Infra-orbital HollowsPhase 2NCT07914816
Phase 2 Evaluation of Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) Injection for the Treatment of Infraorbital Hollowing
A Phase 2 study testing RhPDGF-BB and Normal Saline in people with Infra-orbital Hollows and Skin Quality Improvement, run by Lynch Regenerative Medicine at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Infra-orbital Hollows, Skin Quality Improvement
- What is being tested?
- RhPDGF-BB and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Nov 2026to 30 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Cosmetic Skin & Laser Center
Birmingham, Michigan, 33131
Susmita Jain, 1 586-668-7003, susmita@boydbeauty.com
Charles Boyd, MD
Fulcrum Aesthetics and Surgery
Chicago, Illinois, 60657
Lisa Hurley, 810-599-4196, lhurley@fulcrumaesthetics.com
David Hill, MD
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
Brianna Escamilla, 214-821-9114, brianna.escamilla@dpsi.org
Rod Rohrich, MD
Steve Yoelin MD and Associates
Newport Beach, California, 92663
Shiraz Rezaei, 949-548-2711, srezaei.symd@gmail.com
Steve Yoelin, MD
Aesthetic & Dermatology Center
Rockville, Maryland, 20850
Jessica Baccouche, 301-610-0663, jessica@aederm.com
Lawrence Green, MD
Ava T. Shamban M.D., INC
Santa Monica, California, 90404
Tamar Melkonian, 310-828-2282 ext. 128, tamar@avamd.com
Ava Shamban, MD
About this study
Official title: 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
Read more
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.
Read the detailed description
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.
- Conditions
- Infra-orbital Hollows, Skin Quality Improvement
- Being tested
- RhPDGF-BB, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhPDGF-BBBiological
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.
Normal SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose rhPDGF-BB (37.5 µg) per infraobital region | Experimental | 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. Receives: Biological: RhPDGF-BB |
| High-Dose rhPDGF-BB (75 µg) per infraobital region | Experimental | 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. Receives: Biological: RhPDGF-BB |
| Placebo (Normal Saline) | Placebo comparator | 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, Severity, and Relationship of Treatment-Emergent Adverse Events (TEAEs)
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.
Measured: 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)
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.
Measured: 12 weeks after final treatment (Week 12 after initial treatment or Week 20 for participants retreated at Week 8)
Secondary outcomes (16)
Responder rate (Proportion of Participants With ≥2-Grade Improvement on the Canfield Infraorbital Hollow Severity Scale (CIOHS)) 12 weeks after final treatment
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.
Measured: 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
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.
Measured: Baseline through 24 weeks after final treatment (up to Week 32)
Investigator-Assessed Global Aesthetic Improvement Scale (GAIS)
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.
Measured: Through 24 weeks after final treatment (up to Week 32)
Participant-Assessed Global Aesthetic Improvement Scale (GAIS)
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.
Measured: Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Recovery Early Symptoms Scores
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.
Measured: Baseline through 14 days after each treatment
Change From Baseline in FACE-Q Study-Specific Adverse Events: Eyes Scores
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.
Measured: Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Satisfaction with Outcomes Scores
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.
Measured: Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Psychological Function Scores
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.
Measured: Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Short Form - Skin Feels: Skin Quality Scores
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.
Measured: Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Short Form - Skin Looks: Skin Quality Scores
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.
Measured: Through 24 weeks after final treatment (up to Week 32)
Incidence of Anti-Drug Antibodies (ADA) to rhPDGF-BB
Incidence of anti-drug antibodies to rhPDGF-BB will be assessed. ADA titers (quantities) will also be characterized over time.
Measured: Baseline through 24 weeks after final treatment (up to Week 32)
Incidence of Neutralizing Antibodies (NAb) to rhPDGF-BB
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.
Measured: Baseline through 24 weeks after final treatment (up to Week 32)
Time to Maximum Observed Plasma Concentration (Tmax) of rhPDGF-BB
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.
Measured: Predose through Day 7 after treatment; repeated after retreatment, if applicable
Change From Baseline in Infraorbital Volume
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.
Measured: Baseline through 24 weeks after final treatment (up to Week 32)
Change From Baseline in Image Analysis-based Evaluation of Texture/Roughness
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.
Measured: Baseline through 24 weeks after final treatment (up to Week 32)
Change From Baseline in Image Analysis-based Evaluation of Fine Lines/Wrinkles
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.
