Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture

NCT06604832 | Completed Phase 1 FDA Drug

• 1 other identifier: KDEJ24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Skin Aging; Skin Wrinkling

Keywords

Microtox; Minimally invasive; Skin quality; Skin texture; Fine wrinkling; Botulinum toxin; PrabotulinumtoxinA-xvfs; Glabellar lines

Outcome Measures

Primary Outcomes (2)

• Scientific Assessment Scale of Skin Quality (SASSQ) Rating

  The treating physician and the blinded, secondary evaluator will rate the subject after the final treatment. The scale identifies 6 parameters of skin quality: (1) loss of elasticity, (2) wrinkles, (3) roughness, (4) pigmentation/lentigines, (5) erythema, and (6) pore size. The scale has 5 points to describe the intensity of parameters 1-5: 0 implies none, 1 implies mild, 2 implies moderate, 3 implies severe, and 4 implies very severe. For parameter 6, 0 implies fine, 1 implies small, 2 implies moderate, 3 implies large, and 4 implies very large.

  Up to 12 weeks

• Global Aesthetic Improvement Scale (GAIS) Rating

  The treating physician and the blinded, secondary evaluator will rate the subject after the final treatment. Based on aesthetic appearance, qualitative success of treatment will be evaluated using the GAIS. Aesthetic appearance will be rated one of the five following options: - Worse: The appearance is worse than the original condition - No Change: The appearance is essentially the same as the original condition - Improved: Obvious improvement in appearance from the initial condition, but a touchup or re-treatment is indicated - Much Improved: Marked improvement in appearance but not completely optimal for this patient. A touchup would slightly improve the result - Very Much Improved: Optimal cosmetic result for the treatment in this patient.

  Up to 12 weeks

Secondary Outcomes (5)

• Scientific Assessment Scale of Skin Quality (SASSQ) Rating

  Up to 2 weeks

• Global Aesthetic Improvement Scale (GAIS) Rating

  Up to 2 weeks

• Global Aesthetic Improvement Scale (GAIS) Rating

  Up to 12 weeks

• Scientific Assessment Scale of Skin Quality (SASSQ) Rating

  Up to 12 weeks

• Patient Satisfaction with Treatment and Aesthetic Appearance

  Up to 12 weeks

Study Arms (2)

Treated with prabotulinumtoxinA-xvfs and placebo

PLACEBO COMPARATOR

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.

Drug: PrabotulinumtoxinA-Xvfs; Drug: saline solution (placebo)

Treated with prabotulinumtoxinA-xvfs and incobotulinumtoxinA

ACTIVE COMPARATOR

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.

Drug: PrabotulinumtoxinA-Xvfs; Drug: IncobotulinumtoxinA

Interventions

PrabotulinumtoxinA-Xvfs DRUG

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.

Also known as: Jeuveau

Treated with prabotulinumtoxinA-xvfs and incobotulinumtoxinA; Treated with prabotulinumtoxinA-xvfs and placebo

IncobotulinumtoxinA DRUG

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.

Also known as: Xeomin

Treated with prabotulinumtoxinA-xvfs and incobotulinumtoxinA

saline solution (placebo) DRUG

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 placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Eligibility is determined by their biological sex, as there are distinct physiological differences between male and female skin. Due to these differences, individuals whose gender identity differs from their biological sex (i.e., transgender individuals) are excluded from the study to ensure consistency in data collection related to sex-specific skin characteristics.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kalpna Kay Durairaj, MD, FACS: lead
• Evolus, Inc.: collaborator

Study Sites (1)

K. Kay Durairaj, MD, A Medical Corp.

Pasadena, California, 91105, United States

Location

Related Publications (7)

• 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.

  PMID: 34519860 BACKGROUND

• 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.

  PMID: 36478426 BACKGROUND

• 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.

  PMID: 30697928 BACKGROUND

• 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.

  PMID: 33690945 BACKGROUND

• 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.

  PMID: 33400411 BACKGROUND

• 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.

  PMID: 36857534 BACKGROUND

• 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.

  PMID: 33136941 BACKGROUND

MeSH Terms

Interventions

prabotulinumtoxin A; incobotulinumtoxinA; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kalpna K Durairaj, MD

  K. Kay Durairaj, MD, A Medical Corp.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 20, 2024
• Study Start: September 3, 2024
• Primary Completion: August 29, 2025
• Study Completion: September 16, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available beginning 12 months and ending 28 months after article publication. Upon approval of a data sharing request, data will be accessible to researchers for up to 3 months.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in scientific research, and will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact research@beautybydrkay.com.

Locations

US (1)