Evaluate the Efficacy and Safety of INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
1. juni 2026 oppdatert av: INIBIO Co., Ltd.
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled Phase III Trial to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
To evaluate the efficacy and safety of botulinum toxin type A for injection INI101 compared to BOTOX® in subjects with moderate to severe glabellar lines.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
292
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Seoul, Sør -Korea
- INIBIO Co., Ltd.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Adult male or female participants aged between 19 and 65 years old.
- Participants whose glabellar line score was 2 (moderate) or higher of glabellar line score at maximum frown based on the investigator's judgment at screening and randomization.
- Participants who voluntarily gave a consent in writing to participate in the clinical study with full knowledge of details of the study after listening to them.
- Participants who can understand and comply with the procedures and visit schedules of the study.
Exclusion Criteria:
- Systemic neuromuscular junction disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, hereditary motor neuropathy, etc.)
- History of blepharoplegia or ptosis
- Prominent facial asymmetry
- Glabellar lines that are physically difficult to be improved, such as the case where the lines are not removed by hands
- Participants who have received any drugs that can act as a systemic muscle relaxant within 4 weeks prior to screening
- Participants who have received anticoagulants, anti-platelet agents, or systemic NSAIDs within 7 days prior to administration of investigational products (however, low-dose aspirin [325 mg/day or less] administered for antithrombotic purposes is acceptable)
- Participants who have participated in other clinical trials of a drug/medical device within 30 days from participating in this clinical study and have been administered/treated with the investigational product/medical device
- Participants deemed ineligible for this study for other reasons based on the investigator's judgment
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
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: Botulinum toxin type A (INI101)
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Single administration, Day 0, 20 units
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Aktiv komparator: Botulinum toxin type A (BOTOX®)
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Enkeltadministrasjon, Dag 0, 20 enheter
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Tidsramme: Baseline to week 4
|
Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) after 4 weeks of the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
|
Baseline to week 4
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Tidsramme: Baseline to week 8, 12, 16
|
Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
|
Baseline to week 8, 12, 16
|
|
Improvement rate of glabellar lines at rest according to the investigator's on-site assessment
Tidsramme: Baseline to week 4, 8, 12, 16
|
Investigator performed on-site assessment of the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
|
Baseline to week 4, 8, 12, 16
|
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Improvement rate of glabellar lines at maximum frown according to the independent assessor's photo assessment
Tidsramme: Baseline to week 4, 8, 12, 16
|
Independent assessor assessed the subject's glabellar lines 'At maximum frown' ' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.
|
Baseline to week 4, 8, 12, 16
|
|
Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment
Tidsramme: Baseline to week 4, 8, 12, 16
|
Independent assessor assessed the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.
|
Baseline to week 4, 8, 12, 16
|
|
Improvement rate of glabellar lines as assessed by the subject
Tidsramme: Baseline to week 4, 8, 12, 16
|
Subjects assessed their glabellar lines at each time point after the administration of the investigational product compared to baseline.
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Baseline to week 4, 8, 12, 16
|
|
Subject's satisfaction
Tidsramme: Baseline to week 4, 8, 12, 16
|
Subject's satisfaction score for the improvement of glabellar lines was investigated at each time point after the administration of the investigational product compared to before administration.
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Baseline to week 4, 8, 12, 16
|
Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
27. mai 2021
Primær fullføring (Faktiske)
30. januar 2022
Studiet fullført (Faktiske)
5. mars 2022
Datoer for studieregistrering
Først innsendt
26. mai 2026
Først innsendt som oppfylte QC-kriteriene
27. mai 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NI101-PLN-CO-002
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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