Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation
2020年10月15日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
49
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Newport Beach、California、アメリカ、92660
- Dr. George Taylor
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年～75年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
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他の名前：
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介入なし：Standard of care
No topical therapies for 24 hours post-radio-frequency treatment of the face
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
時間枠：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.
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24hr post treatment one
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Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
時間枠：72 hrs 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.
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72 hrs post treatment one
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Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
時間枠：24hr post treatment two
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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.
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24hr post treatment two
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Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
時間枠：72hr post treatment two
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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.
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72hr post treatment two
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Visual Analog Scale
時間枠：immediately following radio-frequency treatment
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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
時間枠：change in appearance of wrinkles from baseline and at end of study, average of 24 days
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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
時間枠：change in skin appearance between baseline and at end of study, average of 24 days
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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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Joseph L Reiz, BSc、Venus Concept Ltd.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年8月1日
一次修了 (実際)
2016年12月1日
研究の完了 (実際)
2017年2月27日
試験登録日
最初に提出
2016年8月31日
QC基準を満たした最初の提出物
2016年9月6日
最初の投稿 (見積もり)
2016年9月12日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月3日
QC基準を満たした最後の更新が送信されました
2020年10月15日
最終確認日
2020年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Topical combination therapyの臨床試験
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Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
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Universitätsklinikum Hamburg-Eppendorf完了