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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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).
- 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.
- Subjects must agree to maintain the same hair grooming and style routine during studyparticipation.
- 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.
- Subjects must sign a written informed consent.
- Subjects must sign a photo release form.
Exclusion
Exclusion Criteria:
- Any systemic treatment for hair loss within the last 6 months including hormonaltherapy for peri-menopausal females.
- Concurrent therapy with any medication either topical or oral that might, in theinvestigator'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 anymethod 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 theingredients 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, mayinterfere with the treatment. Examples of such disorders include neuromusculardisorders, hypertrophic scarring, keloidal scarring, bleeding disorders, subjects onimmunosuppressive medications, and lupus erythematosus.
- Subjects who are pregnant, breast feeding or planning a pregnancy during the studyperiod.
- 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 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
Connect with a study center
ZelSkin and Laser Specialists
Edina, Minnesota 55424
United StatesSite 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.