Botulinum Toxin for Androgenic Alopecia

Recruiting at 1 trial location

Overseen By Brian D Zelickson, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Zel Skin and Laser Specialists

Must not be taking: Hormonal therapy, Immunosuppressives

Disqualifiers: Pregnancy, Neuromuscular disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop any systemic treatment for hair loss and any medication that might interfere with the study. If you're on such treatments, you may need to stop them before participating.

What data supports the effectiveness of the drug incobotulinumtoxin A for treating androgenic alopecia?

Some studies suggest that botulinum toxin injections can improve hair growth in men with androgenic alopecia, with response rates between 75% and 79.1% and hair count changes from 18% to 20.9%. However, these studies lacked control groups and had small participant numbers, so more research is needed to confirm these findings. ^{1 2 3 4 5}

Is botulinum toxin safe for treating androgenic alopecia?

In studies involving botulinum toxin for androgenic alopecia, no serious adverse events were reported, suggesting it is generally safe for use in humans. ^{1 2 3 4 6}

How does the drug incobotulinumtoxin A differ from other treatments for androgenic alopecia?

Incobotulinumtoxin A is unique because it involves injecting botulinum toxin into the scalp muscles, which relaxes them and increases blood flow, potentially improving hair growth. This approach is different from standard treatments like finasteride and minoxidil, which work through hormonal pathways or direct stimulation of hair follicles. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

Subjects must sign a photo release form

I agree to use birth control during the study.

Subjects must agree to maintain the same hair grooming and style routine during study participation

Exclusion Criteria

I have had reactions to certain medications before.

Participation in another research study within the last 30 days

Albumin sensitivity

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Single, one-time treatment session with Xeomin® injections at up to 30 sites on the scalp

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with monthly follow-up visits

9 months

Monthly visits (in-person or phone)

Treatment Details

Interventions

• incobotulinumtoxin A

Trial Overview 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.

Participant Groups

Group I: Single treatment with Xeomin® (incobotulinumtoxin A) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Zel Skin and Laser Specialists

Lead Sponsor

Trials

1

Recruited

20+

Merz Aesthetics Inc.

Industry Sponsor

Trials

5

Recruited

590+

Findings from Research

OnabotulinumtoxinA is generally considered safe and effective for both cosmetic and medical treatments, with minimal adverse events reported.

A case study is presented where a patient experienced neuropathic pruritus five days after receiving onabotulinumtoxinA for neuromuscular pain, emphasizing the need for awareness and management of this potential side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. Ho, D., Jagdeo, J.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Botulinum Toxin for Androgenic Alopecia: A Systematic Review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A study of combination unilateral subcutaneous botulinum toxin a treatment for androgenetic alopecia. [2022]

3. India pubmed.ncbi.nlm.nih.gov

A Pilot Study to Evaluate Effectiveness of Botulinum Toxin in Treatment of Androgenetic Alopecia in Males. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Botulinum Toxin Type A in the Treatment of Androgenetic Alopecia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of non-surgical treatments for androgenetic alopecia in men and women: a systematic review with network meta-analyses, and an assessment of evidence quality. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. [2018]