Restoring skin integrity without aesthetic defects remains one of the most challenging issues in dermatology and surgery. When an injury affects the deep layers of the dermis and destroys the basement membrane—whether through a linear surgical incision or an extensive area of burn or severe inflammation—the risk of scarring, hyperpigmentation, and chronic inflammation increases significantly. The skin's capacity for full regeneration is determined by genetic factors, overall health, and numerous external circumstances; therefore, even when all wound management standards are followed, it is not always possible to avoid pronounced sequelae.

It is well known that fetal skin heals without scars in the presence of amniotic fluid, which plays a key role in maintaining the integrity and maturity of the integument in utero. This observation served as the starting point for seeking ways to translate embryonic regenerative potential into postnatal clinical practice. In 2025, a study published in Annals of Case Reports reported the first clinical cases of using ViX001, a sterile, purified fraction of human amniotic fluid, to heal facial abrasions and recalcitrant acne lesions without scarring or post-inflammatory pigmentation [1].

Clinical Cases: Traumatic Abrasion and Recalcitrant Acne

ViX001 (developed by Neobiosis, USA) is a purified and sterilized fraction of amniotic fluid obtained from rigorously screened donors during term pregnancy and elective cesarean section. The product is supplied in 1 mL cryovials with a total protein concentration of approximately 1 mg/mL. Before use, the vial is thawed and stored in a refrigerator for no more than one week to maintain bioactivity and sterility [1].

The first clinical case describes a 27-year-old man with an extensive traumatic abrasion on his forehead (above the right eyebrow) sustained from impact with a steering wheel during a motor vehicle accident. The patient self-administered undiluted ViX001 topically to the affected area once daily. An immediate analgesic effect was noted after the very first application. With daily use, a rapid reduction in local inflammation and edema was observed, along with signs of progressive epidermal regeneration. By day 14, complete re-epithelialization was achieved, restoring normal skin texture and tone. Notably, there were no signs of scarring, dyspigmentation, or structural irregularities in the trauma zone [1].

The second case involves a 13-year-old female patient with severe acne recalcitrant to standard therapy. The lesions (comedones and inflammatory elements) were primarily distributed across the forehead and both cheeks, with relative sparing of the nasal region. The condition negatively impacted the girl's self-esteem and her participation in school activities. During a three-week course, the patient applied ViX001 twice daily, pre-diluted 1:10 in physiological saline. For convenience, the weekly dose (3 mL of diluted solution) was distributed into three vials and kept refrigerated. A rapid and progressive reduction in the number of lesions was observed during treatment. By the end of the third week, the inflammatory and comedonal lesions had practically resolved, and the skin was fully re-epithelialized with no evidence of scarring or post-inflammatory hyperpigmentation [1, 5].

Potential Mechanisms of Action: From Fetal Microenvironment to the Patient's Skin

Previously, researchers have demonstrated that amniotic fluid and its derived exosomes possess pronounced anti-inflammatory and regenerative potential in severe tissue injuries, including burns and chronic ulcers [3, 4]. In utero, this biological resource provides protection and maturation for fetal epithelial tissues, including the skin and mucosa, and prepares them for future contact with the microbiota [2, 5].

Regarding skin regeneration after trauma, as seen in the first clinical case, it is important to note that a loss of sebaceous gland function often accompanies deep injuries. Due to a sebum deficiency, the skin in the wound area becomes more vulnerable to desiccation, UV radiation, and microbial colonization. According to the authors, ViX001 acts as a bioactive "scaffold" enriched with extracellular vesicles (exosomes of approximately 100–150 nm) containing lipids, proteins, nucleic acids, and glycoproteins [1, 2]. These components can stabilize the epithelium, modulate the immune response, and support tissue regeneration, creating conditions for healing with minimal fibrous transformation.

In the second case of severe acne, sebum hypersecretion and microbial imbalance play key roles, triggering inflammatory cascades and the formation of nodular and cystic lesions. The modern view of acne is increasingly shifting from simple bacterial reduction to the modulation of the skin's microbiome ecosystem. In this context, amniotic fluid is considered a potential regulator of the skin microenvironment due to its inherently anti-inflammatory and immune-"training" profile, which normally helps the fetus prepare for future microbial colonization [2, 5].

Thus, in both clinical scenarios, ViX001 may help restore the balance between barrier function, immune response, and skin microbiota: in trauma, by compensating for lost protective factors and controlling inflammation; in acne, by normalizing the local microenvironment and restraining destructive inflammatory processes.

Practical Significance and Limitations for Aesthetic Medicine

The presented cases demonstrate the potential of purified amniotic fluid as a topical biological agent that supports healing with minimal risk of scarring and post-inflammatory pigmentation. For skincare practitioners, this offers interesting perspectives on the comprehensive management of patients with severe traumatic facial injuries, burns, chronic ulcers, and recalcitrant acne, where the goal of treatment is not only to resolve the condition but also to preserve skin quality [3–5].

At the same time, the widespread adoption of this approach is limited by several factors. First are the ethical aspects of obtaining amniotic fluid, which require strict adherence to donor protocols and safety standards. Additionally, the method requires stringent manufacturing procedures: source material control, purification and sterilization, freezing and storage conditions, and the preservation of the biological activity of extracellular vesicles and other components [1, 4]. Finally, as these are currently isolated clinical observations, large-scale controlled trials are necessary to evaluate efficacy, optimal dosages, and application regimens before moving to broad use [3, 5].

Nevertheless, the described cases confirm that this biological resource, shaped by millions of years of evolution to protect and regenerate the fetus, can become an important tool in the arsenal of aesthetic and restorative dermatology. For specialists working with patients whose skin quality is at stake, this direction deserves close attention.

References

1. Goldschmidt-Clermont P.J., Montenegro R., Rojas K. et al. First applications of purified and sterile human amniotic fluid for the successful healing of abrasion and acne lesions of the face. Ann Case Rep 2025; 10(3): 102316. doi:10.29011/2574-7754.102316.
2. Goldschmidt-Clermont P.J., Hubinont C., Goldschmidt A.J.P. et al. Pregnancy, a unique case of heterochronic parabiosis and peripartum cardiomyopathy. Front Biosci (Landmark Ed) 2021; 26: 666–672.
3. Kweh M.F., Parks M., Salerno A. et al. Topical application of purified amniotic fluid accelerated healing of full-thickness burns, negating the need for skin grafts: a case report. J Wound Manag Res 2023; 19: 53–58.
4. Goldschmidt-Clermont P.J., White I.A. First case of accelerated healing of a recalcitrant diabetic ulcer using purified amniotic fluid. Ann Case Rep 2023; 8: 1463.
5. Visscher M.O., Carr A.N., Narendran V. Epidermal immunity and function: origin in neonatal skin. Front Mol Biosci 2022; 9: 894496.