Single treatment with Xeomin® (incobotulinumtoxin A) for Androgenetic Alopecia (AGA)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Zel Skin and Laser Specialists, Edina, MN
Androgenetic Alopecia (AGA)+2 More
incobotulinumtoxin A - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to evaluate the effect of using a purified botulinum toxin (Xeomin®, Merz, USA), the same injectable used to improve face wrinkles, to treat a specific type of hair loss seen in men and women not associated with scarring or other internal disease called 'pattern hair loss'. This type of hair loss is medically called 'androgenic or androgenetic alopecia'. In men it is typically called 'male pattern baldness' whereas in women it is called 'female pattern baldness' and in both cases is hereditary meaning there will be a history of relatives that describe having the same condition.

Eligible Conditions

  • Androgenetic Alopecia (AGA)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Androgenetic Alopecia (AGA)

Study Objectives

7 Primary · 2 Secondary · Reporting Duration: Day 30, Day 90, Day 180, and Day 270

Day 270
Change from baseline in balding scalp hair recovery assessed by study investigator
Change from baseline in balding scalp hair recovery assessed by study participant
Day 270
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).
Changes from baseline in Terminal:Vellus ratio (number of terminal hairs for every one vellus hair).
Changes from baseline in hair count per cm2 (number of hairs per follicular unit)
Changes from baseline in sum of hair width per cm2 (total scalp coverage)
Mean Inter-follicular distance (mm) (mean distance between follicular units).

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Androgenetic Alopecia (AGA)

Trial Design

1 Treatment Group

Single treatment with Xeomin® (incobotulinumtoxin A)
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Single treatment with Xeomin® (incobotulinumtoxin A) · No Placebo Group · Phase 2

Single treatment with Xeomin® (incobotulinumtoxin A)
Drug
Experimental Group · 1 Intervention: incobotulinumtoxin A · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
incobotulinumtoxin A
2014
Completed Phase 2
~80

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 30, day 90, day 180, and day 270

Trial Background

Brian Zelickson, Principal Investigator
Principal Investigator
Zel Skin and Laser Specialists
Closest Location: Zel Skin and Laser Specialists · Edina, MN
2009First Recorded Clinical Trial
1 TrialsResearching Androgenetic Alopecia (AGA)
6 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must sign a photo release form before participating in this study.
Subjects must be diagnosed with mild to moderate degree of hair-pattern loss (androgenic alopecia).
Subjects must be between 22 and 45 years of age with mild to moderate AGA.
Subjects must agree to maintain the same hair grooming and style routine during study participation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References