The use of bacteriophage as a form of medical treatment is still not openly available for patients outside Georgia and Russia. However, personal care products that are non-medicinal have different criteria to those of prescribed medication. Several companies have been able to develop skin care products to address commonly shared skin issues. Such products are not classified as prescription medication and therefore are available openly to consumers.
Personal skin care products with phages
As the interest in the microbiome grows, more research is being aimed towards understanding the unique balance of every individuals’ microbiota. It is in this balance that many are finding answers to the prevention and treatment of conditions. The role of bacteriophages is a vital one as from this viewpoint, they are not only seen as bacteria killers but also as key players who help achieve balance within the microbiota.
Phortify Probiotic Serum by Phyla
Phi Therapeutics Inc. co-founders, Yug Varma and Maria Cho have made it their mission to change the perspective of how society views chronic conditions like acne. Phyla, a brand of Phi Therapeutics Inc., has recently announced the results from the clinical study of its Phortify Probiotic Serum, containing probiotic phages PHIT-101 that target Cutibacterium acnes, formerly known as Propionibacterium. The results revealed a link between the reduction of C. acnes bacteria and an improvement in acne occurrence and overall skin health.
The randomized controlled trial tested for three end goals:
- if the bacteriophages reduced C. acnes on the skin
- if the C. acnes reduction resulted in blemish control
- if balancing the microbiota resulted in healthier skin
The trial lasted for 8 weeks and involved 90 participants between the ages of 12 and 35. Phyla’s Phortify Probiotic Serum, containing the natural bacteriophage against C. acnes was given to the subjects and compared against the placebo group that was not treated with the phage serum. After 8 weeks, subjects that used the serum showed significantly improved Investigator’s Global Assessment (IGA) scores compared to the placebo group. The correlation between C. acnes reduction and clear skin demonstrated a causal link between C. acnes and acne.
Observations from the trials revealed that the C. acnes bacteriophage did not simply act as a targeted bacteria killer, but rather, as a balancer to the skin’s microbiota. The phages specifically diminished the overgrown pathogenic strains of C. acnes RT4, RT5, and RT8 which are present in patients with acne, whilst allowing RT6 to develop. RT6 is a C. acnes strain that is present in healthy skin microbiota. Consequently, the diminishing of the overgrowing population of pathogenic strains of C. acnes, also led to the overall decrease of the Cutibacterium acnes present. The decrease also gave other bacteria a chance to proportionally share the given microbiota. This could be what was also reflected as the overall healthier skin that was observed on the participants after the trial.
Phage Serum by Ellis Day Skin Science
Balancing Phage Serum (formerly known as Wild Resilience) was the first product released by Ellis Day Skin Science, a brand of SmartPhage Inc., with the aim to help rebalance the skin microbiota. Ellis Day Skin Science is the first company that has both clinical and DNA sequencing data to showcase the ability of the phages used in their products, to act as the balancers of the skin microbiome.
The rebalance of the skin microbiota was achieved by introducing the C. acnes bacteriophage blend known as Cutiphage, which targets specific bacteria that are associated with breakouts and blemishes, resulting in redness and inflammations of the skin. The diminishment of such bacteria also allows the development and growth of good bacteria in the skin microbiome, which resulted in overall healthy skin.
The initial clinical trial was a 12-week study conducted on women with acne. The outcome of the trial revealed a 99.9% reduction in both inflammatory and non-inflammatory acne lesions, with no adverse effects such as; dryness, irritation, redness, or inflammation. DNA sequencing of the participant’s skin swabs after the participants used the bacteriophage blend for 12 weeks, showed that there was a reduction of specific harmful C. acnes, whilst also showing an increase in the beneficial C. acnes strains. The rebalance of the bacterial population in the participants’ skin microbiota resulted in overall healthy, radiant, and resilient skin.
After the success of their Balancing Phage Serum, they have also released a second product; Hydrating Phage Serum which contains the same blend of bacteriophages as the Balancing Phage Serum, with the addition of hyaluronic acid for the prevention of moisture loss of the skin.
