RhPDGF-BB for Dark Circles Under the Eyes
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults aged 21 to 65 with moderate to severe under-eye hollows (infraorbital hollowing) who want treatment for this condition. People outside this age range or without significant under-eye hollows cannot participate.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB)
Trial Overview
The study tests injections of rhPDGF-BB, a lab-made growth factor, at two different doses versus placebo (salt water) in the area under the eyes. It aims to see if these injections are safe and help improve under-eye hollowness over about six months.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lynch Regenerative Medicine
Lead Sponsor
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