Proof of Concept Study to Isolate Cosmetic Improvement of Skin Using the Vitro Biopharma Secretome/Exosome Serum
2026년 5월 26일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
7
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Massachusetts
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Chestnut Hill, Massachusetts, 미국, 02467
- SkinCare Physicians
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention v Control
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The Vitro Biopharma Exosome Serum contains extracellular vesicles derived from umbilical cord MSCs
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants with Procedure-Related Adverse Events by Symptom and Severity
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference Between Intervention and Control Sides in Incidence of Anticipated Microneedling-Related Adverse Events
기간: 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
기간: 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)
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Skin Radiance on the Modified Griffiths 10-Point Scale by Blinded Evaluator
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 4월 17일
기본 완료 (실제)
2025년 1월 30일
연구 완료 (실제)
2025년 1월 30일
연구 등록 날짜
최초 제출
2026년 5월 13일
QC 기준을 충족하는 최초 제출
2026년 5월 26일
처음 게시됨 (실제)
2026년 6월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 26일
마지막으로 확인됨
2026년 5월 1일
추가 정보
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