Proof of Concept Study to Isolate Cosmetic Improvement of Skin Using the Vitro Biopharma Secretome/Exosome Serum
2026年5月26日 更新者：Vitro Biopharma Inc.
Proof of Concept Split-Face Single-Blind Study to Assess the Cosmetic Appearance of Skin on Subjects Using the Vitro Biopharma Secretome/Exosome Serum
The purpose of this research is to characterize the safety, tolerability and efficacy of the investigational topical cosmetic product, the Vitro Biopharma Exosome Serum (Intervention), in impacting the cosmetic appearance of skin along with a microneedling procedure.
調査の概要
研究の種類
介入
入学 (実際)
7
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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Massachusetts
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Chestnut Hill、Massachusetts、アメリカ、02467
- SkinCare Physicians
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Male or female subjects over 30 years of age
- Non-smoker
- Fitzpatrick scale II-IV
- Mild to moderate skin wrinkles or fine lines around the eyes (periorbital) and/or radial cheek
- Subject agrees to maintain their weight (i.e. within 5%) by not making any major changes in diet of lifestyle during study
- Able to provide written informed consent, understand and willing to comply with study related procedures and follow-up
- Willing to undergo facial microneedling treatment
- Willing to sign photo release (For study purposes and potential publication)
Exclusion Criteria:
- Prior trauma, surgical procedure or invasive cosmetic procedure in the area of intended treatment
- Fat reduction/removal procedure in or around the area of intended treatment up to 1 year prior to enrollment
- Cosmetic injections into the area of intended treatment including botulinum toxin injections up to 6 months prior or filler injections up to 1 year prior to enrollment
- Ablative or non-ablative dermal resurfacing procedures within 6 months of screening
- Skin tightening procedures on the face within the past 3 months
- Currently using prescription facial wrinkle therapies
- History of bleeding disorder, or is taking any medication that may increase risk of bruising
- Dermatological conditions in the location of the treatment sites that may interfere with treatment
- Subject has an active infection
- Subject has a known metal allergy
- Pre-existing scars, tattoos, birthmarks or other physical features in the area of treatment that may confound the outcome in the investigators opinion
- Active implanted device such as pacemaker, defibrillator, drug delivery system
- Pregnant or intending to become pregnant
- Lactating or has been lactating in the last 6 months
- History of coagulopathy, or taking anticoagulants
- Taking daily oral aspirin
- Immunocompromised or immunosuppressed
- Active, chronic or recurrent infection
- Hypersensitivity to analgesic agents
- History of keloid scar formation
- Chronic disease such as diabetes, hepatitis, etc.
- Oral corticosteroids or topical steroids in the treatment area
- Prescription or over the counter (OTC) medication or cosmetics applied to treatment area containing: retinoids, glycol acid, salicylic acid or any other remedies that might affect the healing process.
- Co-morbid condition that could limit ability to participate in the study or comply with follow-up requirements
- Untreated drug and/or alcohol abuse
- Unable or unwilling to comply with the study requirements
- Enrolled in another clinical study or taking any unknown or not Food and Drug Administration (FDA) approved medications
- Any other condition or presentation that in the opinion of the Investigator might exclude the subject
- Intends to begin any new skin medications in the treatment areas
- Intends to change their daily skincare routine before or during the study
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：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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：Intervention v Control
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The Vitro Biopharma Exosome Serum contains extracellular vesicles derived from umbilical cord MSCs
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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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Number of Participants with Procedure-Related Adverse Events by Symptom and Severity
時間枠：Procedure Day through Day 90 follow-up (assessments at 1 hour, Day 1, 7, 21, 45, 46, 52, 66, and 90)
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Adverse events related to the procedure (microneedling with or without Vitro Biopharma Exosome Serum) will be assessed at each in-person follow-up visit using the Clinical Safety Assessment (Protocol Appendix D).
Physician-assessed events include erythema, edema, and scabbing/peeling/dry skin.
Subject-reported events include pain, pruritis, paresthesia, and discomfort.
Each event will be recorded as present or absent with severity graded as Mild, Moderate, or Severe.
Number of participants with each event by severity grade will be reported for each treatment side.
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Procedure Day through Day 90 follow-up (assessments at 1 hour, Day 1, 7, 21, 45, 46, 52, 66, and 90)
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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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Difference Between Intervention and Control Sides in Incidence of Anticipated Microneedling-Related Adverse Events
時間枠：Post-procedure Days 1, 7, 21, and 45 on each treatment side (study Days 1, 7, 21, 45 for control; study Days 46, 52, 66, 90 for intervention)
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For each anticipated microneedling-related event (erythema, edema, scabbing/peeling/dry skin, pain, pruritis, paresthesia, discomfort) defined in Protocol Appendix D, the number of participants reporting the event on the intervention (Exosome Serum) side will be compared to the number reporting the event on the control (no Exosome Serum) side at matched post-procedure time points.
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Post-procedure Days 1, 7, 21, and 45 on each treatment side (study Days 1, 7, 21, 45 for control; study Days 46, 52, 66, 90 for intervention)
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Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Score by Blinded Evaluator
時間枠：Day 45 and Day 90 follow-up (live assessment); post-Day 90 image-based assessment
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Aesthetic improvement of each treatment area relative to baseline images will be rated by a blinded evaluator using the 5-point GAIS (1 = Exceptional Improvement, 2 = Very Improved, 3 = Improved, 4 = Unaltered, 5 = Worsened).
Mean GAIS score will be reported per treatment side at each assessment, and the difference between intervention and control sides will be reported.
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Day 45 and Day 90 follow-up (live assessment); post-Day 90 image-based assessment
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Change from Baseline in Transepidermal Water Loss (TEWL)
時間枠：Time Frame: Pre-Treatment (baseline) and follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
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TEWL will be measured at each treatment area using a topical probe with temperature and relative humidity sensors, reported in g/m²/h.
Mean change from baseline at each post-procedure time point and the difference between intervention and control sides will be reported.
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Time Frame: Pre-Treatment (baseline) and follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
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Change from Baseline in Subject-Reported Clinical Global Impression-Improvement (CGI-I) Score
時間枠：Follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
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At each follow-up visit, subjects will rate overall appearance of each treatment area compared to before the procedure using the CGI-I (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse), per Protocol Appendix F. Mean score per side at each time point and the between-side difference will be reported.
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Follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Skin Radiance on the Modified Griffiths 10-Point Scale by Blinded Evaluator
時間枠：Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Skin radiance improvement on each treatment area will be rated by a blinded evaluator using the Modified Griffiths 10-point scale (0 = No Improvement; I to III = Mild; IV to VI = Moderate; VII to IX = Best Improvement), per Protocol Appendix G. Mean score per side and between-side difference will be reported.
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Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Change from Baseline in Skin Tone Evenness on the Modified Griffiths 10-Point Scale by Blinded Evaluator
時間枠：Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Skin tone evenness on each treatment area will be rated by a blinded evaluator using the Modified Griffiths 10-point scale (None (0); Mild (I to III); Moderate (IV to VI); Severe (VII to IX) unevenness of red/brown patches or spots), per Protocol Appendix G. Mean score per side and between-side difference will be reported.
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Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Change from Baseline in Surface Roughness on the Allergan Skin Roughness Scale by Blinded Evaluator
時間枠：Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Visual surface roughness on each treatment area will be rated by a blinded evaluator using the Allergan Skin Roughness Scale (0 = None, 1 = Minimal, 2 = Moderate, 3 = Severe, 4 = Extreme), per Protocol Appendix G. Mean score per side and between-side difference will be reported.
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Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Change from Baseline in Cheek and Midface Wrinkle Severity on the Allergan Fine Lines Scale by Blinded Evaluator
時間枠：Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Cheek and midface fine line severity on each treatment area will be rated by a blinded evaluator using the Allergan Fine Lines Scale (0 = None, 1 = Minimal, 2 = Moderate, 3 = Severe, 4 = Diffuse), per Protocol Appendix G. Mean score per side and between-side difference will be reported.
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Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Change from Baseline in Periorbital Wrinkle Severity at Rest on the Merz Scale by Blinded Evaluator
時間枠：Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Periorbital wrinkle severity at rest on each treatment area will be rated by a blinded evaluator using the Merz Scale (0 = No Wrinkles, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very Severe), per Protocol Appendix G. Mean score per side and between-side difference will be reported.
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Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Change from Baseline in Dynamic Periorbital Wrinkle Severity (Smiling) on the Merz Scale by Blinded Evaluator
時間枠：Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Periorbital wrinkle severity while smiling on each treatment area will be rated by a blinded evaluator using the Merz Scale (0 = No Wrinkles, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very Severe), per Protocol Appendix G. Mean score per side and between-side difference will be reported.
