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Neurotoxin

Botulinum Toxin for Androgenic Alopecia

Phase 2
Waitlist Available
Research Sponsored by Zel Skin and Laser Specialists
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30, day 90, day 180, and day 270
Awards & highlights

Study Summary

This trial will test whether botulinum toxin can help treat pattern hair loss.

Who is the study for?
This trial is for men and women aged 22-45 with mild to moderate hereditary hair loss, who haven't had systemic hair loss treatments in the last 6 months. Participants must maintain their current hair routine, sign consent forms, and if female and able to have children, use contraception or remain sexually inactive.Check my eligibility
What is being tested?
The study tests Xeomin®, a botulinum toxin used for facial wrinkles, as a treatment for pattern baldness (androgenic alopecia) in adults. It aims to see if this injectable can improve hair growth by assessing participants before and after treatment.See study design
What are the potential side effects?
Potential side effects may include reactions at injection sites like pain or swelling, muscle weakness near treated areas, allergic reactions similar to other botulinum toxins such as Botox® or Dysport®, and general symptoms like fatigue or headache.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30, day 90, day 180, and day 270
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30, day 90, day 180, and day 270 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes from baseline in Average hair width (microns) (average thickness of hair in microns).
Changes from baseline in Average hairs per follicular unit (average number of hairs within a hair follicle).
Changes from baseline in Follicle count per cm2 (number of follicles per square centimeter).
+4 more
Secondary outcome measures
Change from baseline in balding scalp hair recovery assessed by study investigator
Change from baseline in balding scalp hair recovery assessed by study participant

Side effects data

From 2020 Phase 2 trial • 21 Patients • NCT02107261
33%
Weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Incobotulinum Toxin Injection

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single treatment with Xeomin® (incobotulinumtoxin A)Experimental Treatment1 Intervention
Individual balding scalps will be outlined and mapped to include up to 30 injection sites evenly distributed within the hair loss area. At each site, 5 Units of Xeomin® will be injected with a maximum of 150 Units total per subject. This will be a single, one-time treatment session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved

Find a Location

Who is running the clinical trial?

Zel Skin and Laser SpecialistsLead Sponsor
Merz Aesthetics Inc.Industry Sponsor
4 Previous Clinical Trials
568 Total Patients Enrolled

Media Library

incobotulinumtoxin A (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05456087 — Phase 2
Male Pattern Baldness Research Study Groups: Single treatment with Xeomin® (incobotulinumtoxin A)
Male Pattern Baldness Clinical Trial 2023: incobotulinumtoxin A Highlights & Side Effects. Trial Name: NCT05456087 — Phase 2
incobotulinumtoxin A (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456087 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has incobotulinumtoxin A attained regulatory acceptance by the FDA?

"Based on our risk assessment, incobotulinumtoxin A received a score of 2 due to limited evidence regarding its efficacy but some data demonstrating safety."

Answered by AI

Are there any vacancies for potential participants in this clinical trial?

"Affirmative. According to information on clinicaltrials.gov, this medical research is currently looking for volunteers. First posted on August 12th 2022, the trial was updated as recently as October 3rd of the same year and requires 20 individuals from 2 sites in total."

Answered by AI

How many persons are being included in the current clinical trial?

"Affirmative. According to the information available on clinicaltrials.gov, this particular medical study posted on August 12th 2022 is still seeking participants. A total of 20 people are required from two distinct facilities for the trial's completion."

Answered by AI

Is the elderly population eligible for this investigation?

"Based on the requirements for participation, eligible individuals must be between 22 and 45 years old."

Answered by AI

What types of individuals are most suitable for this research?

"This clinical trial seeks to enrol 20 individuals aged between 22 and 45 with mild to moderate androgenetic alopecia. Furthermore, sexually active females of childbearing age must agree to use a medically-approved contraceptive while receiving study product. In addition, subjects are required sign an informed consent document, photo release form, confirm their diagnosis as agreed by the investigator, maintain the same hair grooming and style routine during the duration of the study (or remain sexually inactive if not practicing contraception)."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Zel Skin and Laser Specialists

Why did patients apply to this trial?

I am looking for help with gaining my hair back if it is possible. I've been experiencing hair thinning and hair loss and I would like to act before it gets too late.
PatientReceived 2+ prior treatments
~5 spots leftby Dec 2024