Spread of PrabotulinumtoxinA-xvfs Versus OnabotulinumtoxinA in the Treatment of Forehead Rhytides

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Ten subjects will be enrolled in the study. Each subject will have their left and right forehead randomly assigned to receive 4 units of PrabotulinumtoxinA-xvfs or OnabotulinumtoxinA. Subjects will be reassessed at 2 weeks for evaluation of rhytide diminution around each injection point to assess relative diffusion of each drug in the forehead.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lupo Center for Aesthetic and General Dermatology
• Collaborator: Evolus, Inc.
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• 18-65 years of age

• Moderate-to-severe dynamic forehead rhytides and none-to-minimal static forehead rhytides (score of 3 to 4 and score of 0 to 1, respectively, using a 5-point validated grading scale for forehead lines)1

• Subjects in good general health based on investigator's judgment and medical history

• Willingness to have facial exams and photos performed

• Must be willing to give and sign an informed consent form and photographic release form

• Negative urine pregnancy test result at the time of study entry (if applicable)

• Must be willing to comply with study treatments and complete the entire course of the study

Exclusion Criteria:

• Pregnant or breastfeeding

• Previous treatment with botulinum toxin of any serotype in the forehead area within the last 6 months

• History of permanent or long-acting fillers such as silicone, Sculptra® or Radiesse® in the treatment area

• Current history of substance abuse, including alcohol or other drugs

• Concurrent use of medications that affect neuromuscular transmission such as aminoglycoside antibiotics, anticholinesterases, lincosamides and polymyxins

• Marked facial asymmetry

• History of facial nerve palsy

• Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)

• Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study

• Known allergy or hypersensitivity to botulinum toxin preparation

• Any planned surgical intervention to the face for the duration of the trial

• Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters

• Subjects with an active bacterial, viral, or fungal infection of the treatment areas

• Subjects with tattoos or excessive scarring in the treatment areas

• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study