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Phase 2 Evaluation of Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) Injection for the Treatment of Infraorbital Hollowing

27. října 2026 aktualizováno: Lynch Regenerative Medicine

A Multicenter, Phase 2 Randomized, Dose-Ranging and Pharmacokinetic Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) Injection for the Treatment of Infraorbital Hollowing

The goal of this Phase 2 clinical trial is to evaluate the safety, tolerability, and preliminary effectiveness of recombinant human platelet-derived growth factor-BB (rhPDGF-BB) injections for the treatment of moderate to severe infraorbital hollowing (under-eye hollows) in adults aged 21 to 65 years. The study is intended to evaluate the:

  • Safety and tolerability of rhPDGF-BB following injections in the infraorbital area
  • Preliminary efficacy (responder rate) of rhPDGF-BB compared with placebo
  • Effect of different doses of rhPDGF-BB compared with placebo with respect to treatment response and durability
  • Pharmacokinetic profile following injection of rhPDGF-BB in the infraorbital region
  • Immunogenicity profile following injection of rhPDGF-BB in the infraorbital region

This study will compare two doses of rhPDGF-BB (37.5 µg and 75 µg per infraorbital region) with placebo (normal saline) to evaluate safety and preliminary efficacy of rhPDGF-BB for improving infraorbital hollowing.

Participants will:

  • Receive injections of rhPDGF-BB or placebo in the infraorbital area.
  • Attend follow-up visits for safety and assessment of changes in infraorbital hollowing.
  • Undergo clinical grading and standardized facial imaging and complete questionnaires about treatment outcomes and satisfaction.
  • Provide blood samples for assessment of drug exposure and immune response to rhPDGF-BB.
  • Be evaluated for possible retreatment at Week 8 according to the study protocol and followed for up to 24 weeks after their final treatment.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

Infraorbital hollowing is characterized by a visible depression of the lower eyelid-cheek junction that may contribute to a tired or aged appearance. Recombinant human platelet-derived growth factor-BB (rhPDGF-BB) is being investigated as an injectable biologic treatment for infraorbital hollowing. This Phase 2 study is intended to characterize the safety and tolerability of rhPDGF-BB, obtain preliminary estimates of treatment effect, evaluate dose-response relationships, and generate information to support dose and endpoint selection for subsequent clinical development. This is a prospective, multicenter, randomized, evaluator-blinded, placebo-controlled, parallel-group, dose-ranging study. Approximately 75 participants will be randomized in a 1:1:1 ratio. Randomization will be stratified by study site and baseline severity of infraorbital hollowing. Subjects, outcome assessors, and image analysts will remain blinded to treatment assignment; designated personnel responsible for study intervention preparation and administration may be unblinded. An initial sentinel cohort will be enrolled and dosed sequentially in a staggered manner before full cohort enrollment. The sentinel phase is intended to characterize initial safety and tolerability, evaluate the feasibility of study procedures, and support Data and Safety Monitoring Board review before progression to broader enrollment. It is not intended to provide a definitive assessment of efficacy. The study will characterize treatment response using clinician-reported assessments, patient-reported outcomes, and standardized imaging. Three-dimensional and spectral imaging will provide quantitative measures of changes in infraorbital volume and skin characteristics. Pharmacokinetic assessments in a subset of participants (n=12) will characterize systemic exposure, if measurable, following local administration, and immunogenicity assessments will evaluate the development of anti-drug and neutralizing antibodies. Analyses will characterize safety and tolerability, estimate responder rates and treatment effects, examine dose-response relationships, assess the variability and responsiveness of clinical and patient-reported outcome measures, and evaluate durability of response. These data are intended to inform dose selection, endpoint strategy, and design assumptions for subsequent clinical development.