PhagoDerm gel by Micromir
PhagoDerm by Micromir is a gel that contains a complex of 64 types of bacteriophages; Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus warneri, Staphylococcus haemolyticus, Staphylococcus capitis, Staphylococcus caprae, Staphylococcus suсcinus, Corynebacterium spp., Enterobacter spp., Enterococcus faecalis, Acinetobacter baumannii, Stenotrophomonas maltophilia, Citrobacter freundii, Propionibacterium acnes, Pseudomonas aeruginosa, Klebsiella spp., Proteus vulgaris, Proteus mirabilis, Escherichia coli and Enterococcus faecium (formerly called group D Streptococci Enterococcus faecium). The gel is used to stabilize the skin microbiota and preventing the development of pathogenic strains of bacteria, commonly found on the skin.
The use of bacteriophage for cosmetic purposes has allowed the researchers to address persistent skin conditions, whilst not disturbing the natural skin flora or having the gel interact with organs or system. Micromir’s product has been approved for consumers in many categories including; newborns, pregnant and nursing women as a safe antibacterial agent.
PhagoDerm gel comes in a 50 ml bottle with a dispenser and protective cap. The composition of the gel composition includes; active substances: sterile suspension of phage particles in saline; excipients: purified water, carbopol, calendula extract, and nipazole.
Micromir has developed additional health care products that similar to PhagoDerm, address pathogenic strains of bacteria in other parts of the body. Micromir has signed off to distribute their health care products with bacteriophages to Japan, as of February 2020.
BX001 by BiomX
BiomX is a clinical-stage biotechnology company that is developing both natural and engineered phage cocktails. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.
BX001 is a topical gel composed of a cocktail of natural bacteriophages that target Cutibacterium acnes. The aim of the study is to provide a clinically meaningful improvement of the appearance of acne-prone skin. The Phase 1 results showed positive results, in which the BX001 bacteriophage cocktail demonstrated a statistically significant reduction of C. acnes levels compared to the placebo. BiomX has announced that the first subject has been dosed in Phase 2 cosmetic clinical study of BX001 in subjects with mild-to-moderate acne.
The Phase 2 cosmetic clinical study using BX001 will evaluate a larger number of subjects with acne-prone skin over 8 to 12 weeks. The study is a 12-week randomized, single centre, double-blind, placebo-controlled trial involving 140 individuals with mild-to-moderate acne vulgaris. Subjects will be randomized into two cohorts: BX001 or placebo in a 1:1 ratio. All subjects will self-administer BX001 or placebo twice daily.
The key endpoints will evaluate the safety, tolerability, and efficacy of BX001. Efficacy parameters include:
- measurement of inflammatory and non-inflammatory lesions
- IGA score
- reduction of C. acnes bacterial levels on subjects’ skin
Results from the 8-week point are expected in the third quarter of 2021 and full analysis including the 12-week point is expected in the fourth quarter of 2021.
Other bacteriophage applications in skin care products
Whilst some health products are utilizing natural lytic phages, others are developing products based on unique bacteriophage biology. One of such phage mechanisms is endolysins or phage lysins. These are cell wall hydrolyzing enzymes that bacteriophages produce during the final stage of the lytic cycle in order to break down the bacterial cell wall and release new phages.
Staphefekt by Micreos is the world’s first endolysin that is available for human use. The product was created to specifically target a range of strains of Staphylococcus aureus, including resistant strains such as MRSA. Under the brand Gladskin, there is a variety of skin care products containing Staphefekt to help address various skin conditions with an infectious component such as; acne, eczema, rosacea, and skin irritation.
Whilst the use of bacteriophages as medical treatments are currently still being looked into from the regulatory framework, the field for personal care products has also shown great interest in the use of phages. With the growing interest in the importance of the human microbiome, bacteriophages are looked at as key players in helping to achieve a natural balance within the various microbiotas found in living organisms.