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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. oktober 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

75

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Newport Beach, California, Forente stater, 92663
        • Steve Yoelin MD and Associates
        • Hovedetterforsker:
          • Steve Yoelin, MD
        • Ta kontakt med:
      • Santa Monica, California, Forente stater, 90404
        • Ava T. Shamban M.D., INC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ava Shamban, MD
    • Illinois
      • Chicago, Illinois, Forente stater, 60657
        • Fulcrum Aesthetics and Surgery
        • Hovedetterforsker:
          • David Hill, MD
        • Ta kontakt med:
    • Maryland
      • Rockville, Maryland, Forente stater, 20850
        • Aesthetic & Dermatology Center
        • Hovedetterforsker:
          • Lawrence Green, MD
        • Ta kontakt med:
    • Michigan
      • Birmingham, Michigan, Forente stater, 33131
        • Cosmetic Skin & Laser Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles Boyd, MD
    • Texas
      • Dallas, Texas, Forente stater, 75231
        • Dallas Plastic Surgery Institute
        • Hovedetterforsker:
          • Rod Rohrich, MD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Biologisk: 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.
Eksperimentell: 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.
Biologisk: 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.
Placebo komparator: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence, Severity, and Relationship of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Responder rate (Proportion of Participants With ≥2-Grade Improvement on the Canfield Infraorbital Hollow Severity Scale (CIOHS)) 12 weeks after final treatment
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relationship Between Immunogenicity and Safety and Efficacy Outcomes
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Lynch Regenerative Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

9. november 2026

Primær fullføring (Antatt)

30. september 2027

Studiet fullført (Antatt)

30. november 2027

Datoer for studieregistrering

Først innsendt

20. oktober 2026

Først innsendt som oppfylte QC-kriteriene

27. oktober 2026

Først lagt ut (Faktiske)

4. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LRM-PDGF-IOH-201

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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