SkinBioTherapeutics plc (LON:SBTX), a life science company focused on skin health, confirmed today that it has commenced its human study being carried out on its SkinBiotix® technology.
There are three elements to the human study: the first, already underway, is to assess skin irritancy; the second, due to commence on 20 September 2018, is to assess moisturisation potential; and the third is to assess the technology’s impact on the barrier function. This third element of the study, for which the Company has now received final ethics approval, has been rescheduled to commence in November due to capacity issues within the clinical research organisation.
Study one is a skin irritancy test using different concentrations of SkinBiotix® in the cream formulation. Five different concentrations of the technology will be compared with the base formulation (i.e. containing no SkinBiotix®) and an existing marketed dermatological cream. Thirty volunteers will be assessed for irritancy at various time points up to 72 hours. The results are expected in October 2018.
Study two is an evaluation of the moisturisation potential of the SkinBiotix® cream formulation compared to the base formulation. The study will assess 20 participants, with approximately a 12 hour treatment period for each volunteer. The results are expected in October 2018.
Study three is a test to determine whether the positive impact of the technology on the skin’s barrier function, which has been demonstrated in laboratory studies, is replicated in human volunteers. The Company has now received final ethics approval for the commencement of this study. The study will be conducted with 120 female volunteers with self-assessed ‘dry skin’. The first 20 volunteers will be treated in November 2018 with the remaining 100 volunteers treated in January 2019. Data on the first 20 volunteers is expected to be available in December 2018 with the full read out on all 120 volunteers available during Q1 2019.
Dr Cath O’Neill, CEO of SkinBioTherapeutics plc, commented:
“I am delighted that we now have all three aspects of our human study scheduled. Data from the two initial tests is expected in October 2018, and data from the third, larger test, is expected in Q4 2018 and Q1 2019. We hope that these results will provide additional proof of the SkinBiotix® technology’s efficacy and enable us to continue to pursue commercial discussions.”