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

15 oktober 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

49

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Newport Beach, California, Verenigde Staten, 92660
        • Dr. George Taylor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Ander: Topical combination therapy
Andere namen:
  • SCR Complex
  • Bio Cel
Geen tussenkomst: Standard of care
No topical therapies for 24 hours post-radio-frequency treatment of the face

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Visual Analog Scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Venus Concept

Onderzoekers

  • Studie directeur: Joseph L Reiz, BSc, Venus Concept Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2016

Primaire voltooiing (Werkelijk)

1 december 2016

Studie voltooiing (Werkelijk)

27 februari 2017

Studieregistratiedata

Eerst ingediend

31 augustus 2016

Eerst ingediend dat voldeed aan de QC-criteria

6 september 2016

Eerst geplaatst (Schatting)

12 september 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2020

Laatste update ingediend die voldeed aan QC-criteria

15 oktober 2020

Laatst geverifieerd

1 oktober 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CS0116

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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