Measured: Baseline through 24 weeks after final treatment (up to Week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start9 Nov 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infra-orbital HollowsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1:1 ratio to one of three parallel treatment groups. Randomization is stratified by study site and baseline severity of infraorbital hollowing. An initial sentinel cohort (n=9 comprised of participants randomized to low-dose (n=6) and placebo (n=3) is enrolled and dosed in a sequential, staggered manner to assess initial safety and tolerability before progression to full cohort enrollment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lynch Regenerative Medicine
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914816
- Sponsor's protocol ID
- LRM-PDGF-IOH-201
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07914816
- Acronym / sponsor ID
- LRM-PDGF-IOH-201
- Conditions
- Infra-orbital Hollows, Skin Quality Improvement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Lynch Regenerative MedicineResearch network
- Study start
- 9 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomized in a 1:1:1 ratio to one of three parallel treatment groups. Randomization is stratified by study site and baseline severity of infraorbital hollowing. An initial sentinel cohort (n=9 comprised of participants randomized to low-dose (n=6) and placebo (n=3) is enrolled and dosed in a sequential, staggered manner to assess initial safety and tolerability before progression to full cohort enrollment.
| Arm | Type | Receives |
|---|---|---|
| Low-Dose rhPDGF-BB (37.5 µg) per infraobital region | Experimental | Biological: RhPDGF-BBParticipants 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. |
| High-Dose rhPDGF-BB (75 µg) per infraobital region | Experimental | Biological: RhPDGF-BBParticipants 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. |
| Placebo (Normal Saline) | Placebo comparator | Drug: Normal SalineParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhPDGF-BBRecombinant 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. | Biological | High-Dose rhPDGF-BB (75 µg) per infraobital region, Low-Dose rhPDGF-BB (37.5 µg) per infraobital region |
| Normal SalineSterile 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. | Drug | Placebo (Normal Saline) |
Primary outcome
Incidence, Severity, and Relationship of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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.
Proportion of Participants With ≥1-Grade Improvement on the Canfield Infraorbital Hollow Severity Scale (CIOHS)
Time frame: 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.
16 secondary outcomes
Responder rate (Proportion of Participants With ≥2-Grade Improvement on the Canfield Infraorbital Hollow Severity Scale (CIOHS)) 12 weeks after final treatment
Time frame: 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
Time frame: Baseline through 24 weeks after final treatment (up to Week 32)
Investigator-Assessed Global Aesthetic Improvement Scale (GAIS)
Time frame: Through 24 weeks after final treatment (up to Week 32)
Participant-Assessed Global Aesthetic Improvement Scale (GAIS)
Time frame: Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Recovery Early Symptoms Scores
Time frame: Baseline through 14 days after each treatment
Change From Baseline in FACE-Q Study-Specific Adverse Events: Eyes Scores
Time frame: Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Satisfaction with Outcomes Scores
Time frame: Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Psychological Function Scores
Time frame: Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Short Form - Skin Feels: Skin Quality Scores
Time frame: Through 24 weeks after final treatment (up to Week 32)
Change From Baseline in FACE-Q Short Form - Skin Looks: Skin Quality Scores
Time frame: Through 24 weeks after final treatment (up to Week 32)
Incidence of Anti-Drug Antibodies (ADA) to rhPDGF-BB
Time frame: Baseline through 24 weeks after final treatment (up to Week 32)
Incidence of Neutralizing Antibodies (NAb) to rhPDGF-BB
Time frame: Baseline through 24 weeks after final treatment (up to Week 32)
Time to Maximum Observed Plasma Concentration (Tmax) of rhPDGF-BB
Time frame: Predose through Day 7 after treatment; repeated after retreatment, if applicable
Change From Baseline in Infraorbital Volume
Time frame: Baseline through 24 weeks after final treatment (up to Week 32)
Change From Baseline in Image Analysis-based Evaluation of Texture/Roughness
Time frame: Baseline through 24 weeks after final treatment (up to Week 32)
Change From Baseline in Image Analysis-based Evaluation of Fine Lines/Wrinkles
Time frame: Baseline through 24 weeks after final treatment (up to Week 32)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RhPDGF-BB and Normal Saline in people with Infra-orbital Hollows and Skin Quality Improvement, run by Lynch Regenerative Medicine at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, Severity, and Relationship of Treatment-Emergent Adverse Events (TEAEs) (time frame: From first study injection through 24 weeks after the final treatment (up to Week 32 for participants receiving retreatment at Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.