A Study to Assess the Safety and Efficacy of AGN-151586 Injections for the Treatment of Moderate to Severe Forehead Lines (FHL) in Adult Participants
Purpose
The objective of this study is to evaluate the safety and efficacy of AGN-151586 for the treatment of moderate to severe forehead lines (FHL) in adult participants.
Condition
- Forehead Lines
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participant must have moderate (Grade 2) or severe (Grade 3) forehead lines (FHL) at maximum eyebrow elevation as assessed by the subject and investigator using Forehead Lines Severity Scale (FHLSS) at Screening visit and Baseline Day 1 visit. - Participant must have moderate (Grade 2) or severe (Grade 3) glabellar lines (GL) at maximum frown as assessed by the subject and investigator using Allergan Glabellar Lines Severity Scale (AGLSS) at Screening visit and Baseline Day 1 visit. - Sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their FHL and GL in investigator's opinion.
Exclusion Criteria
- Clinically relevant or significant ECG abnormalities. - Active infection or dermatological condition at any of the treatment injection sites.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Open-Label AGN-151586 |
Participants will receive a single treatment of AGN-151586 on Day 1. |
|
Recruiting Locations
Eye Research Foundation /ID# 282193
Newport Beach, California 92663
Newport Beach, California 92663
Private Practice - Dr. Steven G. Yoelin /ID# 282334
Newport Beach, California 92663
Newport Beach, California 92663
Luxurgery /ID# 282336
New York, New York 10021
New York, New York 10021
Wilmington Dermatology Center /ID# 282192
Wilmington, North Carolina 28403
Wilmington, North Carolina 28403
Austin Institute for Clinical Research - Pflugerville /ID# 282195
Pflugerville, Texas 78660
Pflugerville, Texas 78660
More Details
- Status
- Recruiting
- Sponsor
- AbbVie