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Profhilo
Is Profhilo FDA-Approved?
May 21, 2025
Healthy human skin is naturally rich in collagen, elastin, and hyaluronic acid, which provide essential hydration, elasticity, and resilience. However, these vital components decline with age, leading to skin laxity, fine lines, and a loss of firmness. Environmental factors like sun exposure and pollution further accelerate these changes, fueling demand for effective skin rejuvenation treatments.
Among these treatments, Profhilo stands out for its innovative formulation and unique focus on enhancing skin quality rather than simply adding volume like traditional fillers. While widely popular in many countries, it is important to note that Profhilo is not FDA-approved in the United States—a critical consideration for patients and providers regarding accessibility and regulatory oversight.
This article examines Profhilo’s composition, global approval status, and the implications for those seeking safe, effective skin-enhancing options in the U.S. and beyond.
Key Takeaways
- Profhilo is CE-marked and widely used in Europe, the Middle East, and Asia, but it is not FDA-approved and cannot be legally used or marketed in the United States.
- U.S. medical professionals must avoid administering Profhilo until it receives FDA clearance, as doing so risks legal penalties and compromises patient safety.
- Providers should clearly communicate Profhilo’s unapproved status to patients influenced by international marketing or social media trends.
- Safe and effective FDA-approved alternatives in the U.S. include Skinvive by Juvéderm, Restylane Skinboosters, Radiesse, Sculptra Aesthetic, and Belotero Balance.
- It is important for U.S. practitioners to stay updated on Profhilo’s regulatory progress through clinical trial databases, conferences, industry publications, and manufacturer updates.
- Patient safety, legal compliance, and ethical practice must remain top priorities while awaiting potential future FDA approval.
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Current Approval and Usage of Profhilo
Profhilo is approved for use in multiple countries across Europe, the Middle East, and Asia. Its CE marking confirms compliance with stringent European standards for safety, health, and environmental protection. However, it is important to note that CE marking is not equivalent to U.S. FDA approval.
In regions where Profhilo is permitted, medical professionals legally offer treatments to enhance skin hydration, elasticity, and overall texture by injecting highly concentrated hyaluronic acid. Patients have reported favorable outcomes such as skin tightening and increased radiance, particularly in the face, neck, and décolletage.
Despite these positive international results, Profhilo’s lack of FDA approval means it cannot be legally marketed or used in the United States. Patients and providers familiar with its benefits abroad should be cautious, as its use in the U.S. is prohibited.
Implications for U.S. Medical Professionals
U.S.-based healthcare practitioners must refrain from administering Profhilo until it receives official FDA clearance. Using non-FDA-approved products can expose clinics and practitioners to serious legal consequences, including penalties and potential loss of licensure. Furthermore, offering such treatments may jeopardize patient safety and harm the clinic’s professional reputation.
Practitioners should clearly communicate Profhilo’s unapproved FDA status to patients, particularly those influenced by international marketing or social media trends. Clinics must avoid importing or using Profhilo from unregulated sources, as this constitutes a violation of federal law.
Until official approval is granted, U.S. aesthetic practices must adhere to regulatory guidelines to ensure compliance and uphold high standards of patient care.
Alternative FDA-Approved Treatments
While Profhilo remains unavailable in the U.S., several FDA-approved options provide similar skin-rejuvenating benefits in terms of hydration, texture enhancement, and overall skin quality:
- Skinvive by Juvéderm: A hyaluronic acid-based injectable approved to enhance skin smoothness and hydration. In the ongoing debate of Profhilo vs Skinvive, only Skinvive holds FDA approval for use in the United States.
- Restylane® Skinboosters: Offers hydration and mild plumping effects; certain variants are FDA-approved.
- Radiesse®: A calcium hydroxylapatite-based filler that stimulates collagen production and improves skin texture.
- Sculptra® Aesthetic: Stimulates collagen over time, effective for skin tightening and volume restoration.
- Belotero Balance®: FDA-approved for treatment of moderate-to-severe lines and wrinkles with a smooth finish.
Each of these treatments has undergone rigorous clinical testing and regulatory review, making them reliable choices for practitioners seeking to offer effective and compliant skin rejuvenation therapies. Selecting the most suitable product depends on individual patient skin conditions, aesthetic goals, and medical history.
Monitoring Regulatory Developments
Staying informed about Profhilo’s regulatory progress is crucial for clinicians aiming to integrate this treatment once FDA approval occurs. Providers can track updates through:
- FDA Clinical Trials Database (ClinicalTrials.gov): Lists ongoing studies evaluating Profhilo’s safety and effectiveness in the U.S.
- Medical Aesthetics Conferences: Often provide updates on product trials, regulatory shifts, and new treatment technologies.
- Professional Newsletters and Journals: Subscribe to aesthetic medicine publications for timely updates.
- Manufacturer Updates: Follow IBSA Derma, the maker of Profhilo, for press releases and FDA submission progress.
- Networking with Peers: Staying in touch with industry peers can provide early information on anticipated regulatory changes.
By monitoring these sources, practitioners can stay prepared to integrate Profhilo into their practice once it receives FDA clearance, if and when that occurs.
Conclusion
As it stands, Profhilo is not FDA-approved and therefore cannot be legally marketed or administered in the United States. While it enjoys widespread use and positive reviews internationally, U.S. practitioners must rely on FDA-approved hyaluronic acid injectables that provide comparable benefits in skin rejuvenation.
Prioritizing patient safety, legal compliance, and professional reputation remains paramount. Staying informed and proactive allows medical professionals to maintain ethical practices and foster long-term patient trust.
FAQs
1. What is Profhilo?
Profhilo is an injectable skin treatment containing high concentrations of hyaluronic acid, designed to hydrate and improve skin elasticity.
2. How is Profhilo different from dermal fillers?
Unlike fillers, Profhilo spreads under the skin to stimulate collagen and elastin without adding volume or structure.
3. Where is Profhilo commonly injected?
It is most often used on the face, neck, hands, and décolletage to improve skin tone, texture, and firmness.
4. Is Profhilo safe?
Profhilo has been deemed safe in countries where it is approved, but like all injectables, it can have side effects.
5. How many sessions are needed?
A typical Profhilo treatment involves two sessions spaced four weeks apart, with maintenance treatments recommended every 6-9 months.
6. Are the results from Profhilo permanent?
No, results are temporary and usually last around six months, depending on the individual’s metabolism and skin condition.
7. Can I get Profhilo in the U.S. if I travel abroad?
While patients can receive Profhilo treatments in countries where it is legal, they must ensure treatments are administered by licensed professionals in those regions.
References
Kim MS, Chun KE, Lee DK, Song SH. Evaluation of the Efficacy of an Elastin-Inducing Composition Containing Amino Acids, Copper, and Hyaluronic Acid: Results of an Open Single-Center Clinical Trial Study. Cosmetics. 2022;9(3):51. doi:https://doi.org/10.3390/cosmetics9030051
Health C for D and R. FDA-Approved Dermal Fillers. FDA. Published online November 4, 2021. https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers
What Is Skin Rejuvenation? Verywell Health. https://www.verywellhealth.com/skin-rejuvenation-5120583