How to Use the FACE-Q Survey to Collect High-Quality Clinical Data for Fillers and PRP Treatments
In today's aesthetic medical device market, dermal fillers and PRP (platelet-rich plasma) therapies are two of the fastest-growing non-surgical treatments. With rising demand comes greater scrutiny from regulators, clinicians, and patients.
Medical device manufacturers are under increasing pressure to demonstrate not only safety and efficacy, but also patient-reported outcomes (PROs) that reflect real-life satisfaction and quality of life improvements.
One of the most effective ways to capture this evidence is through the FACE-Q survey, a validated, modular patient-reported outcome instrument specifically designed for facial aesthetics.
Regulatory Context: Dermal Fillers Under EU MDR
Dermal fillers are not considered "medical devices with a medical purpose" when used strictly for aesthetic/cosmetic indications (e.g., wrinkle filling, lip augmentation).
However, the EU legislator wanted to regulate certain "Annex XVI products": products without an intended medical purpose but which function similarly to medical devices and pose comparable risk.
Applicable MDR Provisions
Extends the regulation to Annex XVI products without an intended medical purpose (e.g., fillers, lipolysis devices, lasers for hair removal, etc.).
States that for Annex XVI products, common specifications (CS) will be adopted by the Commission. These CS cover risk management, clinical evaluation, and post-market clinical follow-up (PMCF) requirements.
Governs Clinical Evaluation. Manufacturers of fillers must demonstrate safety and performance (or "safety and claimed benefit" since there is no medical benefit). They must perform a Clinical Evaluation Report (CER) and often PMCF studies.
Why Collect Patient-Reported Outcomes in Aesthetics PMCF Activities?
Traditional clinical endpoints (e.g., wrinkle severity scales, physician-rated improvement scores, before/after photographs) are essential, but they don't capture the patient's opinion.
Regulators and notified bodies now expect manufacturers of HA fillers, collagen stimulators, and PRP skin rejuvenation products to show not just what clinicians see, but what patients actually experience.
This is where FACE-Q becomes a game-changer.
What Is the FACE-Q?
The FACE-Q Aesthetics module is a scientifically validated PRO questionnaire. It is FDA-qualified as a Medical Device Development Tool (MDDT) for use in aesthetic clinical trials and accepted by most notified bodies in the EU including BSI, TÜV SÜD, and SGS.
It offers a series of modular scales that can be combined depending on the treatment type (filler, PRP, botulinum toxin, or skin rejuvenation). Each scale is Rasch-transformed into a 0–100 score, making it statistically robust and easy to analyze.
How You Can Use FACE-Q for Fillers and PRP Medical Devices
When collecting clinical data for hyaluronic acid fillers (such as nasolabial fold or cheek augmentation products) or PRP skin rejuvenation, FACE-Q provides three tiers of evidence:
Device-Proximal (Anatomic Target)
Direct measurement of the treated area (e.g., nasolabial folds, cheeks).
Global Appearance
Patient's perception of their overall facial attractiveness and youthfulness.
Patient Life Impact (QoL/Outcome)
Quality of life, psychological function, and social confidence improvements.
This layered approach ensures manufacturers can demonstrate not only visible correction, but also real-world patient benefits including quality of life and global facial appearance.
Key FACE-Q Scales for Fillers and PRP
NLF Scale (Appraisal of Lines: Nasolabial Folds)
Patient perception of smile lines.
Depth, visibility, attractiveness impact, satisfaction.
Rasch-transformed 0–100 score.
Device-proximal measure for fillers targeting NLF.
Overall Facial Appearance (Satisfaction with Facial Appearance)
Global view of whole face.
Attractiveness, youthfulness, balance, confidence.
0–100 score reflecting global improvement.
Prevents criticism that "you fixed the fold but the patient doesn't feel better overall."
QoL / Outcome Scales
Overall happiness, recommendation, expectations met.
Confidence, self-esteem, reduced aging perception.
Comfort in public/social situations, being photographed.
