Use of Botulinum Toxin in the Treatment of Androgenic Alopecia

Study Overview
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Brief Summary
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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.

Detailed Description
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Adult volunteers aged 22-45 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.

Official Title
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Use of Botulinum Toxin in the Treatment of Androgenic Alopecia

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: incobotulinumtoxin A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 22-45 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single treatment with Xeomin® (incobotulinumtoxin A)<br>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<br>* Up to 150 units of incobotulinumtoxin A will be injected at up to 30 injection sites within the hair loss area<br>* Other names: Xeomin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in balding scalp hair recovery assessed by study investigator | Hair recovery will be assessed by the study investigator on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 30 | 
| Change from baseline in balding scalp hair recovery assessed by study investigator | Hair recovery will be assessed by the study investigator on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 90 | 
| Change from baseline in balding scalp hair recovery assessed by study investigator | Hair recovery will be assessed by the study investigator on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 180 | 
| Change from baseline in balding scalp hair recovery assessed by study investigator | Hair recovery will be assessed by the study investigator on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 270 | 
| Change from baseline in balding scalp hair recovery assessed by study participant | Hair recovery will be assessed by the study participant on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 30 | 
| Change from baseline in balding scalp hair recovery assessed by study participant | Hair recovery will be assessed by the study participant on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 90 | 
| Change from baseline in balding scalp hair recovery assessed by study participant | Hair recovery will be assessed by the study participant on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 180 | 
| Change from baseline in balding scalp hair recovery assessed by study participant | Hair recovery will be assessed by the study participant on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 270 |