Human study design and manufacturing scale-up for cosmetic application
- Human study: SkinBio provided the finalised design of its human study, which aims to test the efficacy of the cosmetic application of Skinbiotix®, the company’s proprietary probiotic platform.
- The study is planned to commence in Q3’18 and is expected to last eight weeks. The trial will be conducted by Alba Science an independent clinical research organisation (CRO) based in Edinburgh.
- The study aims to recruit 120 female volunteers presenting with self-assessed ‘dry-skin’. The volunteers will apply the cream formulation of SkinBiotix® three times a day with measurements taken regarding skin hydration, barrier-function and dryness. Skin samples will be taken at the beginning and end of the study to assess the effect of the technology on the skin microbiome.
- Manufacture: SkinBio has trialed a new method of scale-up with no detrimental impact on the activity of the SkinBiotix® platform. Further optimisation is required to meet the required commercial levels.
- Patents: The Company’s first patent (covering the use of bacteria and lysates in the treatment of skin in health and disease) which was granted in Australia in 2017, has been granted in New Zealand and Russia. Active prosecution is progressing in Europe, USA and China.
This announcement shows the Company is successfully continuing the progression of its cosmetic application. The cream formulation of SkinBiotix® recently passed effectiveness tests (RNS: April 17th ‘18) and is undergoing stability testing prior to use in the study. The study is expected to show that the SkinBiotix® cream will improve skin-hydration, strengthen barrier function and be safe for the skin microbiome. These are all characteristics of interest to partners for the development and commercialisation of a successful cosmetic product.
The Company has doubled the planned study sample size (originally 60 volunteers), which the Directors believe has marginal cost impact. The increase in sample size will strengthen the study data and if the trial is successful it will provide further impact in future partnering discussions.
SkinBio Therapeutics is a preclinical healthcare company focusing on skin health.