Lindus Health, the “anti-CRO” running radically faster, more reliable clinical trials for life science pioneers, has announced its collaboration with Acinonyx Bio, a biotechnology company that uses a unique mix of ingredients made from predominantly plants to kill different types of bacteria, fungi, and viruses effectively, in a cosmetics clinical trial to investigate their topical cream’s ability to treat inflammatory acne.
Inflammatory acne is characterized by red, swollen, and sore blemishes, providing physical discomfort and psychological stress due to its persistent nature and potential to leave permanent scarring. Acne is the most common skin condition in the US, affecting approximately 50 million people.
This study aims to target Propionibacterium acnes (P. acnes), a bacterium that plays a significant role in the development of inflammatory acne. In in vitro studies, it was revealed Acinonyx Bio’s topical cream, ACX, killed P. acnes as rapidly as does benzoyl peroxide, a widely used acne treatment. Benzoyl peroxide products, however, have recently garnered attention for containing a carcinogen, prompting some consumers to seek alternative therapies to manage their acne. ACX does not contain this associated carcinogen in its formulation, and it reduces sebum production, unclogs pores, and absorbs rapidly into the skin to lead to a more rapid clinical effect.
The clinical trial will recruit patients with moderate to severe inflammatory acne and will be carried out under a decentralized clinical trial (DCT) model, providing patients with the flexibility to participate in this essential research within the comfort of their real-world environments. Participants will use the investigational product for a period of six weeks and provide photos for medical assessment as well as feedback on the effectiveness of the topical cream and their satisfaction with the product.
Lindus Health, responsible for providing end-to-end study management, including protocol development, regulatory submissions, recruitment, monitoring, data management and more, will leverage their in-house virtual site and digital marketing capabilities to carry out patient recruitment via digital advertising. They will also design a dedicated study website with pertinent trial information including leveraging their proprietary eClinical platform, CitrusTM, for patients to easily complete pre-screening and eConsent.
“Lindus Health’s involvement in this study underpins our commitment to helping our partners bring safe and effective dermatological therapies to market. Inflammatory acne can significantly diminish quality of life,” states Michael Young, co-founder of Lindus Health. “We are enthusiastic about the opportunity to leverage our unique technical and service-based capabilities in another dermatology study, building on our vast experience in this space.”
“We are optimistic about the development of our topical cream and the effect it will have on patients,” says Alex Michalow, CEO at Acinonyx Bio. “We are incredibly excited to be working with Lindus Health to bring our study to life and aid in the overall journey of potentially bringing a safer alternative to the hands of individuals suffering from inflammatory acne.”
Positive results from this trial would further emphasize the potential of this novel topical cream in the utility of improving appearance in those who experience inflammatory acne.
