Lynch Regenerative Medicine
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.
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,…
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 preg…
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.
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.