Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases
9. februar 2012 opdateret af: Castle Creek Biosciences, LLC.
The purpose of this study is to evaluate the safety profile and the treatment effect of autologous human fibroblasts and placebo when administered to facial wrinkles and creases
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
California
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Beverly Hills, California, Forenede Stater, 90210
- Rhonda Rand, M.D., Inc.
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Santa Monica, California, Forenede Stater, 90404
- The Laser Institute for Dermatology
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Florida
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Orlando, Florida, Forenede Stater, 32804
- Winter Park and Orlando Plastic Surgery
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Massachusetts
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Wellesley, Massachusetts, Forenede Stater, 02481
- Dermatology Partners
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28207
- Dermatology, Laser and Vein Specialists of the Carolinas
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female, at least 18 years of age
- High Investigator wrinkle severity assessment score
- Subject assessment of dissatisfaction of facial appearance
- Provide written informed consent and comply with the study requirements
- Negative pregnancy test at screening visit
- Healthy, non-scarred skin for biopsy
Exclusion Criteria:
- Low Investigator wrinkle severity assessment score
- Subject assessment of satisfaction of facial appearance
- Physical attributes which prevent the assessment or treatment of the facial wrinkles
- Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical trial
- Previous treatment with Isolagen Therapy
- History of active autoimmune disease or organ transplantation
- Diagnosis of cancer, receiving active treatment
- History of pigmentary disorders which can affect the face
- Active or chronic skin disease
- Known genetic disorders affecting fibroblasts or collagen
- Active systemic infection
- Requires chronic antibiotic or steroidal therapy
- Use of certain cosmetic treatments & procedures
- Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
- Pregnant or lactating women or women trying to become pregnant
- Known allergic reaction to components of study treatment and/or study injection procedure
- Excessive exposure to sun or sunburn in the post-auricular area
- Subject has any disorder that may prevent compliance
- Subject who is part of the study staff, a family member or friend
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Aktiv
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment
Tidsramme: Baseline (prior to first treatment) compared to 6 months post last treatment
|
Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face.
A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best.
|
Baseline (prior to first treatment) compared to 6 months post last treatment
|
|
Independent Panel Global Improvement Assessment Compared to Baseline
Tidsramme: Baseline (prior to treatment) compared to 6 months post last treatment
|
An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment.
The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best.
|
Baseline (prior to treatment) compared to 6 months post last treatment
|
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
1. marts 2007
Primær færdiggørelse (Faktiske)
1. juni 2008
Studieafslutning (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først indsendt
3. april 2008
Først indsendt, der opfyldte QC-kriterier
3. april 2008
Først opslået (Skøn)
9. april 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. marts 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. februar 2012
Sidst verificeret
1. februar 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IT-R-007
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .