- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04996810
The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines
8. august 2021 opdateret af: Protox Inc.
A Randomized, Double-blinded, Active Comparator, Single-dose, Phase I/II Trial to Evaluate the Safety and Efficacy of Treatment With PROTOXIN as Compared to BOTOX® in Adult Subjects Who Need Improvement of Moderate or Severe Glabellar Lines
This study will be conducted in Phase I/II clinical trials.
In Phase I, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL
each) in five sites of the glabellar lines.
Safety is assessed after 12 weeks.
In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL
each)in five sites of the glabellar lines.
Thereafter, efficacy and safety are assessed by comparing with BOTOX®.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Seoul, Korea, Republikken
- Chung-Ang University Hospital
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Seoul, Korea, Republikken
- Nowon Eulji Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Men and women aged between 19 to 65 years old
- Subjects attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown
- Fertile women who have properly agreed to contraception during the clinical trial period
- Subjects who voluntarily sign the informed consent
Exclusion Criteria:
- Subjects who answered 'Yes' any of the C-SSRS questions (only Phase I)
- Subjects with the general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome)
- Subjects who suffer from muscle weakness or paralysis in the forehead area
- Subjects with infection, skin disorders, or scars at the glabellar region.
- Subjects with noticeable facial asymmetry
- Subjects with allergy or hypersensitivity to the botulinum toxin or their components
- Subjects who have taken Anti-Coagulant, Anti-Platelet agent, Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
- Subjects who were injected facial with botulinum toxin within the past 6 months or whose dose exceeds 200 U for the whole body
- Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in the glabellar region
- Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks of the screening date.
- A history of drug or alcohol abuse
- Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception
- Subjects who are not eligible for this study based on the judgment of an investigator
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: PROTOXIN (Phase I/II)
PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL,
Total 20U/0.5mL).
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Botulinumtoksin Type A
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Aktiv komparator: Botox® (Phase II)
Botox® will be injected to 5 glabellar lines (Each 4U/0.1mL,
Total 20U/0.5mL).
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Botulinumtoksin Type A
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
Tidsramme: 12 weeks after the injection
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12 weeks after the injection
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Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
Tidsramme: 4 weeks after the injection
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4 weeks after the injection
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
Tidsramme: 4, 8, 12 weeks after the injection
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4, 8, 12 weeks after the injection
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Glabellar line improvement rate confirmed by subject' satisfaction assessment (Phase II)
Tidsramme: 4, 8, 12 weeks after the injection
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4, 8, 12 weeks after the injection
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Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)
Tidsramme: 12 weeks after the injection
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12 weeks after the injection
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. december 2020
Primær færdiggørelse (Faktiske)
2. april 2021
Studieafslutning (Faktiske)
26. maj 2021
Datoer for studieregistrering
Først indsendt
2. august 2021
Først indsendt, der opfyldte QC-kriterier
2. august 2021
Først opslået (Faktiske)
9. august 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PT_BTA_P1_20
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med PROTOXIN
-
Protox Inc.Ikke rekrutterer endnu
-
Protox Inc.AfsluttetGlabellar pandelinjerKorea, Republikken