Typ studie

Intervenční

Zápis (Odhadovaný)

75

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • California
      • Newport Beach, California, Spojené státy, 92663
        • Steve Yoelin MD and Associates
        • Vrchní vyšetřovatel:
          • Steve Yoelin, MD
        • Kontakt:
      • Santa Monica, California, Spojené státy, 90404
        • Ava T. Shamban M.D., INC
        • Kontakt:
          • Tamar Melkonian
          • Telefonní číslo: 128 310-828-2282
          • E-mail: tamar@avamd.com
        • Vrchní vyšetřovatel:
          • Ava Shamban, MD
    • Illinois
      • Chicago, Illinois, Spojené státy, 60657
        • Fulcrum Aesthetics and Surgery
        • Vrchní vyšetřovatel:
          • David Hill, MD
        • Kontakt:
    • Maryland
      • Rockville, Maryland, Spojené státy, 20850
        • Aesthetic & Dermatology Center
        • Vrchní vyšetřovatel:
          • Lawrence Green, MD
        • Kontakt:
    • Michigan
      • Birmingham, Michigan, Spojené státy, 33131
        • Cosmetic Skin & Laser Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Charles Boyd, MD
    • Texas
      • Dallas, Texas, Spojené státy, 75231
        • Dallas Plastic Surgery Institute
        • Vrchní vyšetřovatel:
          • Rod Rohrich, MD
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

21 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Adults 21 to 65 years of age.
  • Moderate to severe infraorbital hollowing, defined as a Canfield Infraorbital Hollow Severity Scale (CIOHS) score ≥3; mild orbital fat ptosis is permitted if, in the investigator's judgment, the condition is amenable to treatment.
  • Fitzpatrick skin type I-VI.
  • Willing and able to comply with study visits and photography requirements and provide written informed consent.
  • Willing to refrain from other aesthetic treatments in the infraorbital region for the duration of the study.
  • Women of childbearing potential must have a negative pregnancy test at screening and agree to use a highly effective method of contraception from screening through 24 weeks after the final treatment. Acceptable methods include methods with a failure rate of <1% per year when used consistently and correctly (e.g., hormonal contraception, intrauterine device/system, bilateral tubal occlusion, or sexual abstinence consistent with the participant's lifestyle). Women of childbearing potential must not be pregnant or breastfeeding.

Exclusion Criteria:

  • Prior or planned during the study period dermal fillers, fat grafting, other injectable treatments, or aesthetic procedures in the infraorbital region.
  • Significant orbital fat herniation, skin laxity, or anatomical features that may confound assessment of infraorbital hollowing.
  • Prior surgical procedures in the infraorbital or periorbital region (e.g., blepharoplasty).
  • Lower-lid surgery (blepharoplasty) within 12 months or unresolved sequelae.
  • Active dermatologic disease, inflammation, or infection in the treatment area.
  • Autoimmune or connective tissue disease, immunosuppression, or other uncontrolled systemic disease (e.g., diabetes) judged to increase risk, affect healing, or otherwise affect study outcomes.
  • Known hypersensitivity to study product components or to local anesthetics used per protocol, including allergy to yeast-derived products.
  • History of abnormal wound healing (e.g., keloids or hypertrophic scarring).
  • Currently pregnant or breastfeeding or planning to become pregnant during the study.
  • Clinically significant ophthalmologic conditions that may confound safety assessments, including but not limited to visual acuity not corrected to at least 20/40, active glaucoma, severe dry eye disease, diabetic retinopathy, history of ocular surgery within 12 months, retinal or vascular ocular disease, or active ocular infection or inflammation.
  • Any medical history, condition, or prior procedure affecting the anatomy, appearance, or function of the infraorbital area, periorbital structures, orbital contents, nose, or mid-face that, in the investigator's judgment, would confound assessment of study treatment safety or efficacy or pose increased procedural risk. This includes, but is not limited to, prior orbital trauma or fracture, prior orbital or periorbital surgery, active or recurrent periorbital infections or inflammatory dermatoses, systemic anticoagulation or bleeding disorders, and active autoimmune or connective tissue diseases.
  • Concurrent use of prescription or nonprescription products with known or suspected growth-factor-mediated effects within protocol-defined washout periods that may confound efficacy assessment.
  • Use of anticoagulants, antiplatelet agents, or medications that may increase bleeding risk, unless stable and medically appropriate.
  • Participation in another clinical trial within the protocol-defined period before screening.
  • Known, untreated malignant neoplasm(s) at the treatment site(s) or currently undergoing radiation therapy or chemotherapy.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Low-Dose rhPDGF-BB (37.5 µg) per infraobital region

