What side effects are associated with this type of intervention?

Common treatments for Male Pattern Baldness, such as botulinum toxin injections (e.g., Xeomin®), are generally well-tolerated but can cause localized pain, headaches, temporary muscle weakness, and rare allergic reactions. Minoxidil may lead to scalp irritation, itching, and unwanted facial hair growth. Finasteride can cause sexual dysfunction, depression, and a small risk of high-grade prostate cancer.

What prior FDA approvals exist?

The FDA has approved two primary treatments for Male Pattern Baldness: minoxidil and finasteride. Minoxidil is a topical solution that enhances blood flow to hair follicles, promoting hair growth. Finasteride is an oral medication that prevents the conversion of testosterone to dihydrotestosterone (DHT), a hormone associated with hair loss. These treatments differ from botulinum toxin, such as Xeomin®, which is being studied for its potential to improve blood flow to the scalp by blocking acetylcholine release and relaxing muscles.

What other types of research exist?

Promising novel alternatives to Xeomin® for male pattern baldness include: <ol> <li>Platelet-Rich Plasma (PRP) Therapy: Utilizes the patient's own blood to stimulate hair growth through growth factors.</li> <li>Low-Level Laser Therapy (LLLT): Uses laser light to stimulate hair follicles and improve hair density.</li> <li>Stem Cell Therapy: Involves the use of stem cells to promote hair follicle regeneration.</li> <li>Topical Minoxidil with Enhanced Delivery Systems: New formulations that improve the penetration and efficacy of minoxidil.</li> <li>Oral Finasteride Alternatives: Newer drugs that inhibit DHT with fewer side effects.</li> </ol>

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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

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial uses an injectable treatment known for reducing wrinkles to treat hereditary hair loss in adults. The injections are given in the scalp and may help improve hair growth by affecting muscles and blood flow.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30, day 90, day 180, and day 270

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

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

Primary study objectives

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 study objectives

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%

Study treatment Arm

Placebo

Incobotulinum Toxin Injection

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Male Pattern Baldness (MPB) include minoxidil, finasteride, and botulinum toxin. Minoxidil is a topical treatment that promotes hair growth by widening blood vessels, which improves blood flow to hair follicles. Finasteride is an oral medication that inhibits the enzyme 5-alpha-reductase, reducing the conversion of testosterone to dihydrotestosterone (DHT), a hormone that shrinks hair follicles. Botulinum toxin, such as Xeomin®, works by blocking the release of acetylcholine, leading to muscle relaxation and potentially improving blood flow to the scalp. These mechanisms are crucial for MPB patients as they target different aspects of hair loss, from hormonal influences to blood circulation, offering a multifaceted approach to managing and potentially reversing hair loss.

Is there a therapeutic effect of botulinum toxin on scalp alopecia? Physiopathology and reported cases: A systematic review of the literature.