Phase 2 Evaluation of Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) Injection for the Treatment of Infraorbital Hollowing
NCT07914816, Phase 2, Not yet recruiting, Lynch Regenerative Medicine
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Phase 2 Evaluation of Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) Injection for the Treatment of Infraorbital Hollowing | ClinicalTrials.gov |
| NCT number | NCT07914816 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 75 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Lynch Regenerative Medicine | ClinicalTrials.gov |
| Conditions | Infra-orbital Hollows, Skin Quality Improvement | ClinicalTrials.gov |
| Interventions | RhPDGF-BB, Normal Saline | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence, Severity, and Relationship of Treatment-Emergent Adverse Events (TEAEs) | 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. | ClinicalTrials.gov |
| Primary | Proportion of Participants With ≥1-Grade Improvement on the Canfield Infraorbital Hollow Severity Scale (CIOHS) | 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. | ClinicalTrials.gov |
| Secondary | Responder rate (Proportion of Participants With ≥2-Grade Improvement on the Canfield Infraorbital Hollow Severity Scale (CIOHS)) 12 weeks after final treatment | 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. | ClinicalTrials.gov |
| Secondary | Time Course and Durability of Change From Baseline in Canfield Infraorbital Hollow Severity Scale (CIOHS) Score | 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. | ClinicalTrials.gov |
| Secondary | Investigator-Assessed Global Aesthetic Improvement Scale (GAIS) | 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. | ClinicalTrials.gov |
| Secondary | Participant-Assessed Global Aesthetic Improvement Scale (GAIS) | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in FACE-Q Recovery Early Symptoms Scores | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in FACE-Q Study-Specific Adverse Events: Eyes Scores | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in FACE-Q Satisfaction with Outcomes Scores | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in FACE-Q Psychological Function Scores | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in FACE-Q Short Form - Skin Feels: Skin Quality Scores | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in FACE-Q Short Form - Skin Looks: Skin Quality Scores | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Anti-Drug Antibodies (ADA) to rhPDGF-BB | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Neutralizing Antibodies (NAb) to rhPDGF-BB | 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. | ClinicalTrials.gov |
| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of rhPDGF-BB | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Infraorbital Volume | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Image Analysis-based Evaluation of Texture/Roughness | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Image Analysis-based Evaluation of Fine Lines/Wrinkles | 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. | ClinicalTrials.gov |
| Other | Relationship Between Immunogenicity and Safety and Efficacy Outcomes | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)