En undersøgelse af sikkerhed og effektivitet til evaluering af sårheling
Et randomiseret, dobbeltblindt, køretøjsstyret, dosis-eskaleringsstudie til evaluering af sikkerheden, farmakokinetik og farmakodynamik af intradermalt administreret AIV001 ved heling af incisionssår
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. A unique model was used to assess incisional scarring, safety and biomarker assessments. Women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. Up to 10 incisions were made on abdominal skn and treated as assigned. And data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. Exploratory efficacy measures were collected and pharmacokinetic profiles determined.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
California
-
Folsom, California, Forenede Stater, 95630
- Kaufman and Davis Plastic Surgery
-
San Diego, California, Forenede Stater, 92121
- Cosmetic Laser Dermatology
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Eligible for an abdominoplasty
- Nonsmoker
- Fitzpatrick I-IV
- Weight >45Kg
- BMI <= 35
Exclusion Criteria:
- Existing scars in study area, active infection
- Any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 0.033% versus Vehicle
One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle. |
Intradermal injection
Andre navne:
|
|
Eksperimentel: 0.1% versus Vehicle
One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle. |
Intradermal injection
Andre navne:
|
|
Eksperimentel: 0.3% versus Vehicle
One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle. |
Intradermal injection
Andre navne:
|
|
Eksperimentel: 1% versus Vehicle
One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle. |
Intradermal injection
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse events
Tidsramme: Day 1 through Day 49
|
Local and systemic adverse events |
Day 1 through Day 49
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable)
Tidsramme: Day 7 through 49
|
Evaluation of the healing of the wounds |
Day 7 through 49
|
|
Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)
Tidsramme: Day 7 through 49
|
Evaluation of the healing wounds |
Day 7 through 49
|
|
100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)
Tidsramme: Day 7 through 49
|
Evaluation of healing wounds |
Day 7 through 49
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: James Milbauer, MD, Novella Clinical
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AIV001-W01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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