Phase 2
N=198
AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines
Glabellar Lines
Bottom Line
View on ClinicalTrials.gov: NCT04096326 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 — 0.0; 40.6; 0.0; 46.4 percentage of participants — p=0.0096
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AGN-151586 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 |
0.0; 40.6; 0.0; 46.4; 18.2; 70.4 | 0.0096 sig |
| PRIMARY Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) |
3; 15; 7; 10; 7; 9 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention |
0; 7; 1; 5; 3; 4 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention |
2; 0; 0; 2; 1; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Anti-drug Antibodies (ADAs) |
0; 0; 0; 0; 0; 0 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe glabellar lines (GL).
Eligibility Criteria
Inclusion Criteria
-Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period (at least 10 weeks after study intervention).
Exclusion Criteria
- Known immunization or hypersensitivity to any botulinum neurotoxin serotype
- Any medical condition that may put the participant at increased risk with exposure to AGN-151586, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or the inability to substantially lessen facial lines even by physically spreading them apart, as determined by the investigator
- Any brow or eyelid ptosis, as determined by the investigator
- Infection or skin disorder at the injection sites
- History of facial nerve palsy
- Any uncontrolled systemic disease
- Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study intervention)
- Anticipated need for surgery or overnight hospitalization during the study
- Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery)
- Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Screening
Data sourced from ClinicalTrials.gov (NCT04096326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.