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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-post: abbvieclinicaltrials@abbvie.com
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100032
- Rekruttering
- Peking Union Medical College Hospital (West) - Xidan Campus /ID# 267457
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Guangdong
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Guangzhou, Guangdong, Kina, 510280
- Rekruttering
- Zhujiang Hospital /ID# 276566
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Shenzhen, Guangdong, Kina, 518036
- Rekruttering
- Peking University Shenzhen Hospital /ID# 268255
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Jiangsu
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Nanjing, Jiangsu, Kina, 210008
- Rekruttering
- Nanjing Drum Tower Hospital /ID# 267555
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Nanjing, Jiangsu, Kina, 210009
- Rekruttering
- Zhongda Hospital Of Southeast University /ID# 276571
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Shaanxi
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Xianyang, Shaanxi, Kina, 712000
- Rekruttering
- Xianyang Hospital of Yanan University /ID# 267936
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With Responder Status Based on Evaluating Investigator's Live Assessment of Nasolabial Fold Severity Scale (NLFSS)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: ABBVIE INC., AbbVie
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- M23-066
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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