Use of Botulinum Toxin in the Treatment of Androgenic Alopecia

NCT05456087 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: ZEL-IIT5773
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Androgenetic Alopecia

Keywords

Patterned Hair Loss

Outcome Measures

Primary Outcomes (7)

• Changes from baseline in hair count per cm2 (number of hairs per follicular unit)

  Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline hair count per cm2 will be compared to day 30, day 90, day 180 and day 270.

  Day 30, Day 90, Day 180, and Day 270

• Changes from baseline in sum of hair width per cm2 (total scalp coverage)

  Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline sum of hair width per cm2 will be compared to day 30, day 90, day 180 and day 270.

  Day 30, Day 90, Day 180, and Day 270

• Changes from baseline in Terminal:Vellus ratio (number of terminal hairs for every one vellus hair).

  Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline Terminal:Vellus ratio will be compared to day 30, day 90, day 180 and day 270.

  Day 30, Day 90, Day 180, and Day 270

• Changes from baseline in Average hairs per follicular unit (average number of hairs within a hair follicle).

  Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline average hairs per follicular unit will be compared to day 30, day 90, day 180 and day 270.

  Day 30, Day 90, Day 180, and Day 270

• Changes from baseline in Average hair width (microns) (average thickness of hair in microns).

  Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline average hair width (microns) will be compared to day 30, day 90, day 180 and day 270.

  Day 30, Day 90, Day 180, and Day 270

• Changes from baseline in Follicle count per cm2 (number of follicles per square centimeter).

  Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline follicle count per cm2 will be compared to day 30, day 90, day 180 and day 270.

  Day 30, Day 90, Day 180, and Day 270

• Mean Inter-follicular distance (mm) (mean distance between follicular units).

  Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline mean inter-follicular distance (mm) will be compared to day 30, day 90, day 180 and day 270.

  Day 30, Day 90, Day 180, and Day 270

Secondary Outcomes (8)

• Change from baseline in balding scalp hair recovery assessed by study investigator

  Day 30

• Change from baseline in balding scalp hair recovery assessed by study investigator

  Day 90

• Change from baseline in balding scalp hair recovery assessed by study investigator

  Day 180

• Change from baseline in balding scalp hair recovery assessed by study investigator

  Day 270

• Change from baseline in balding scalp hair recovery assessed by study participant

  Day 30

Study Arms (1)

Single treatment with Xeomin® (incobotulinumtoxin A)

EXPERIMENTAL

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.

Drug: incobotulinumtoxin A

Interventions

incobotulinumtoxin A DRUG

Up to 150 units of incobotulinumtoxin A will be injected at up to 30 injection sites within the hair loss area

Also known as: Xeomin

Single treatment with Xeomin® (incobotulinumtoxin A)

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zel Skin and Laser Specialists: lead
• Merz Aesthetics Inc.: collaborator

Study Sites (1)

ZelSkin and Laser Specialists

Edina, Minnesota, 55424, United States

Location

Related Publications (35)

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MeSH Terms

Conditions

Alopecia

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: July 13, 2022
• Study Start: August 12, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

US (1)