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

NCT06604832 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-21

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Evolus, Inc.

    collaborator INDUSTRY

  • Kalpna Kay Durairaj, MD, FACS

    lead OTHER

Principal Investigators

  • Kalpna K Durairaj, MD · K. Kay Durairaj, MD, A Medical Corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2025-08-29
Completion
2025-09-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604832 on ClinicalTrials.gov