Clinical trial NCT06604832: Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture
Official title: Effects of PrabotulinumtoxinA-xvfs on Facial Skin Quality, Fine Wrinkles, and Texture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Skin Aging
Skin Wrinkling
Keywords: Microtox
Minimally invasive
Skin quality
Skin texture
Fine wrinkling
Botulinum toxin
PrabotulinumtoxinA-xvfs
Glabellar lines
Lead sponsor: K. Kay Durairaj, MD, FACS, A Medical Corporation
Sponsor class: OTHER
Collaborators: name: Evolus, Inc.
First posted: 2024-09-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 Lidocaine/Tetracaine 23%/7% 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 0.5" 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.

Eligibility criteria: Inclusion Criteria:

* Biological females, 18-65 years old, of any race and ethnic background
* Individuals with mild to moderate facial wrinkles
* All skin types (Fitzpatrick I-VI)
* Willingness to participate and provide written informed consent
* Ability to follow study instructions and likely to complete all required visits

Exclusion Criteria:

* Females who are pregnant, breastfeeding, chronically using nonsteroidal anti-inflammatory drugs, have autoimmune conditions or have a known allergy to the study medications.
* Previous cosmetic procedures near the forehead within the last 6 months or botulinum toxin treatments within the last 4 months
* Known neuromuscular disorders or a hypersensitivity to botulinum toxin
* Significant dermatological conditions affecting the face
* Use of medications affecting neuromuscular function or skin healing within 2 weeks prior to the beginning of study
* Subject has a condition or is in a situation which, in the opinion of the Investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.

Primary outcomes:
measure: Scientific Assessment Scale of Skin Quality (SASSQ) Rating
timeFrame: Up to 12 weeks
measure: Global Aesthetic Improvement Scale (GAIS) Rating
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Scientific Assessment Scale of Skin Quality (SASSQ) Rating
timeFrame: Up to 2 weeks
measure: Global Aesthetic Improvement Scale (GAIS) Rating
timeFrame: Up to 2 weeks
measure: Global Aesthetic Improvement Scale (GAIS) Rating
timeFrame: Up to 12 weeks
measure: Scientific Assessment Scale of Skin Quality (SASSQ) Rating
timeFrame: Up to 12 weeks
measure: Patient Satisfaction with Treatment and Aesthetic Appearance
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: K. Kay Durairaj, MD, A Medical Corp.
state: California
Study officials:
affiliation: K. Kay Durairaj, MD, A Medical Corp.
name: Kalpna K Durairaj, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanna E, Xing L, Taylor JH, Bertucci V. Role of botulinum toxin A in improving facial erythema and skin quality. Arch Dermatol Res. 2022 Oct;314(8):729-738. doi: 10.1007/s00403-021-02277-0. Epub 2021 Sep 14.
citation: Shin DM, Lee J, Noh H, Jang D, Oh SJ, Park JH, Lee JH. A Double-Blind, Split-Face, Randomized Study on the Effects and Safety of Intradermal Injection of Botulinum Toxin A (Incobotulinum Toxin A) in the Cheek. Ann Dermatol. 2022 Dec;34(6):442-450. doi: 10.5021/ad.21.316.
citation: Shuo L, Ting Y, KeLun W, Rui Z, Rui Z, Hang W. Efficacy and possible mechanisms of botulinum toxin treatment of oily skin. J Cosmet Dermatol. 2019 Apr;18(2):451-457. doi: 10.1111/jocd.12866. Epub 2019 Jan 29.
citation: Eiben-Nielson C, Kerscher M. Development and validation of a global photonumeric scale for evaluating skin quality of aged female facial skin. J Cosmet Dermatol. 2021 Dec;20(12):4032-4039. doi: 10.1111/jocd.14058. Epub 2021 Mar 24.
citation: Park JY, Cho SI, Hur K, Lee DH. Intradermal Microdroplet Injection of Diluted Incobotulinumtoxin-A for Sebum Control, Face Lifting, and Pore Size Improvement. J Drugs Dermatol. 2021 Jan 1;20(1):49-54. doi: 10.36849/JDD.5616.
citation: Fabi SG, Park JY, Goldie K, Wu W. Microtoxin for Improving Pore Size, Skin Laxity, Sebum Control, and Scars: A Roundtable on Integrating Intradermal Botulinum Toxin Type A Microdoses Into Clinical Practice. Aesthet Surg J. 2023 Aug 17;43(9):1015-1024. doi: 10.1093/asj/sjad044.
citation: Diaspro A, Calvisi L, Manzoni V, Sito G. Microbotulinum: A Quantitative Evaluation of Aesthetic Skin Improvement in 62 Patients. Plast Reconstr Surg. 2020 Nov;146(5):987-994. doi: 10.1097/PRS.0000000000007248.