A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines
Public ClinicalTrials.gov record NCT05152576. 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 2, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA X for Forehead Lines
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines. Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States. Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.
Study identification
- NCT ID
- NCT05152576
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Nov 28, 2021
- Primary completion
- Sep 5, 2022
- Completion
- Sep 5, 2022
- Last update posted
- Jul 15, 2025
2021 – 2022
United States locations
- U.S. sites
- 8
- U.S. states
- 4
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Eye Research Foundation /ID# 241512 | Newport Beach | California | 92663-3637 | — |
| Steve Yoelin MD Medical Associate Inc /ID# 239771 | Newport Beach | California | 92663 | — |
| The Center for Dermatology Cosmetics & Laser Surgery /ID# 239776 | Mount Kisco | New York | 10549-3028 | — |
| Skin Search of Rochester Inc. /ID# 239773 | Rochester | New York | 14623 | — |
| Dermatology Consulting Service /ID# 239779 | High Point | North Carolina | 27262 | — |
| Wilmington Dermatology Center /ID# 239778 | Wilmington | North Carolina | 28403 | — |
| Dallas Plastic Surgery Institute /ID# 239777 | Dallas | Texas | 75231 | — |
| Duplicate_Austin Institute for Clinical Research /ID# 239783 | 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 NCT05152576, 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 Jul 15, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05152576 live on ClinicalTrials.gov.