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Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation

15. oktober 2020 oppdatert av: Venus Concept

Clinical Evaluation of the Tolerability of Using a Post Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation Using the Venus Viva

The purpose of this study is to compare the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor (SCR Complex) and cytokines and a botanical lipid-based occlusive (Bio Cel) immediately following fractional radiofrequency treatment using the Venus Viva versus standard of care.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Randomized, open-label, multi-centre study to evaluate the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor and cytokines (SCR Complex™) and a botanical lipid based occlusive (Bio Cel™) following facial fractional RF treatments using the Venus Viva™ SR system. Each subject will receive 2 treatments separated by a 3-week interval. Subjects will complete a VAS and Tolerability Scale immediately following each treatment. Telephone follow-up calls by the site will ask the subject to respond to the Self-Report Adverse Event Questionnaire 24 and 72 hours after the first treatment and 24 hours after the second treatment. Subjects will complete a Home Tolerability Scale 24 and 72 hours after the first treatment and 24 hours after the second treatment. Subjects will return for the final FU visit and be asked to respond to the Self-Report Adverse Event Questionnaire and complete the Home Tolerability Scale for 72 hours. The investigator will also evaluate the subject's improvement using the GAIS at this visit.

Studietype

Intervensjonell

Registrering (Faktiske)

49

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Newport Beach, California, Forente stater, 92660
        • Dr. George Taylor

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Undergoing a dermatological procedure requiring ablation and resurfacing of the facial skin utilizing the Venus Viva™ SR system.
  • Women of child-bearing age are required to be using a reliable method of birth control prior to enrollment and throughout their participation in the study.
  • Able to tolerate the treatment as determined by a test spot application(s).

Exclusion Criteria:

  • Superficial metal or other implants in the treatment area
  • Tattoos, permanent makeup, scars or piercings in the treatment area.
  • Any active condition in the treatment area, such as sores, psoriasis, eczema and rash.
  • Any surgical procedure in the treatment area within the last three months or before complete healing.
  • Receiving therapies or medication that may interfere with the study treatment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Topical combination therapy
Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face
Annen: Topical combination therapy
Andre navn:
  • SCR Complex
  • Bio Cel
Ingen inngripen: Standard of care
No topical therapies for 24 hours post-radio-frequency treatment of the face

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
Tidsramme: 24hr post treatment one
Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
24hr post treatment one
Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
Tidsramme: 72 hrs post treatment one
Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
72 hrs post treatment one
Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
Tidsramme: 24hr post treatment two
Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
24hr post treatment two
Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
Tidsramme: 72hr post treatment two
Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
72hr post treatment two

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual Analog Scale
Tidsramme: immediately following radio-frequency treatment
10 cm Subject discomfort scale where 10 cm indicates 'Pain as bad as it can be' and 0 cm indicates there is no pain at all associated with the application of the treatment. Zero pain means a better outcome. Subjects were categorized as to having no pain (0 - 0.4cm), mild pain (0.5 - 4.4cm), moderate pain (4.5 - 7.4cm) and severe pain (7.5 - 10cm).
immediately following radio-frequency treatment
Fitzpatrick Wrinkle and Elastosis Scale
Tidsramme: change in appearance of wrinkles from baseline and at end of study, average of 24 days
Investigator assessment of improvement in wrinkles and elastosis where Class I indicates fine wrinkles, Class II indicates fine to moderate depth wrinkles with a moderate number of lines and Class III indicates fine to deep wrinkles, numerous lines with or without redundant skin folds with a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis ([indvidual papules with yellow translucency under direct lighting] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis. A lower class and a lower score means a better outcome. Subjects were divided into 3 categories - No change in FWES score, change in FWES score by one and non-evaluable.
change in appearance of wrinkles from baseline and at end of study, average of 24 days
Global Aesthetic Improvement Scale
Tidsramme: change in skin appearance between baseline and at end of study, average of 24 days
Investigator assessment of aesthetic improvement where 1 shows exceptional improvement, 2 shows very improved, 3 shows improvement, 4 shows unchanged and 5 indicates that the subject appearance has worsened. A low score means a better outome. Subjects were categorized to either GAIS improved or GAIS no change.
change in skin appearance between baseline and at end of study, average of 24 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Venus Concept

Etterforskere

  • Studieleder: Joseph L Reiz, BSc, Venus Concept Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2016

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

27. februar 2017

Datoer for studieregistrering

Først innsendt

31. august 2016

Først innsendt som oppfylte QC-kriteriene

6. september 2016

Først lagt ut (Anslag)

12. september 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CS0116

Plan for individuelle deltakerdata (IPD)

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NEI

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