Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines? (toxin)
Effect of Sequential trenibotulinumtoxinE on the Duration of onabotulinumtoxinA Effect in Lateral Canthal Lines: An Exploratory, Randomized, Placebo-Controlled, Split-Face Pilot Study
This pilot study will look at whether trenibotulinumtoxinE can shorten or reverse the effect of onabotulinumtoxinA in people being treated for lateral canthal lines (also called crow's feet). OnabotulinumtoxinA is a commonly used treatment that relaxes the muscles around the eyes and smooths these lines, and its effect usually lasts about three to four months. Some people may want the effect to wear off sooner. This study will test whether giving trenibotulinumtoxinE after onabotulinumtoxinA changes how long the effect lasts.
Participants will receive onabotulinumtoxinA on both sides of the face. Using a split-face design, one side of each person's face will then be randomly assigned to receive trenibotulinumtoxinE and the other side will receive a placebo. This lets each person act as their own comparison. [Number] adults will take part, and they will be followed for [length of follow-up] to see how long the effect on each side of the face lasts. The main measure is [primary outcome, e.g., time until lateral canthal line severity returns to baseline on each side]. Safety and side effects will also be recorded.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Alain Michon, MD
- 電話番号：613-745-7546
- メール：alain.michon@projectskinmd.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Inclusion criteria Adults aged 18 to 65 years. Moderate to severe lateral canthal lines (crow's feet) at maximum smile on both sides, bilaterally symmetrical, as rated by the investigator on the Facial Wrinkle Scale (grade 2 or 3).
Good general health, based on medical history and physical examination. Willing to receive onabotulinumtoxinA in both lateral canthal areas, accept random assignment of trenibotulinumtoxinE or saline to each side, and attend all study visits and photography.
Women of childbearing potential agree to use effective contraception during the study.
Written informed consent.
Exclusion Criteria:
- Any botulinum toxin (any serotype, any site) in the previous 6 months. Known hypersensitivity to any botulinum toxin or to the excipients, or a history of resistance or immunization to botulinum toxin.
Neuromuscular disease (myasthenia gravis, Lambert-Eaton syndrome, ALS, motor neuropathy) or any condition affecting neuromuscular function.
Use of medications that potentiate botulinum toxin (such as aminoglycosides, curare-like agents) in the past 4 weeks.
Facial nerve palsy, eyelid or brow ptosis, marked facial asymmetry, or excessive dermatochalasis.
Deep dermal scarring, or inability to substantially lessen the lines by spreading the skin apart.
Previous surgery of the periorbital area (blepharoplasty, brow lift), or fillers, laser resurfacing, deep peels, or other cosmetic procedures in the periorbital area in the past 6 to 12 months.
Active infection or skin disease at the injection sites. Pregnancy, breastfeeding, or planned pregnancy during the study. Anticoagulant therapy or a bleeding disorder (increased risk of bruising). Participation in another clinical trial within 30 days. Any condition that, in the investigator's opinion, could put the participant at risk or confound the results.
研究計画
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：TrenibotulinumtoxinE Side
OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. One side of the face, chosen at random, then receives trenibotulinumtoxinE. The other side receives placebo (see Placebo Side arm). |
OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. One side of the face, chosen at random, then receives trenibotulinumtoxinE. The other side receives placebo (see Placebo Side arm). |
|
プラセボコンパレーター：Placebo Side
OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. The side of the face not assigned to trenibotulinumtoxinE receives placebo. |
OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. The side of the face not assigned to trenibotulinumtoxinE receives placebo. |
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 |
|---|---|---|
|
Duration of OnabotulinumtoxinA Effect on Lateral Canthal Lines
時間枠：From onabotulinumtoxinA injection through day 120.
|
Time in days from onabotulinumtoxinA injection until lateral canthal line severity at maximum smile returns to baseline (pre-treatment) severity, measured separately for each side of the face using [rating scale, e.g., the validated Facial Wrinkle Scale] by a blinded assessor. The duration will be compared between the side treated with trenibotulinumtoxinE and the side treated with placebo. |
From onabotulinumtoxinA injection through day 120.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Lateral Canthal Line Severity at Maximum Smile
時間枠：From day 0 to day 120.
|
Change from baseline in severity on each side of the face, rated by a blinded assessor using Allergan Facial Wrinkle Scale. Compared between the trenibotulinumtoxinE side and the placebo side. |
From day 0 to day 120.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PS01-treni
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data will not be shared. This pilot study includes only 4 participants, and the data include standardized facial photographs and detailed split-face assessments that cannot be adequately de-identified without a risk of re-identifying participants. Participants have not consented to public data sharing. Aggregate, de-identified results (individual-level descriptions without identifying information) will be reported in publications and in the ClinicalTrials.gov results section if applicable.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。