Use of Botulinum Toxin in the Treatment of Androgenic Alopecia

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05456087
Study type	Interventional
Source	Zel Skin and Laser Specialists
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	August 12, 2022
Completion date	December 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.