Moves beyond anatomy to show psychosocial benefit and strengthen the benefit–risk case.
Summary Table
| FACE-Q Category | Scale(s) | What it Measures | Why Important |
|---|---|---|---|
| Device-proximal | Appraisal of Lines: NLF | Unattractiveness of folds | Direct filler target |
| Global appearance | Satisfaction with Facial Appearance | Attractiveness and balance of whole face | Demonstrates positive effect on global appearance |
| QoL / Outcome | Satisfaction with Outcome, Psychological Function, Social Function | Patient satisfaction, emotional well-being | Demonstrates impact on quality of life |
Typical Study Design Using FACE-Q for Fillers and PRP
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Baseline (Day 0)
FACE-Q modules + demographics, medical history, photos.
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Day 7–14
Safety/tolerability check, optional early satisfaction.
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Week 8–12
Primary window – FACE-Q (NLF + global + QoL), GAIS (patient & clinician), photos.
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Month 6
Durability check – FACE-Q + GAIS, record touch-ups.
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Month 9–12
Optional: Extended persistence.
How MILO Makes FACE-Q Data Collection Easier
Collecting high-quality survey data can be logistically challenging. The MILO platform offers a Survey model for PMCF activities that digitizes FACE-Q, making studies easier to run:
ePRO/Survey Access
Access on smartphone, tablet, or PC.
Automated Visit Reminders
Never miss a follow-up visit.
ISO 14155 & GDPR Compliance
Fully regulatory-compliant data collection.
Real-Time Dashboards
For investigators and sponsors.
Multilingual Support
Validated FACE-Q translations.
Integration
With clinical outcomes and safety data.
MILO turns FACE-Q into a seamless digital workflow, ensuring higher completion rates and regulatory-grade evidence.
Check out the testimonial from RegenLab, a leading Swiss company specializing in PRP manufacturing for aesthetic applications.
PMCF Method: How ECLEVAR Will Run It
Design: Prospective case series in routine care (PMCF). No randomization, no experimental procedures.
Expert Advisory
Prof. Luc Teot
MD PhD, Chirurgien plasticien
Directeur de CICAT Occitanie, CHU de Montpellier • Président de la SFFPC • Président du CATEL • Administrateur de EWMA
Roles & Logistics (Compliance-First)
Product Flow
Ideally Sponsor → Sites (Investigators). ECLEVAR does not store or inject product; we manage study operations.
Distribution
If needed, ECLEVAR can arrange 3PL logistics with full traceability, but Investigators remain end-users.
Sites
Qualified physicians already using HA fillers in practice.
Approvals & Start-up
CPP/ANSM (France) or local equivalents, site contracts, training, GDPR materials.
Patients
Consecutive eligible adults treated within intended use; written informed consent required.
Data Collection (ePRO via MILO)
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Day 0:
Baseline FACE-Q modules, demographics, photos.
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Day 7–14:
Adverse-event checklist, optional satisfaction.
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Week 8–12:
FACE-Q (NLF + global + QoL), GAIS, photos.
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Month 6:
FACE-Q + GAIS; retreatment/touch-ups recorded.
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(Optional) Month 9–12:
Durability extension.
Clinician Outcomes & Safety
GAIS (clinician), standardized photography, injection details, AE/SAE capture per ISO 14155.
Data Management & Analysis
- Rasch conversion to 0–100.
- Primary endpoint: NLF score change baseline → Week 12.
- Secondary endpoints: Global appearance, Outcome, Psychological Function, durability.
- Multiplicity control; MMRM or MI for missing data; predefined responder definitions.
Deliverables
Protocol & ICF, ePRO setup, site package, monitoring, SAP, and final PMCF report for your technical documentation.
Quick Answers (For Sponsors)
Q1: Which FACE-Q modules do you recommend?
We recommend multiple modules (NLF + overall appearance + QoL/Outcome).
Q2: Who handles FACE-Q licensing?
ECLEVAR will purchase a project-specific FACE-Q license (or use sponsor's license).
Q3: How does the PMCF workflow operate?
