AGN-151586 + OnabotulinumtoxinA for Frown Lines
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: AbbVie
No Placebo Group
Trial Summary
What is the purpose of this trial?The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL).
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Is the combination of AGN-151586 and OnabotulinumtoxinA safe for treating frown lines?
OnabotulinumtoxinA, used for treating facial lines, has been shown to be generally safe with a favorable benefit-risk profile, and is well tolerated by most patients. Some studies report minimal side effects, such as mild itching (pruritus), but these are rare.
12345How is the drug combination of AGN-151586 and OnabotulinumtoxinA unique for treating frown lines?
The combination of AGN-151586 and OnabotulinumtoxinA for treating frown lines is unique because it potentially offers a novel approach by combining two agents, where OnabotulinumtoxinA is already known for its effectiveness in reducing frown lines, and AGN-151586 may enhance or complement this effect, although specific details about AGN-151586's role are not provided in the available research.
12367Eligibility Criteria
This trial is for adults with moderate to severe frown lines who want to try new treatments. Participants should be healthy overall and not have any conditions that might interfere with the study or pose a risk when receiving injections in the face.Inclusion Criteria
I have moderate to severe frown lines according to a wrinkle scale.
Exclusion Criteria
I have an infection or skin condition where I will receive treatment injections.
Participant Groups
The study is testing AGN-151586 and OnabotulinumtoxinA, comparing their safety and effectiveness in treating frown lines. Some participants will receive the actual drugs while others may get a placebo as part of the study's design.
5Treatment groups
Experimental Treatment
Group I: Cohort 3: Placebo and OnabotulinumtoxinAExperimental Treatment2 Interventions
Participants will receive a single treatment of Placebo and OnabotulinumtoxinA.
Group II: Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinAExperimental Treatment2 Interventions
Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Group III: Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinAExperimental Treatment2 Interventions
Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Group IV: Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinAExperimental Treatment2 Interventions
Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Group V: Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinAExperimental Treatment2 Interventions
Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Eye Research Foundation /ID# 270827Newport Beach, CA
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Who is running the clinical trial?
AbbVieLead Sponsor
References
A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. [2021]To investigate the efficacy and safety of incobotulinumtoxinA (also known as botulinum toxin type A [150 kDa], free from complexing proteins, or previously as NT 201), for the treatment of glabellar frown lines, in a prospective, open-label, multicenter, Phase III trial.
A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines. [2018]IncobotulinumtoxinA and onabotulinumtoxinA are indicated for the temporary improvement in the appearance of glabellar frown lines (GFL). This is the first randomized direct comparator study to date, at the Food and Drug Administration-recommended dose of 20 units (U), for the treatment of GFL.
Phase IV study comparing incobotulinumtoxinA and onabotulinumtoxinA using a 1:1.5 dose-conversion ratio for the treatment of glabellar frown lines. [2022]IncobotulinumtoxinA and onabotulinumtoxinA are effective treatments for glabellar frown lines, and a dose of 20 U is recommended for both preparations. However, debate continues over using the same dosages of these products, although a 1:1 dose ratio has been proven in several head-to-head clinical trials in neurological and esthetic indications.
Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. [2022]OnabotulinumtoxinA for the treatment of facial lines is a widely used cosmetic medical procedure and, as such, the safety and tolerability profile is of interest to health care providers and patients. Based on data from individual studies that were conducted according to regulatory guidelines to provide adequate safety and efficacy data to support product licensure (registration studies), the overall benefit:risk profile of onabotulinumtoxinA for facial lines has been favorable.
Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. [2018]OnabotulinumtoxinA is one of the most widely used agents for cosmetic and medical treatment. Studies have shown that onabotulinumtoxinA is safe and effective with minimal adverse events, and is often well tolerated by patients. We present a patient who developed neuropathic pruritus five days after treatment with onabotulinumtoxinA for neuromuscular pain. This case highlights the treatment of pruritus associated with onabotulinumtoxinA and the therapeutic method to resolve the patient's pruritus.
Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines. [2022]OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs.
Onset and duration of effect of incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA in the treatment of glabellar frown lines: a randomized, double-blind study. [2021]Three botulinum neurotoxin type A preparations (incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA) are widely approved in Europe and in the US for the treatment of glabellar frown lines. The purpose of this study was to determine and compare the time to onset and duration of treatment effect of incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA for the treatment of glabellar frown lines.