Effektivitet og sikkerhet for rekombinant botulinumtoksin type A (Eveotox) for injeksjon for å behandle moderate til alvorlige glabellare linjer
En klinisk fase 3 -studie for å evaluere effektiviteten og sikkerheten til rekombinant botulinumtoksin type A for injeksjon (Eveotox) sammenlignet med en enkelt behandling av Botox og placebo, og gjentatt behandling av Eveotox i moderat til alvorlige glabellare linjer
This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of Eveotox in the treatment of moderate to severe glabellar lines. The study consists of Study Part 1 (randomized double-blind controlled study) and Part 2 (open-label study). Part I is a multicenter, randomized, double-blind, single-injection, active-controlled and placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of Eveotox in the treatment of moderate to severe glabellar lines; Part 2 is an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of Eveotox in the treatment of moderate to severe glabellar lines.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Danhua Lin
- Telefonnummer: 15811460241
- E-post: danhua.lin@jhm-biopharma.com
Studer Kontakt Backup
- Navn: Lei Wang
- E-post: lei.wang@jhm-biopharma.com
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina
- Rekruttering
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, Kina
- Rekruttering
- Peking University First Hospital
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Beijing, Beijing Municipality, Kina
- Rekruttering
- Peking University Third Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina
- Rekruttering
- The First Affiliated Hospital of Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, Kina
- Rekruttering
- The First Affiliated Hospital of Jinan University
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Guangzhou, Guangdong, Kina
- Rekruttering
- The Third Affiliated Hospital of Sun Yat-sen University
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Hebei
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Shijiazhuang, Hebei, Kina
- Rekruttering
- The First Hospital of Hebei Medical University
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Hunan
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Changsha, Hunan, Kina
- Rekruttering
- The Third Xiangya Hospital of Central South University
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Jiangsu
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Xuzhou, Jiangsu, Kina
- Rekruttering
- The Affiliated Hospital of Xuzhou Medical University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina
- Rekruttering
- Huashan Hospital, Fudan University
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Shanxi
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Xianyang, Shanxi, Kina
- Rekruttering
- Xianyang Hospital of Yan'an University
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Sichuan
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Chengdu, Sichuan, Kina
- Rekruttering
- West China Hospital, Sichuan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina
- Rekruttering
- Tianjin Medical University General Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina
- Rekruttering
- Zhejiang Provincial People's Hospital
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Hangzhou, Zhejiang, Kina
- Rekruttering
- Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Male or female subjects who are between 18 to 65 years of age
- Moderate or severe glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity scale
- Moderate or severe glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity scale
- Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial
Exclusion Criteria:
- Subjects who have a history of oversensitivity to the Botulinum Toxin A type or other components of the study drug
- Subjects who have implanted any permanent materials in the glabellar area or received semi-permanent fillers within the first 2 years of screening
- Subjects with active skin infections at the injection site or systemic skin disease, which the investigator judges can affect the evaluation of efficacy or safety
- Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Eveotox
Eveotox, 20 Units, divided into five injections into the glabellar area. Administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles. |
Rcombinant botulinum toxin type A for injection（Eveotox) |
|
Aktiv komparator: OnabotulinumtoxinA (Botox )
Botox,20 Units, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units). |
OnabotulinumtoxinA (Botox) |
|
Placebo komparator: Placebo
Placebo, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units) |
Placebo |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Primary Outcome Measure
Tidsramme: Within 4 weeks
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Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit relative to baseline, based on both the investigators´ and the subjects´ in-clinic assessments. |
Within 4 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Secondary Outcome Measure
Tidsramme: Within 52 weeks
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Incidence of serious adverse events and drug-related adverse events during the study. |
Within 52 weeks
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
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
- JHM03-CT301
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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