Study to Assess Adverse Events and How Effective NOA LIFT is Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds in Adults
A Prospective Multi-Center, Evaluator- and Subject- Blinded, Randomized Study to Evaluate the Safety and Effectiveness of NOA LIFT Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds
Nasolabial folds (NLFs) are wrinkles that run from the sides of the nose to the corners of the mouth. The goal of this study is to evaluate how safe and effective NOA LIFT is compared to JUVÉDERM VOLIFT with Lidocaine for correcting moderate to severe nasolabial folds in adults.
NOA LIFT and JUVÉDERM VOLIFT with Lidocaine are hyaluronic acid-based dermal fillers being evaluated for the treatment of nasolabial folds. Participants are randomly placed into 1 of 2 treatment groups. There is a 2 in 3 chance that participants will be assigned to the NOA LIFT group and a 1 in 3 chance of being assigned to the VOLIFT group. Around 288 adult participants with moderate to severe nasolabial folds will be enrolled at multiple sites in China.
Participants will receive deep dermis injections of either NOA LIFT or JUVÉDERM VOLIFT. The study duration is approximately 12 months after the initial treatment.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, vital signs, laboratory tests, vision assessments, checking for side effects, and completing questionnaires.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-Mail: abbvieclinicaltrials@abbvie.com
Studienorte
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100032
- Rekrutierung
- Peking Union Medical College Hospital (West) - Xidan Campus /ID# 267457
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Guangdong
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Guangzhou, Guangdong, China, 510280
- Rekrutierung
- Zhujiang Hospital /ID# 276566
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Shenzhen, Guangdong, China, 518036
- Rekrutierung
- Peking University Shenzhen Hospital /ID# 268255
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- Rekrutierung
- Nanjing Drum Tower Hospital /ID# 267555
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Nanjing, Jiangsu, China, 210009
- Rekrutierung
- Zhongda Hospital Of Southeast University /ID# 276571
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Shaanxi
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Xianyang, Shaanxi, China, 712000
- Rekrutierung
- Xianyang Hospital of Yanan University /ID# 267936
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Moderate (2) or Severe (3) on the 5-point Nasolabial Fold Severity Scale (NLFSS) for each nasolabial fold (NLF) on evaluator live assessment (both sides must qualify and have the same score)
Exclusion Criteria:
- Current cutaneous or mucosal inflammatory or infectious processes, abscess, unhealed wound, or cancerous or precancerous lesion in the treatment area(s).
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days before enrollment.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: NOA LIFT
Participants will receive initial treatment with NOA LIFT injected into the nasolabial folds.
Optional touch-up treatment may be administered at Day 31 if optimal aesthetic correction has not been achieved.
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Injection
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Aktiver Komparator: JUVÉDERM VOLIFT With Lidocaine
Participants will receive initial treatment with JUVÉDERM VOLIFT with Lidocaine injected into the nasolabial folds.
Optional touch-up treatment may be administered at Day 31 if optimal aesthetic correction has not been achieved.
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Injection
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of Participants With Responder Status Based on Evaluating Investigator's Live Assessment of Nasolabial Fold Severity Scale (NLFSS)
Zeitfenster: Month 6
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The NLFSS is a validated 5-point scale used to assess the severity of nasolabial folds, where higher scores indicate more severe folds.
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Month 6
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Number of Participants With Adverse Events
Zeitfenster: Up to approximately 13 months
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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.
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Up to approximately 13 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of Participants With Responder Status Based on Evaluating Investigator's Assessment of Global Aesthetic Improvement Scale (GAIS) in Nasolabial Folds (NLFs)
Zeitfenster: Month 6
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A responder is defined as a participant with improvement in the GAIS in NLF (defined as improved or much improved in GAIS).
The GAIS is used to assess aesthetic improvement, with higher ratings indicating greater improvement.
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Month 6
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Percentage of Participants With Responder Status Based on Participant's Assessment of Global Aesthetic Improvement Scale (GAIS) in Nasolabial Folds (NLFs)
Zeitfenster: Month 6
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A responder is defined as a participant with improvement in the GAIS in NLF (defined as improved or much improved in GAIS).
The GAIS is used by participants to assess their own aesthetic improvement, with higher ratings indicating greater improvement.
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Month 6
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Change From Baseline in the Overall Score of FACE-Q - Appraisal of Lines: Nasolabial Folds
Zeitfenster: Up to Month 6
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The FACE-Q - Appraisal of Lines: Nasolabial Folds is a patient-reported outcome measure assessing satisfaction with nasolabial fold appearance.
Higher scores indicate better outcomes.
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Up to Month 6
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: ABBVIE INC., AbbVie
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- M23-066
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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