PMCF runs via investigators in routine care; Sponsor supplies product to sites; ECLEVAR handles study ops, ePRO, monitoring, and reporting.
Cost and Licensing Considerations
FACE-Q requires a license for use in clinical trials. Costs are calculated per scale, per patient, with a $15,000 minimum project fee.
Example:
- 3 scales × 30 patients = $22,500
- 2 scales × 20 patients = $15,000 (minimum applies)
Key Takeaway
For dermal fillers and PRP therapies, the FACE-Q survey is one of the most reliable tools to capture patient-reported outcomes.
Combined with MILO's digital ePRO platform and ECLEVAR's PMCF expertise, manufacturers can generate high-quality, regulator-ready evidence that demonstrates:
Target anatomy → Whole face → Patient's life
Case Study: ECLEVAR + MILO Help RegenLab Achieve BSI Acceptance for Aesthetic Medical Devices
Client
RegenLab – a Swiss-based leader in regenerative medicine technologies, specializing in platelet-rich plasma (PRP) and hyaluronic acid (HA) combination products for aesthetic and therapeutic use.
Challenge
RegenLab needed to comply with EU MDR requirements for two aesthetic devices combining PRP and HA technologies. Specifically, they required:
- A PMCF Survey to capture real-world performance and patient experience.
- A Clinical Investigation to evaluate safety, tolerance, and perceived performance with validated clinical and patient-reported outcomes.
- High-quality PRO data acceptable to their Notified Body (BSI) as part of MDR technical documentation.
Traditional survey and paper-based data collection methods risked incomplete responses, missing data, and regulatory non-compliance.
Solution: ECLEVAR + MILO
ECLEVAR partnered with RegenLab to design and execute both a PMCF Survey and a Clinical Investigation using the MILO digital ePRO platform.
Key Elements:
- Validated surveys integrated: MILO deployed FACE-Q Aesthetics modules (NLF, Satisfaction with Facial Appearance, Satisfaction with Outcome, Psychological Function) and EQ-5D-5L for quality of life, alongside clinical measures (WSRS, GAIS, 3D imaging).
- Two product strategies: PMCF Survey to gather large-scale, real-world feedback from patients and physicians. Clinical Investigation to generate controlled data on safety, usability, and patient-perceived outcomes.
- Digital ePRO capture: Patients completed surveys via smartphone, tablet, or computer, ensuring convenience and compliance.
- Automated reminders: MILO reduced missing data by guiding patients to complete surveys at baseline, Day 28, and Day 84.
- Regulatory compliance: All processes were ISO 14155 and GDPR compliant, producing an auditable dataset ready for Notified Body review.
Results
High data quality: >95% completion rate for FACE-Q and EQ-5D-5L surveys.
Patient engagement: Digital convenience significantly reduced dropout rates.
Comprehensive dataset: Combined clinical endpoints (WSRS, GAIS, LifeViz® 3D imaging) with validated PROs.
Dual strategy success: Both the PMCF Survey and the Clinical Investigation delivered strong evidence across two RegenLab products.
Regulatory acceptance: The PMCF package, including digital survey results, was accepted by BSI under MDR.
Impact
With ECLEVAR's expertise and the MILO platform, RegenLab successfully demonstrated:
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platform has transformed the way we manage patient-reported outcomes — making data collection seamless, compliant, and highly reliable. MILO gives our investigators and KOLs real-time visibility on study progress, which significantly improves both the quality of our research and the satisfaction of our clinical partners."
Key Takeaway
For aesthetic device manufacturers (fillers, PRP, HA-based products), combining a PMCF Survey with a Clinical Investigation, and collecting data digitally through MILO, ensures a complete, regulator-ready evidence package.
ECLEVAR's model — CRO expertise + digital PRO technology — delivers the robust clinical and survey data required for Notified Body acceptance under MDR.
Ready to Collect High-Quality FACE-Q Data?
Let ECLEVAR and MILO help you design and execute a regulatory-ready PMCF study for your aesthetic devices.
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