Evaluate the Efficacy and Safety of INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
1 juni 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
292
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Seoul, Sydkorea
- INIBIO Co., Ltd.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Enstaka administration, Dag 0, 20 enheter
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Tidsram: Baseline to week 8, 12, 16
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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
|
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Improvement rate of glabellar lines at rest according to the investigator's on-site assessment
Tidsram: 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
Tidsram: 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.
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Baseline to week 4, 8, 12, 16
|
|
Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment
Tidsram: 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
|
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Improvement rate of glabellar lines as assessed by the subject
Tidsram: 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
|
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Subject's satisfaction
Tidsram: 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.
|
Baseline to week 4, 8, 12, 16
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
27 maj 2021
Primärt slutförande (Faktisk)
30 januari 2022
Avslutad studie (Faktisk)
5 mars 2022
Studieregistreringsdatum
Först inskickad
26 maj 2026
Först inskickad som uppfyllde QC-kriterierna
27 maj 2026
Första postat (Faktisk)
2 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NI101-PLN-CO-002
Läkemedels- och apparatinformation, studiedokument
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Studerar en amerikansk FDA-reglerad produktprodukt
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