Use of Botulinum Toxin in the Treatment of Androgenic Alopecia

Last updated: March 25, 2024
Sponsor: Zel Skin and Laser Specialists
Overall Status: Active - Not Recruiting

Phase

2

Condition

Alopecia

Male Pattern Baldness

Hair Loss

Treatment

incobotulinumtoxin A

Clinical Study ID

NCT05456087
ZEL-IIT5773
  • Ages 22-55
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must be diagnosed by the investigator with mild to moderate degree ofhair-pattern loss (androgenic alopecia). Mild to moderate will be defined byinvestigator assessment of III Vertex-V on the Norwood Scale ( for males) or 3-6 onthe Savin Scale (for females).
  2. Subjects must be between 22-55 years of age with mild to moderate AGA with no knownmedical conditions that, in the investigator's opinion, may interfere with studyparticipation.
  3. Subjects must agree to maintain the same hair grooming and style routine during studyparticipation.
  4. Sexually active females of childbearing potential participating in the study mustagree to use a medically-acceptable method of contraception while receiving studyproduct. A woman of childbearing potential is defined as one who is biologicallycapable of becoming pregnant; including perimenopausal women who are less than 2 yearsfrom their last menses. Exception: Sexually inactive females of childbearing potentialare not required to practice a reliable method of contraception and may be enrolled atthe investigator's discretion, provided that they understand the possible risksinvolved in getting pregnant during the study and are counseled to remain sexuallyinactive for the duration of the study or to practice a reliable method ofcontraception if becoming sexually active during the study.
  5. Subjects must sign a written informed consent.
  6. Subjects must sign a photo release form.

Exclusion

Exclusion Criteria:

  1. Any systemic treatment for hair loss within the last 6 months including hormonaltherapy for peri-menopausal females.
  2. Concurrent therapy with any medication either topical or oral that might, in theinvestigator's opinion, interfere with the study.
  3. Subjects under current treatments in study area with light therapy, microneedling,Platelet-rich Plasma, prostaglandin analogues, ketoconazole, hair transplant or anymethod deemed unacceptable by the investigator.
  4. Any history of drug interaction, such as, aminoglycoside antibiotics, penicillamine,quinine and calcium channel blockers
  5. Subjects who have demonstrated a previous hypersensitivity reaction to any of theingredients of the study products.
  6. History of allergic reaction to similar products (Botox® or Dysport®)
  7. Albumin sensitivity (allergy to eggs)
  8. Subjects with any signs of infection at the injection sites
  9. Active cold or sinus infection
  10. Any dermatologic or systemic disorder, which in the investigator's opinion, mayinterfere with the treatment. Examples of such disorders include neuromusculardisorders, hypertrophic scarring, keloidal scarring, bleeding disorders, subjects onimmunosuppressive medications, and lupus erythematosus.
  11. Subjects who are pregnant, breast feeding or planning a pregnancy during the studyperiod.
  12. Subjects who are unwilling or unable to comply with the requirements of the protocol.
  13. Participation in another research study (currently or within the last 30 days).
  14. All volunteers unwilling to sign the consent forms after being informed of theirobligations and risks that they might encounter as a participant in this study.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: incobotulinumtoxin A
Phase: 2
Study Start date:
August 12, 2022
Estimated Completion Date:
December 31, 2024

Study Description

Adult volunteers aged 22-55 years presenting with mild to moderate patterned hair loss will be screened for participation. Twenty subjects (10 males and 10 females) meeting the inclusion/exclusion criteria will be recruited to participate. Prior to any injections a global photograph documenting the patterned hair loss will be acquired for each individual utilizing the Canfield global camera system. Each subject will then undergo trichoscopy imaging within the defined treatment area using the Canfield HairMetrix® system. The imaged area is at a higher magnification capable of reliable measurements for hair density (count/cm2), hair shaft diameter, follicular units, among other measurements captured by the software. 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. Consequently, subjects will be contacted by phone or will be asked to come into the clinic for follow up according to a set schedule.

At each follow up visit (monthly) subjects will be asked to report any adverse events. Follow up visits at the clinic will also include photographic documentation, trichoscopy, and investigator and subject subjective reporting of treatment progress.

There will be a total of up to 3 injectors, 1 person taking photographs (including trichoscopy), and 1 investigator assessing treatment outcome.

During this 9 month-long study, subjects cannot utilize other hair loss treatments and must maintain their grooming routine which includes maintaining their hair style.

Connect with a study center

  • ZelSkin and Laser Specialists

    Edina, Minnesota 55424
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.