Botulinum Toxin for Androgenic Alopecia

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a purified form of botulinum toxin, commonly used for facial wrinkles, can help with pattern hair loss (androgenic alopecia) in both men and women. The study aims to determine if a single treatment with incobotulinumtoxin A can improve hair growth in areas with mild to moderate thinning. Individuals with a family history of pattern baldness and mild to moderate hair loss might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage findings.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that botulinum toxin, such as Xeomin®, is safe for treating pattern hair loss, known as androgenic alopecia. In earlier studies, patients experienced no serious side effects from the injections. These studies reported positive outcomes for individuals with pattern hair loss, indicating the treatment is well-tolerated. Botulinum toxin is also safely used in other treatments, such as reducing facial wrinkles, further establishing its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pattern hair loss?

Unlike the standard treatments for androgenic alopecia, such as minoxidil and finasteride, which primarily focus on promoting hair growth or inhibiting hormone-related hair loss, incobotulinumtoxin A (Xeomin®) offers a novel approach. Researchers are intrigued because this treatment utilizes botulinum toxin, which is more commonly known for its use in smoothing wrinkles, to potentially improve blood flow and nutrient delivery to hair follicles with a single session of targeted scalp injections. This innovative mechanism could offer a quick, one-time alternative to the daily or routine applications required by traditional therapies, sparking hope for more efficient and less burdensome management of hair loss.

What evidence suggests that this treatment might be an effective treatment for androgenic alopecia?

Research has shown that botulinum toxin, like the kind used in Xeomin®, may help treat androgenic alopecia, a common type of hair loss. In this trial, participants will receive a single treatment with Xeomin® (incobotulinumtoxin A). One study found that botulinum toxin was safe and effective, with 75% to 79.1% of people noticing changes in their hair. Another study demonstrated that botulinum toxin can help hair grow and reduce hair loss in various conditions. Overall, evidence suggests that botulinum toxin could be an innovative option for managing this type of hair loss in both men and women. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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

Participation in another research study within the last 30 days

I have had reactions to certain medications before.

Albumin sensitivity

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5782443/

A Pilot Study to Evaluate Effectiveness of Botulinum Toxin ... Conclusion: Botulinum toxin was found to be safe and effective therapy for the management of androgenetic alopecia in this pilot study. Studies with larger ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05456087?term=botulinum

Use of Botulinum Toxin in the Treatment of Androgenic ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352587823000566

Review Article Botulinum Toxin A for Hair Loss Treatment Efficacy of BoNT-A: BoNT-A has shown promising results in promoting hair growth and reducing hair loss in various types of hair loss conditions. BoNT-A can be ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35415183/

Use of Botulinum Toxin for Androgenic Alopecia Of the 4 studies measuring response rates (i.e., subjects with >0% hair changes), response rates ranged from 75 to 79.1%. Within studies measuring hair count ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.15972

Assessment of efficacy of different botulinum toxin A ... The results of the present study showed that BTA is a safe and effective treatment for AGA in both genders. These findings offer a cutting-edge ...

6. trialx.com trialx.com/clinical-trials/listings/259698/use-of-botulinum-toxin-in-the-treatment-of-androgenic-alopecia/

Use of Botulinum Toxin in the Treatment of Androgenic ... 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, ...