NCT05456087

Use of Botulinum Toxin in the Treatment of Androgenic Alopecia

Active, enrolled Phase 2 Last updated 25 March 2024

What this trial tests

Phase 2 trial testing incobotulinumtoxin A in Androgenetic Alopecia in 20 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

12 August 2022

Primary endpoint
1 December 2024

1 December 2024

Quick facts

Lead sponsor	Zel Skin and Laser Specialists
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	12 August 2022
Primary completion	1 December 2024
Estimated completion	1 December 2024
Sites	1 location across United States

Drugs / interventions tested

• incobotulinumtoxin A — full drug profile →

Conditions studied

• Androgenetic Alopecia — all drugs for Androgenetic Alopecia →

Sponsor

Zel Skin and Laser Specialists

Who can join

Adults 22 to 55, any sex, with Androgenetic Alopecia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Changes from baseline in hair count per cm2 (number of hairs per follicular unit)
  Time frame: Day 30, Day 90, Day 180, and Day 270
  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.
• Changes from baseline in sum of hair width per cm2 (total scalp coverage)
  Time frame: Day 30, Day 90, Day 180, and Day 270
  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.
• Changes from baseline in Terminal:Vellus ratio (number of terminal hairs for every one vellus hair).
  Time frame: Day 30, Day 90, Day 180, and Day 270
  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.
• Changes from baseline in Average hairs per follicular unit (average number of hairs within a hair follicle).
  Time frame: Day 30, Day 90, Day 180, and Day 270
  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.
• Changes from baseline in Average hair width (microns) (average thickness of hair in microns).
  Time frame: Day 30, Day 90, Day 180, and Day 270
  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.
• Changes from baseline in Follicle count per cm2 (number of follicles per square centimeter).
  Time frame: Day 30, Day 90, Day 180, and Day 270
  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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.