Participants randomized to this arm will receive recombinant human platelet-derived growth factor-BB (rhPDGF-BB) injection at a dose of 37.5 µg per infraorbital region. Participants may receive a protocol-permitted repeat treatment at Week 8 based on predefined retreatment criteria.
Biologický: RhPDGF-BB

Recombinant human platelet-derived growth factor-BB (rhPDGF-BB; becaplermin) is administered by subcutaneous injection into each infraorbital region. Participants assigned to active treatment receive either 37.5 µg or 75 µg of rhPDGF-BB per infraorbital region in a standardized injection volume of 0.75 mL. Participants meeting protocol-defined criteria may receive an optional repeat treatment at Week 8 using their originally assigned treatment.
Experimentální: High-Dose rhPDGF-BB (75 µg) per infraobital region

Participants randomized to this arm will receive recombinant human platelet-derived growth factor-BB (rhPDGF-BB) injection at a dose of 75 µg per infraorbital region. Participants may receive a protocol-permitted repeat treatment at Week 8 based on predefined retreatment criteria.
Biologický: RhPDGF-BB

Recombinant human platelet-derived growth factor-BB (rhPDGF-BB; becaplermin) is administered by subcutaneous injection into each infraorbital region. Participants assigned to active treatment receive either 37.5 µg or 75 µg of rhPDGF-BB per infraorbital region in a standardized injection volume of 0.75 mL. Participants meeting protocol-defined criteria may receive an optional repeat treatment at Week 8 using their originally assigned treatment.
Komparátor placeba: Placebo (Normal Saline)

Participants randomized to this arm will receive normal saline placebo injection in the infraorbital region. Participants may receive a protocol-permitted repeat treatment at Week 8 based on predefined retreatment criteria.
Lék: Normal Saline

Sterile normal 0.9% sodium chloride is administered as placebo by injection into each infraorbital region using the same administration approach as the investigational treatment. A volume of 0.75 mL is administered per infraorbital region. Participants meeting protocol-defined criteria may receive an optional repeat treatment at Week 8 using their originally assigned treatment.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence, Severity, and Relationship of Treatment-Emergent Adverse Events (TEAEs)
Časové okno: From first study injection through 24 weeks after the final treatment (up to Week 32 for participants receiving retreatment at Week 8)

Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and injection-site reactions. Adverse events will be coded using MedDRA, graded for severity, assessed for relationship to study treatment, and followed to resolution or stabilization. Safety assessments include local injection-site reactions, systemic adverse events, serious adverse events, and protocol-defined adverse events of special interest.
From first study injection through 24 weeks after the final treatment (up to Week 32 for participants receiving retreatment at Week 8)
Proportion of Participants With ≥1-Grade Improvement on the Canfield Infraorbital Hollow Severity Scale (CIOHS)
Časové okno: 12 weeks after final treatment (Week 12 after initial treatment or Week 20 for participants retreated at Week 8)

Proportion of participants classified as responders, defined as achieving a ≥1-grade improvement from baseline on the Canfield Infraorbital Hollow Severity Scale (CIOHS) 12 weeks after the final treatment, as assessed by a blinded evaluator. The CIOHS is a 4-point photonumeric scale ranging from 1 (none) to 4 (severe), with lower scores indicating less severe infraorbital hollowing.
12 weeks after final treatment (Week 12 after initial treatment or Week 20 for participants retreated at Week 8)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Responder rate (Proportion of Participants With ≥2-Grade Improvement on the Canfield Infraorbital Hollow Severity Scale (CIOHS)) 12 weeks after final treatment
Časové okno: 12 weeks after final treatment (Week 12 for participants receiving a single treatment; Week 20 for participants retreated at Week 8)

