Scale of Skin Quality SASSQ The Global Aesthetic Improvement Scale GAIS will be used by the treating physician and subjects to rate aesthetic improvement at each visit after baseline Subjects will also rate their overall aesthetic improvement and treatment satisfaction at each visit after baseline according to a 5-point scale 1 Extremely dissatisfied 2 Dissatisfied 3 Slightly satisfied 4 Satisfied 5 Extremely satisfied Before and after photos of treated patients will be independently evaluated by the blinded secondary evaluator using the SASSQ scale at each time interval of photos taken
Subjects will be randomly assigned to one of two groups Group A will receive 10 units of prabotulinumtoxinA-xvfs delivered intramuscularly to the corrugator supercilii on the left of the glabellar lines 10 units of prabotulinumtoxinA-xvfs delivered intradermally 1 mm depth to the left side of the forehead region and a placebo saline treatment on the right side of the glabellar lines and forehead region Group B will receive 10 units of prabotulinumtoxinA-xvfs delivered intramuscularly to the corrugator supercilii on the left of the glabellar lines 10 units of prabotulinumtoxinA-xvfs delivered intradermally 1 mm depth to the left side of the forehead region and 20 units of incobotulinumtoxinA on the right side intramuscularly in the glabellar region and intradermally in the forehead region
100 units of botulinum toxin A will be reconstituted with 5 mL of bacteriostatic saline After subjects have their picture taken topical LidocaineTetracaine 237 ointment cream will be applied to the treatment sites After 15 minutes of numbing the topical anesthetic will be cleaned off with alcohol Subjects will be asked to repeatedly furrow and raise their eyebrows to let the treating physician assess the muscle of interest With the subject in a semi-reclined position the treating physician will inject microboluses using a standard 30 gauge 05 needle
At each visit the treating physician will rate each subject according to the Scientific Assessment Scale of Skin Quality SASSQ The Global Aesthetic Improvement Scale GAIS will be used by the treating physician and subjects to rate aesthetic improvement at each visit after baseline Subjects will also rate their overall aesthetic improvement and treatment satisfaction at each visit after baseline according to a 5-point scale 1 Extremely dissatisfied 2 Dissatisfied 3 Slightly satisfied 4 Satisfied 5 Extremely satisfied Before and after photos of treated patients will be independently evaluated by the blinded secondary evaluator using the SASSQ scale at each time interval of photos taken
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None