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Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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Change from Baseline in Skin Viscoelasticity by Cutometer Measurement
時間枠：Pre-Treatment (baseline) and follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
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Mechanical/viscoelastic properties of the skin will be measured at each treatment area using a Cutometer, reported as the R2 (gross elasticity) parameter.
Mean change from baseline at each post-procedure time point and the difference between intervention and control sides will be reported.
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Pre-Treatment (baseline) and follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
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Change from Baseline in Subject Satisfaction with Facial Skin Attributes (5-Point Likert Scale)
時間枠：Baseline (pre-procedure) and Day 90 follow-up
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Subjects will rate satisfaction with five facial skin attributes (presence of wrinkles under the eyes, presence of wrinkles on the cheeks, smoothness, radiance/brightness, and tone evenness) on a 5-point Likert scale (1 = Very Satisfied, 2 = Somewhat Satisfied, 3 = Neither Satisfied nor Dissatisfied, 4 = Somewhat Dissatisfied, 5 = Very Dissatisfied) at baseline (Protocol Appendix E) and at final follow-up (Protocol Appendix H) for each treatment side.
Mean change per attribute per side and between-side difference will be reported.
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Baseline (pre-procedure) and Day 90 follow-up
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Number of microRNAs (miRNAs) Demonstrating Consistent Directional Change in Expression on the Intervention Side Compared to the Control Side by NanoString miRNA Profiling
時間枠：Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90)
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Punch biopsies of periauricular skin obtained pre-procedure (baseline), post-control side procedure, and post-intervention side procedure will undergo RNA extraction and miRNA expression profiling by NanoString miRNA technology at a blinded contract laboratory.
Raw Reporter Code Count (RCC) files will be background-normalized using negative-control probe thresholds, and low-expressing miRNAs will be removed.
Percent-change from baseline will be calculated separately for the control and intervention sides.
A tiered filtering algorithm will identify miRNAs meeting cross-subject directional consistency and a magnitude threshold on the net-effect calculation.
The total number of miRNAs meeting these pre-specified criteria will be the reported endpoint.
Descriptive breakdowns of the identified miRNAs will be reported in tables.
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Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90)
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Histologic Assessment of Elastic Fiber Architecture in Skin Biopsy (Van Gieson Stain) by Blinded Dermatopathologist
時間枠：Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90)
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Punch biopsies of periauricular skin will be obtained pre-procedure (baseline), 30 to 45 days post-control side procedure, and 30 to 45 days post-intervention side procedure.
Sections will be stained with Van Gieson and evaluated by a board-certified dermatopathologist blinded to treatment assignment.
Elastic fiber architecture in the papillary dermis on the intervention side will be categorized relative to the matched control side as increased, unchanged, or decreased.
The number of subjects in each directional category will be reported.
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Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90)
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Histologic Assessment of Collagen Fiber Density and Organization in Skin Biopsy (Masson's Trichrome Stain) by Blinded Dermatopathologist
時間枠：Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90)
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Punch biopsies of periauricular skin will be obtained pre-procedure (baseline), 30 to 45 days post-control side procedure, and 30 to 45 days post-intervention side procedure.
Sections will be stained with Masson's Trichrome and evaluated by a board-certified dermatopathologist blinded to treatment assignment.
Collagen fiber density and organization on the intervention side will be categorized relative to the matched control side as increased, unchanged, or decreased.
The number of subjects in each directional category will be reported.
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Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90)
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Histologic Assessment of Vascular Density in Skin Biopsy (H&E Stain) by Blinded Dermatopathologist
時間枠：Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90)
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Punch biopsies of periauricular skin will be obtained pre-procedure (baseline), 30 to 45 days post-control side procedure, and 30 to 45 days post-intervention side procedure.
Sections will be stained with hematoxylin and eosin (H&E) and evaluated by a board-certified dermatopathologist blinded to treatment assignment.
Vascular density on the intervention side will be categorized relative to the matched control side as increased, unchanged, or decreased.
The number of subjects in each directional category will be reported.
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Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90)
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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
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 (実際)
2024年4月17日
一次修了 (実際)
2025年1月30日
研究の完了 (実際)
2025年1月30日
試験登録日
最初に提出
2026年5月13日
QC基準を満たした最初の提出物
2026年5月26日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月2日
QC基準を満たした最後の更新が送信されました
2026年5月26日
最終確認日
2026年5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。