Proportion of participants achieving a ≥2-grade improvement from baseline on the Canfield Infraorbital Hollow Severity Scale (CIOHS), as assessed by a blinded evaluator. The CIOHS is a 4-point photonumeric scale ranging from 1 (none) to 4 (severe), with lower scores indicating less severe infraorbital hollowing.
12 weeks after final treatment (Week 12 for participants receiving a single treatment; Week 20 for participants retreated at Week 8)
Time Course and Durability of Change From Baseline in Canfield Infraorbital Hollow Severity Scale (CIOHS) Score
Časové okno: Baseline through 24 weeks after final treatment (up to Week 32)

Change from baseline in CIOHS score at all post-treatment assessments. CIOHS is a 4-point photonumeric scale ranging from 1 (none) to 4 (severe); a decrease from baseline indicates improvement in infraorbital hollowing.
Baseline through 24 weeks after final treatment (up to Week 32)
Investigator-Assessed Global Aesthetic Improvement Scale (GAIS)
Časové okno: Through 24 weeks after final treatment (up to Week 32)

Global aesthetic improvement following treatment as assessed by the investigator using the GAIS relative to baseline. GAIS is a 5-point scale ranging from "worse" to "very much improved" evaluating overall aesthetic improvement. Relative improvement on the GAIS ("much improved" and "very much improved") will be used in support of analysis of clinical meaningfulness for other outcome measures.
Through 24 weeks after final treatment (up to Week 32)
Participant-Assessed Global Aesthetic Improvement Scale (GAIS)
Časové okno: Through 24 weeks after final treatment (up to Week 32)

Global aesthetic improvement following treatment as assessed by the participant using the GAIS relative to baseline. GAIS is a 5-point scale ranging from "worse" to "very much improved" evaluating overall aesthetic improvement. Relative improvement on the GAIS ("much improved" and "very much improved") will be used in support of analysis of clinical meaningfulness for other outcome measures.
Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Recovery Early Symptoms Scores
Časové okno: Baseline through 14 days after each treatment

Change from baseline in selected FACE-Q Recovery Early Symptoms patient-reported outcome scores evaluating early symptoms related to the treatment procedure according to their respective scoring algorithms and the change from baseline. Higher scores in the FACE-Q® Recovery Early Symptoms outcome are the result of increased symptom severity.
Baseline through 14 days after each treatment
Change From Baseline in FACE-Q Study-Specific Adverse Events: Eyes Scores
Časové okno: Through 24 weeks after final treatment (up to Week 32)

Change from baseline in selected FACE-Q Study-Specific Adverse Events: Eyes patient-reported outcome scores evaluating symptoms directly related to the treatment procedure in the periorbital area according to their respective scoring algorithms and the change from baseline. Higher scores in the FACE-Q® Study-Specific Adverse Events: Eyes outcome are the result of increased symptom severity.
Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Satisfaction with Outcomes Scores
Časové okno: Through 24 weeks after final treatment (up to Week 32)

Change from baseline in selected FACE-Q Satisfaction with Outcomes patient-reported outcome scores evaluating satisfaction related to the treatment procedure according to their respective scoring algorithms and the change from baseline. Higher scores in the FACE-Q® Satisfaction with Outcomes outcome are the result of increased satisfaction.
Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Psychological Function Scores
Časové okno: Through 24 weeks after final treatment (up to Week 32)

Change from baseline in selected FACE-Q Psychological Function patient-reported outcome scores evaluating quality of life related to the treatment procedure according to their respective scoring algorithms and the change from baseline. Higher scores in the FACE-Q® Psychological Function outcome are the result of increased quality of life.
Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Short Form - Skin Feels: Skin Quality Scores
Časové okno: Through 24 weeks after final treatment (up to Week 32)

Change from baseline in selected FACE-Q Short Form - Skin Feels: Skin Quality patient-reported outcome scores evaluating perception of improvement related to the treatment procedure according to their respective scoring algorithms and the change from baseline. Higher scores in the FACE-Q® Short Form - Skin Feels: Skin Quality outcome are the result of increased perception of improvement and satisfaction.
Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Short Form - Skin Looks: Skin Quality Scores
Časové okno: Through 24 weeks after final treatment (up to Week 32)

