A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
Public ClinicalTrials.gov record NCT05013424. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2a Multicenter Open-label Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA X in Subjects With Glabellar Lines
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Hyperfunctional facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. BOTOX (onabotulinumtoxinA) was first approved for aesthetic treatment of glabellar lines in 2001 and is one of the most common nonsurgical procedures in aesthetic medicine. This is a proof-of-concept study to evaluate how safe this new OnabotA X formulation is in treating adult participants with GL . OnabotA X is an onabotulinumtoxinA investigational product being developed for the treatment of moderate to severe glabellar lines (GL). This is a 180-day, open-label study to assess the safety of a single dose of 3 different formulations of OnabotA X (A, B \& C; each with varying amounts of the standard excipients in the formulation) in adult subjects with moderate to severe GL. Around 90 participants will be enrolled in the study in approximately 5 sites in the United States. Participants will receive one dose of OnabotA X administered as 5 injections on Day 1. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05013424
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 92 participants
Conditions and interventions
Conditions
Interventions
- Formulation A: OnabotulinumtoxinA Drug
- Formulation B: OnabotulinumtoxinA Drug
- Formulation C: OnabotulinumtoxinA Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2021
- Primary completion
- Jul 6, 2022
- Completion
- Jul 6, 2022
- Last update posted
- Jun 26, 2025
2021 – 2022
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Research Associates - Glendale /ID# 227368 | Glendale | Arizona | 85308 | — |
| Skin Research Institute LLC /ID# 227366 | Coral Gables | Florida | 33146-1837 | — |
| Etre Cosmetic Dermatology and Laser Center /ID# 227365 | New Orleans | Louisiana | 70130-4353 | — |
| The Center for Dermatology Cosmetics & Laser Surgery /ID# 227369 | Mount Kisco | New York | 10549-3028 | — |
| Austin Institute for Clinical Research /ID# 227367 | Pflugerville | Texas | 78660 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05013424, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 26, 2025 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05013424 live on ClinicalTrials.gov.