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Not yet recruiting NCT07730554

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

Phase II Interventional Forehead Lines

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AGN-151586.
Who it may be relevant to
Registry conditions: Forehead Lines. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Moderate to Severe Forehead Lines (FHL) in Adults

Overview

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.

Interventions

  • Drug AGN-151586
    Injection

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) [Time frame: Up to Approximately 42 Days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07730554 · M26-476

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