Microtox for Skin Aging

Phase 1

Recruiting

Led By Kalpna K Durairaj, MD

Research Sponsored by Kalpna Kay Durairaj, MD, FACS

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Significant dermatological conditions affecting the face

Previous cosmetic procedures near the forehead within the last 6 months or botulinum toxin treatments within the last 4 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Summary

"This trial aims to see if microtox can improve facial skin quality, wrinkles, and texture. Participants will be split into two groups and receive different treatments on each side of their face. They will

Who is the study for?

This trial is for individuals with facial wrinkles and signs of skin aging. Participants will be treated on one side of their forehead with a neuromodulator and the other side with either saline solution or a different brand of neuromodulator.

What is being tested?

The study tests microtox's effectiveness in improving facial skin quality, fine wrinkles, and texture by comparing two groups: one receiving a placebo on one forehead side and the other receiving two different neuromodulators on each side.

What are the potential side effects?

Possible side effects may include temporary muscle weakness, bruising at injection sites, headache, or eyelid drooping. Side effects are generally mild to moderate and resolve without intervention.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious skin conditions affecting my face.

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I haven't had cosmetic procedures near my forehead or Botox in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Global Aesthetic Improvement Scale (GAIS) Rating

Patient Satisfaction with Treatment and Aesthetic Appearance

Scientific Assessment Scale of Skin Quality (SASSQ) Rating

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treated with prabotulinumtoxinA-xvfs and incobotulinumtoxinAActive Control2 Interventions

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.

Group II: Treated with prabotulinumtoxinA-xvfs and placeboPlacebo Group2 Interventions

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.

0 / 2Eligibility criteria met