COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Effects of PrabotulinumtoxinA-xvfs on Facial Skin Quality, Fine Wrinkles, and Texture

Quick Facts

Study Start:2024-09-03
Study Completion:2025-09-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06604832

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biological females, 18-65 years old, of any race and ethnic background
  2. * Individuals with mild to moderate facial wrinkles
  3. * All skin types (Fitzpatrick I-VI)
  4. * Willingness to participate and provide written informed consent
  5. * Ability to follow study instructions and likely to complete all required visits
  1. * Females who are pregnant, breastfeeding, chronically using nonsteroidal anti-inflammatory drugs, have autoimmune conditions or have a known allergy to the study medications.
  2. * Previous cosmetic procedures near the forehead within the last 6 months or botulinum toxin treatments within the last 4 months
  3. * Known neuromuscular disorders or a hypersensitivity to botulinum toxin
  4. * Significant dermatological conditions affecting the face
  5. * Use of medications affecting neuromuscular function or skin healing within 2 weeks prior to the beginning of study
  6. * 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.

Contacts and Locations

Principal Investigator

Kalpna K Durairaj, MD
PRINCIPAL_INVESTIGATOR
K. Kay Durairaj, MD, A Medical Corp.

Study Locations (Sites)

K. Kay Durairaj, MD, A Medical Corp.
Pasadena, California, 91105
United States

Collaborators and Investigators

Sponsor: Kalpna Kay Durairaj, MD, FACS

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-03
Study Completion Date2025-09-16

Study Record Updates

Study Start Date2024-09-03
Study Completion Date2025-09-16

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Skin Aging
  • Skin Wrinkling