Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation
15 octobre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
49
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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California
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Newport Beach, California, États-Unis, 92660
- Dr. George Taylor
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
Autres noms:
|
|
Aucune intervention: Standard of care
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
Délai: 24hr post treatment one
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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
|
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Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
Délai: 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
|
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Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
Délai: 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
|
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Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual Analog Scale
Délai: 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).
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immediately following radio-frequency treatment
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Fitzpatrick Wrinkle and Elastosis Scale
Délai: 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.
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change in appearance of wrinkles from baseline and at end of study, average of 24 days
|
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Global Aesthetic Improvement Scale
Délai: 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.
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change in skin appearance between baseline and at end of study, average of 24 days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Joseph L Reiz, BSc, Venus Concept Ltd.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2016
Achèvement primaire (Réel)
1 décembre 2016
Achèvement de l'étude (Réel)
27 février 2017
Dates d'inscription aux études
Première soumission
31 août 2016
Première soumission répondant aux critères de contrôle qualité
6 septembre 2016
Première publication (Estimation)
12 septembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 novembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 octobre 2020
Dernière vérification
1 octobre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CS0116
Plan pour les données individuelles des participants (IPD)
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NON
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