A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines
Public ClinicalTrials.gov record NCT05496335. 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 1 Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) in Subjects for Treatment of Glabellar Lines
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. The purpose of this study is to assess how safe and effective sequential administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) is in adult participants with moderate to severe GL. AGN-151586 is an investigational product being developed for the treatment of GL. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. One group will receive AGN-151586 followed by BOTOX and the other group will receive placebo followed by BOTOX. There is a 1 in 2 chance that participants will be assigned to placebo. Around 80 adult participants with moderate to severe GL will be enrolled in the study in approximately 10 sites around the United States. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive BOTOX injections on Day 30 and will be followed for up to 4 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05496335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 90 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
- Aug 29, 2022
- Primary completion
- May 29, 2023
- Completion
- May 29, 2023
- Last update posted
- Jun 25, 2026
2022 – 2023
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Eye Research Foundation /ID# 244430 | Newport Beach | California | 92663-3637 | — |
| Cosmetic Laser Dermatology /ID# 244425 | San Diego | California | 92121-2119 | — |
| AboutSkin Research, LLC /ID# 244416 | Greenwood Village | Colorado | 80111 | — |
| Skin Research Institute LLC /ID# 244424 | Coral Gables | Florida | 33146-1837 | — |
| Skin and Cancer Associates, LLP /ID# 244415 | Miami | Florida | 33137-3254 | — |
| DeNova Research /ID# 244421 | Chicago | Illinois | 60611 | — |
| Advanced Dermatology /ID# 244427 | Lincolnshire | Illinois | 60069 | — |
| Laser and Skin Surgery Center of Indiana /ID# 244423 | Indianapolis | Indiana | 46260-2386 | — |
| Bellaire Dermatology Associates /ID# 244428 | Bellaire | Texas | 77401 | — |
| Premier Clinical Research /ID# 244429 | Spokane | Washington | 99202 | — |
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 NCT05496335, 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 25, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05496335 live on ClinicalTrials.gov.