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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: ABBVIE CALL CENTER
- Numéro de téléphone: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Lieux d'étude
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100032
- Recrutement
- Peking Union Medical College Hospital (West) - Xidan Campus /ID# 267457
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Guangdong
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Guangzhou, Guangdong, Chine, 510280
- Recrutement
- Zhujiang Hospital /ID# 276566
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Shenzhen, Guangdong, Chine, 518036
- Recrutement
- Peking University Shenzhen Hospital /ID# 268255
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Jiangsu
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Nanjing, Jiangsu, Chine, 210008
- Recrutement
- Nanjing Drum Tower Hospital /ID# 267555
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Nanjing, Jiangsu, Chine, 210009
- Recrutement
- Zhongda Hospital Of Southeast University /ID# 276571
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Shaanxi
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Xianyang, Shaanxi, Chine, 712000
- Recrutement
- Xianyang Hospital of Yanan University /ID# 267936
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants With Responder Status Based on Evaluating Investigator's Live Assessment of Nasolabial Fold Severity Scale (NLFSS)
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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)
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: ABBVIE INC., AbbVie
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- M23-066
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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