Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture
NCT ID: NCT06604832
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2024-09-03
2025-09-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines
NCT05320393
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
NCT03014635
To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines
NCT01791920
The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
NCT05364580
A Study Comparing the Safety, Efficacy, and Diffusion of Letibotulinum Toxin A Versus Other Botulinum Toxin Products in Adults With Moderate-to-Severe Forehead Wrinkles
NCT07072806
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treated with prabotulinumtoxinA-xvfs and placebo
Subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12. Approximately 20 units of prabotulinumtoxinA-xvfs will be injected into the left side of the subject's glabellar lines and forehead region, and a placebo saline treatment will be injected into the right side of the subject's glabellar lines and forehead region.
PrabotulinumtoxinA-Xvfs
Each vial of prabotulinumtoxinA-xvfs contains 100 units of product, and it will be reconstituted with 5 mL of bacteriostatic saline solution. 20 units of this intervention will only be injected to the left side of subject faces - intramuscularly to the corrugator supercilii and intradermally to the forehead region.
saline solution (placebo)
As a placebo treatment, saline solution will be injected on the right side of the glabellar lines and forehead region instead of an active neuromodulator. The saline solution has no therapeutic effect and is used as a control to compare the results against the active treatment.
Treated with prabotulinumtoxinA-xvfs and incobotulinumtoxinA
Subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12. Approximately 20 units of prabotulinumtoxinA-xvfs will be injected into the left side of the subject's glabellar lines and forehead region, and approximately 20 units of incobotulinumtoxinA will be injected into the right side of the subject's glabellar lines and forehead region.
PrabotulinumtoxinA-Xvfs
Each vial of prabotulinumtoxinA-xvfs contains 100 units of product, and it will be reconstituted with 5 mL of bacteriostatic saline solution. 20 units of this intervention will only be injected to the left side of subject faces - intramuscularly to the corrugator supercilii and intradermally to the forehead region.
IncobotulinumtoxinA
Each vial of incobotulinumtoxinA contains 100 units of product, and it will be reconstituted with 5 mL of bacteriostatic saline solution. 20 units of this intervention will only be injected to the right side of subject faces - intramuscularly to the corrugator supercilii and intradermally to the forehead region.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PrabotulinumtoxinA-Xvfs
Each vial of prabotulinumtoxinA-xvfs contains 100 units of product, and it will be reconstituted with 5 mL of bacteriostatic saline solution. 20 units of this intervention will only be injected to the left side of subject faces - intramuscularly to the corrugator supercilii and intradermally to the forehead region.
IncobotulinumtoxinA
Each vial of incobotulinumtoxinA contains 100 units of product, and it will be reconstituted with 5 mL of bacteriostatic saline solution. 20 units of this intervention will only be injected to the right side of subject faces - intramuscularly to the corrugator supercilii and intradermally to the forehead region.
saline solution (placebo)
As a placebo treatment, saline solution will be injected on the right side of the glabellar lines and forehead region instead of an active neuromodulator. The saline solution has no therapeutic effect and is used as a control to compare the results against the active treatment.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Evolus, Inc.
INDUSTRY
Kalpna Kay Durairaj, MD, FACS
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kalpna Kay Durairaj, MD, FACS
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kalpna K Durairaj, MD
Role: PRINCIPAL_INVESTIGATOR
K. Kay Durairaj, MD, A Medical Corp.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
K. Kay Durairaj, MD, A Medical Corp.
Pasadena, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KDEJ24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.