A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery (SYNTROMICS)
A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery Through AI-Assisted In Vivo Imaging and Transcriptomics
Photodamaged skin increases the risk of skin cancer, highlighting the need for preventive treatments. Laser-assisted drug delivery (LADD) using ablative fractional lasers (AFL) enhances topical drug delivery and has proven safe and effective. Integrating non-invasive optical imaging techniques with transcriptomic gene expression profiling enables evaluation of the response of different skin layers to such interventions.
It is hypothesized that AFL-assisted delivery of biostimulators exerts synergistic regenerative effects on photodamaged skin, resulting in superior clinical, molecular, and morphological improvements, as well as enhanced epidermal and dermal remodeling, compared with either monotherapy alone. The study aims to provide an in-depth understanding of the individual and combined effects of AFL and biostimulators on the regeneration of photodamaged skin through clinical assessments, non-invasive imaging, and transcriptomic analysis.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Capital Region
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Copenhagen、Capital Region、デンマーク、2400
- Bispebjerg Hospital
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コンタクト：
- Aqella Rasul, MD
- 電話番号：004571590063
- メール：aqella.rasul.01@regionh.dk
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age ≥18 years
- Clinical signs of photodamage. Signs will include low-grade actinic keratoses (Olsen grade I-II), solar lentigines, telangiectasia, or other visible markers of chronic photodamage.
Exclusion Criteria:
- Active skin diseases in the treatment site
- Laser treatment, PLLA, or other treatments in the treatment area within the past 24 months
- Pregnancy or breastfeeding
- Contraindications to AFL or Sculptra
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：コントロール
治療なし
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実験的：Laser-assisted PLLA delivery
AFL treatment followed by immediate topical application of PLLA
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Treatment with AFL on the dorsal part of hand
他の名前：
Following AFL, PLLA will be applied to the same area
他の名前：
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アクティブコンパレータ：AFL treatment
Treatment with AFL alone
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Treatment with AFL on the dorsal part of hand
他の名前：
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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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Clinical efficacy
時間枠：Baseline to Week 36
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Change from baseline in the overall clinical appearance of photodamage in the treated area will be assessed using a 5-point Global Improvement Score (GIS) ranging from 0 to 4, where 0 indicates no improvement and 4 indicates >75 % improvement.
Assessments will be performed by the on-site investigator and independent blinded physicians based on standardized clinical photographs.
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Baseline to Week 36
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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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Transcriptomic response
時間枠：Baseline to Week 36
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Changes in gene expression profiles will be assessed by transcriptomic analysis of tape-strip samples collected before and after treatment and compared between intervention arms.
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Baseline to Week 36
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Safety of interventions
時間枠：Baseline to week 36
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Safety will be evaluated by the incidence, severity, and relationship to treatment of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study period. AEs and SAEs will be recorded continuously at each study visit and assessed by the investigator. |
Baseline to week 36
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Pain assessment
時間枠：Baseline to Week 36
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Pain associated with each intervention will be assessed using a patient-reported Numeric Rating Scale (NRS) ranging from 1 to 10, where 1 indicates minimal pain and 10 indicates the worst imaginable pain.
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Baseline to Week 36
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Patient-reported improvement
時間枠：From baseline to Week 36
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Perceived improvement will be assessed using a 5-point improvement scale ranging from 0 to 4, where 0 indicates no improvement and 4 indicates the greatest possible improvement.
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From baseline to Week 36
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Patient satisfaction
時間枠：Baseline to Week 36
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Patient satisfaction will be assessed using a 5-point satisfaction scale ranging from -2 to +2, where -2 indicates very dissatisfied, 0 indicates neutral, and +2 indicates very satisfied.
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Baseline to Week 36
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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
その他の研究ID番号
- 16-0302-103 (その他の識別子：De Videnskabsetiske Medicinske Komitéer)
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?
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
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