Change from baseline in selected FACE-Q Short Form - Skin Looks: Skin Quality patient-reported outcome scores evaluating perception of improvement related to the treatment procedure according to their respective scoring algorithms and the change from baseline. Higher scores in the FACE-Q® Short Form - Skin Looks: Skin Quality outcome are the result of increased perception of improvement and satisfaction.
Through 24 weeks after final treatment (up to Week 32)
Incidence of Anti-Drug Antibodies (ADA) to rhPDGF-BB
Časové okno: Baseline through 24 weeks after final treatment (up to Week 32)

Incidence of anti-drug antibodies to rhPDGF-BB will be assessed. ADA titers (quantities) will also be characterized over time.
Baseline through 24 weeks after final treatment (up to Week 32)
Incidence of Neutralizing Antibodies (NAb) to rhPDGF-BB
Časové okno: Baseline through 24 weeks after final treatment (up to Week 32)

Incidence of neutralizing antibodies to rhPDGF-BB. Confirmed ADA-positive samples will be evaluated for neutralizing activity (ability to affect the function of rhPDGF-BB) using a validated cell-based assay.
Baseline through 24 weeks after final treatment (up to Week 32)
Time to Maximum Observed Plasma Concentration (Tmax) of rhPDGF-BB
Časové okno: Predose through Day 7 after treatment; repeated after retreatment, if applicable

Time to maximum observed plasma concentration (Tmax; ng/mL), max concentration (Cmax; ng/mL), measurable plasma concentrations (ng/mL) and, proportion of samples above the lower limit of quantitation (LLOQ; %) for rhPDGF-BB.
Predose through Day 7 after treatment; repeated after retreatment, if applicable
Change From Baseline in Infraorbital Volume
Časové okno: Baseline through 24 weeks after final treatment (up to Week 32)

Quantitative change from baseline in infraorbital tissue volume (cubic millimeters) will be measured using standardized three-dimensional VISIA-CR with PRIMOS imaging and centralized image analysis.
Baseline through 24 weeks after final treatment (up to Week 32)
Change From Baseline in Image Analysis-based Evaluation of Texture/Roughness
Časové okno: Baseline through 24 weeks after final treatment (up to Week 32)

Quantitative change from baseline in infraorbital skin parameter of texture/roughness (reported as a ratio) measured using standardized three-dimensional VISIA-CR with PRIMOS imaging and centralized image analysis.
Baseline through 24 weeks after final treatment (up to Week 32)
Change From Baseline in Image Analysis-based Evaluation of Fine Lines/Wrinkles
Časové okno: Baseline through 24 weeks after final treatment (up to Week 32)

Quantitative change from baseline in infraorbital skin parameters of fine lines/wrinkles (reported as a ratio) measured using standardized three-dimensional VISIA-CR with PRIMOS imaging and centralized image analysis.
Baseline through 24 weeks after final treatment (up to Week 32)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Relationship Between Immunogenicity and Safety and Efficacy Outcomes
Časové okno: Baseline through 24 weeks after final treatment (up to Week 32)

The relationship between anti-drug antibody (ADA) and neutralizing antibody (NAb) status and safety and efficacy outcomes will be evaluated descriptively to characterize the potential clinical relevance of immunogenicity. An evaluation of potential relationship of development of antibodies to rhPDGF-BB and occurrence (number and relative timing) of treatment-emergent adverse events will be performed.
Baseline through 24 weeks after final treatment (up to Week 32)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Lynch Regenerative Medicine

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

9. listopadu 2026

Primární dokončení (Odhadovaný)

30. září 2027

Dokončení studie (Odhadovaný)

30. listopadu 2027

Termíny zápisu do studia

První předloženo

20. října 2026

První předloženo, které splnilo kritéria kontroly kvality

27. října 2026

První zveřejněno (Aktuální)

4. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • LRM-PDGF-IOH-201

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data (IPD) are not planned to be made publicly available or shared with external researchers. Study data will be maintained and disclosed as required by applicable regulatory requirements, the study protocol, and informed consent. Aggregate study results will be reported through ClinicalTrials.gov, as applicable, and may be included in scientific publications, presentations, and regulatory submissions.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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