Phase 2 Evaluation of Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) Injection for the Treatment of Infraorbital Hollowing
Public ClinicalTrials.gov record NCT07914816. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07914816
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 9, 2026 (Estimated)
- Primary completion
- Sep 30, 2027 (Estimated)
- Completion
- Nov 30, 2027 (Estimated)
- Last update posted
- Nov 4, 2026
2026 – 2027
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Steve Yoelin MD and Associates | Newport Beach | California | 92663 | — |
| Ava T. Shamban M.D., INC | Santa Monica | California | 90404 | — |
| Fulcrum Aesthetics and Surgery | Chicago | Illinois | 60657 | — |
| Aesthetic & Dermatology Center | Rockville | Maryland | 20850 | — |
| Cosmetic Skin & Laser Center | Birmingham | Michigan | 33131 | — |
| Dallas Plastic Surgery Institute | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07914816, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 4, 2026 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07914816 live on ClinicalTrials.gov.