THERAVEX® REGENERA Tissue Care Plus for Hair Regeneration and Follicular Microenvironment Modulation
Prospective Translational Preclinical and Clinical Investigation Evaluating the Regenerative Effects and Safety of THERAVEX® REGENERA Tissue Care Plus on Hair Follicular Regeneration, Extracellular Matrix Modulation, and Follicular Microenvironment Optimization Using Preclinical Murine Models, Hair Transplantation Regenerative Support Protocols, and Exploratory Dermapen-assisted Scalp Regenerative Therapy in Alopecic Patients.
調査の概要
詳細な説明
This clinical investigation was designed to evaluate the clinical performance and safety of THERAVEX® REGENERA Tissue Care Plus as a supportive regenerative therapy in hair restoration and scalp regenerative procedures. Hair loss disorders and follicular density reduction are commonly associated with alterations in the scalp microenvironment, postoperative tissue stress, and impaired regenerative conditions that may influence hair restoration outcomes and postoperative recovery.
THERAVEX® REGENERA Tissue Care Plus is a sterile bioactive mineral-ionic formulation intended for local supportive use during regenerative scalp procedures. The investigational approach focused on evaluating its use as an adjunctive supportive therapy during follicular graft preparation, postoperative scalp care, and regenerative scalp support protocols under standardized clinical conditions.
The investigation included adult participants undergoing autologous hair transplantation procedures as well as participants presenting with non-scarring alopecic conditions requiring regenerative scalp treatment approaches. The investigational device was evaluated in combination with routine clinical hair restoration procedures and supportive regenerative scalp protocols, including topical scalp application, follicular graft conditioning, Dermapen-assisted scalp procedures, and mesotherapy-assisted scalp support techniques.
Clinical follow-up assessments included standardized scalp evaluation, digital photographic documentation, postoperative tissue response assessment, follicular density observation, tolerability monitoring, and longitudinal regenerative scalp follow-up. Participants were monitored throughout the predefined observation period according to standardized clinical evaluation schedules.
The study was conducted to further investigate the feasibility, tolerability, and clinical applicability of extracellular microenvironment supportive approaches in regenerative scalp care and hair restoration procedures.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Barcelona、スペイン、08009
- Biointelligent Technology Syst
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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:
Adults aged 18 years or older Diagnosis of androgenetic alopecia Candidates for hair restoration procedures
Exclusion Criteria:
Active scalp infection or inflammatory scalp disease Cicatricial alopecia or severe scalp pathology Uncontrolled systemic disease or unstable medical condition Pregnancy or breastfeeding Immunosuppressive therapy hypersensitivity to any component of the investigational device
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：非ランダム化
- 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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アクティブコンパレータ：THERAVEX Regenerative Support
Sterile bioactive mineral-ionic regenerative solution used as supportive therapy during hair restoration and regenerative scalp procedures.
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Conventional follicular transplantation and postoperative scalp care performed according to routine clinical practice.
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アクティブコンパレータ：Standard Hair Restoration Care
Participants undergoing conventional hair restoration and postoperative scalp care procedures without THERAVEX® regenerative support.
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Conventional follicular transplantation and postoperative scalp care performed according to routine clinical practice.
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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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Follicular Density Assessment
時間枠：Baseline, 1 month, 3 months, 6 months, and 12 months
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Quantitative evaluation of changes in follicular density following regenerative scalp support procedures using standardized trichoscopic imaging and digital follicular counting.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Scalp Tissue Response Assessment
時間枠：Baseline, 1 month, 3 months, 6 months, and 12 months]
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Clinical evaluation of scalp tissue condition following regenerative scalp support procedures using standardized investigator-based assessment of tissue appearance, hydration, erythema, and overall scalp condition.
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Baseline, 1 month, 3 months, 6 months, and 12 months]
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- Son-Med-24-7-PD
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
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。
男性型脱毛症の臨床試験
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Erasmus Medical Center募集円形脱毛症（AA） | 円形脱毛症（AA） | 全身性脱毛症 (AT) | 全身性脱毛症 (AU) | Alopecia Totalis/Universalis | 円形脱毛症（および片麻痺）オランダ
Standard Hair Restoration Careの臨床試験
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