EXECUTIVE SUMMARY
This case study showcases a scar treatment project by a US-based biotechnology company, leveraging fibromodulin-based peptides. Facing the challenge of enhancing both cosmetic and functional wound outcomes, ethica CRO employed the Northwestern University Scar Model for a comprehensive assessment through a double-blind, multicenter study. This approach minimized participant variability and accurately compared the treatment against a control, overcoming significant logistical challenges.
The study’s meticulous execution involved treating abdominoplasty patients with the peptide or control, with each participant serving as their own control to ensure data reliability. The informed consent process was rigorous, emphasizing ethical integrity. The outcome not only advances scar management knowledge but also validates the Northwestern Abdominoplasty Scar Model for future scar treatment research.
About the Client:
Our client was a US-based biotechnology company focused on the novel application of peptides for medical aesthetics and bone loss, collaborating with entities such as NASA.
The Challenge:
The client sought to explore a fibromodulin (FMOD)–based amino acid peptide sequence’s potential in reducing scar appearance and enhancing wound strength in humans, following promising preclinical results in pig models. The client aimed to gather comprehensive data, beyond mere cosmetic appearance to include functional outcomes such as tensile strength. The study’s complexity, necessitated by its intricate protocol and the significant surgical intervention of abdominoplasty, presented substantial logistical challenges.
The Solution:
ethica CRO adopted the Northwestern University Scar Model, a novel approach that allows for the evaluation of up to 20 cutaneous scars on a single research participant. This model facilitated the rigorous assessment of the injectable drug against a control, employing a double-blind, multicenter study design that ensured objective comparison and minimized research participant variability—a crucial factor in the complex nature of human wound healing.
Research participants undergoing abdominoplasty were meticulously mapped and treated with the investigational injectable or a control solution in designated areas, ensuring a balanced and controlled investigation. The study’s innovative design allowed each research participant to serve as their own control, enhancing the reliability of the findings. Follow-up timepoints varied, providing a rich dataset for evaluating the treatment’s efficacy over different stages of healing. Ensuring informed consent was critical in this study, emphasizing transparency about the study’s demands, risks, and the fact that opting out would leave participants with scars. This process was vital for participant understanding and ethical integrity within the framework of the Northwestern Abdominoplasty Scar Model.
The Results:
This research marked a significant step in understanding and improving scar management. The Northwestern Abdominoplasty Scar Model has proven invaluable, not only for this study but as a versatile tool for future research into scar therapeutics and wound healing processes.
ethica CRO’s strategic application of the Northwestern University Scar Model not only showcases its expertise in managing complex clinical trials but also its deep commitment to ethical research practices and advancing therapeutic interventions that deliver both aesthetic and functional benefits.