Project
Innovative Hyperhidrosis Therapy Using a Proprietary Cosmeceutical Containing Recombinant Neurotoxin
Tasks and Activities to be Implemented within the Project
The project aims to develop a cosmeceutical containing recombinant neurotoxins that, by disrupting the function of the Nav1.8 sodium channel on the surface of nerve cells in the skin, can reduce excessive sweating. This approach utilizes a biological mechanism (receptor blocking) to minimize perspiration, unlike the common physical mechanism used in deodorants (pore blockage).
The project includes the development of a sustainable and eco-friendly innovative production method for two recombinant neurotoxins, verification of their structure and properties, formulation of a cosmetic product ensuring the stability and activity of the neurotoxins, and validation of the cosmeceutical’s efficacy in a clinical study involving volunteers with hyperhidrosis.
The research will involve preparing prokaryotic expression systems carrying the desired gene sequences encoding the neurotoxins, obtaining a stable vector in a bacterial strain, optimizing culture conditions to maximize neurotoxin production efficiency, and scaling up recombinant neurotoxin production. Using E. coli strains enables a sustainable, efficient, and scalable approach to producing recombinant proteins – active ingredients in the cosmeceutical.
In the next phase, the correct structure of the neurotoxins will be confirmed using mass spectrometry, with particular emphasis on the proper formation of disulfide bonds. Their activity will be validated through the patch-clamp method in vitro using an oocyte model with overexpressed Nav1.8 sodium channels.
As part of the in vitro studies, following PN-EN ISO 10993-5:2009 standards for the biological evaluation of medical devices, the absence of cytotoxicity, irritation, and photoallergic properties will be confirmed using an artificial skin model. These studies will be conducted in line with the 7th Amendment to the EU Cosmetics Directive (76/768/EEC), REACH regulations, and EU Directive 2010/63/EU on animal protection. Additionally, the permeability of the neurotoxins will be assessed using model membranes simulating the epidermis, followed by testing their penetration through the human epidermis using skin samples.
Following this, application studies will be conducted with volunteers diagnosed with hyperhidrosis or excessive sweating beyond normal levels. The most effective application regimen for the cosmeceutical will be determined. The final product will have a significant, positive impact on psychological comfort and well-being, which are crucial for quality of life in today’s fast-paced world.
Target Groups
The target group for this project includes consumers seeking an effective, safe, and non-invasive cosmeceutical solution for hyperhidrosis, suitable for long-term use.
Project Objective
The project’s goal is to develop an effective cosmetic formulation containing recombinant neurotoxins for use in hyperhidrosis therapy.
Project Results
The project will result in the development of an innovative cosmeceutical using active neurotoxins for hyperhidrosis treatment. The product will be dermatologically safe and suitable for use on various skin areas with different sensitivities and thicknesses.
Project No.
FENG.01.01-IP.01-A09Z/24
Financing
The project is co-financed by the European Union through the European Funds for a Modern Economy 2021–2027 (FENG) program, National Centre for Research and Development grant program, Priority 1: Support for Entrepreneurs, Action: SMART Path.
Project Leader
Science4Beauty Sp. z o.o.
Project Partner
Warsaw University of Technology – Centre for Advanced Materials and Technologies (CEZAMAT)
Project Value
PLN 11,375,284.98
EU Funding Contribution
PLN 8,460,023.23