A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines
A Phase 1 Study to Evaluate the Safety and Efficacy of Sequential Administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)
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 drug being developed for treatment of moderate to severe glabellar lines. Participants are placed into 1 of 2 groups called treatment arms. In both arms participants will receive both AGN-151586 and BOTOX. Approximately 120 adult participants with moderate to severe glabellar lines enrolled in the study in approximately 8 sites around the United States.
Participants will receive injections of AGN-151586 on Day 1 in the glabellar complex. After meeting treatment criteria, participants in Cohort 1 will receive intramuscular injections of BOTOX on Day 14, and participants in Cohort 2 will receive intramuscular injections of BOTOX on Day 21. Participants will be followed for up to approximately 141 days.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-post: abbvieclinicaltrials@abbvie.com
Studieorter
-
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Arizona
-
Glendale, Arizona, Förenta staterna, 85308
- Rekrytering
- Advanced Research Associates - Glendale /ID# 283833
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California
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Newport Beach, California, Förenta staterna, 92663
- Rekrytering
- Eye Research Foundation /ID# 283835
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Vista, California, Förenta staterna, 92083
- Rekrytering
- Pacific Clinical Innovations /ID# 283812
-
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70130
- Rekrytering
- Etre, Cosmetic Dermatology And Laser Center /ID# 283831
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Massachusetts
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Chestnut Hill, Massachusetts, Förenta staterna, 02467
- Rekrytering
- Skincare Physicians /ID# 283851
-
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North Carolina
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Wilmington, North Carolina, Förenta staterna, 28403
- Rekrytering
- Wilmington Dermatology Center /ID# 283853
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37215
- Rekrytering
- Tennessee Clinical Research Center /ID# 283894
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-
Texas
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Pflugerville, Texas, Förenta staterna, 78660
- Rekrytering
- Austin Institute for Clinical Research - Pflugerville /ID# 283817
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline (Day 1) Visits
- Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, and 12-lead ECG parameters
- Must have sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their GL, in the opinion of the investigator.
Exclusion Criteria:
- Severe glabellar lines at rest as assessed by the investigator using the FWS
- Prior exposure to botulinum neurotoxin of any serotype within the last 12 months prior to screening
- History of hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Cohort 1 - AGN-151586 and BOTOX
Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 14.
|
Injection
Injection
|
|
Experimentell: Cohort 2 - AGN-151586 and BOTOX
Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 21.
|
Injection
Injection
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
Tidsram: Up to Approximately Day 141
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The investigator assesses the relationship of each event to the use of study drug and the study drug injection procedure.
|
Up to Approximately Day 141
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: ABBVIE INC., AbbVie
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- M26-479
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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