SkinBioTherapeutics begins human study on SkinBiotix

By Josh White

Date: Wednesday 19 Sep 2018

SkinBioTherapeutics begins human study on SkinBiotix

(Sharecast News) - Life science company SkinBioTherapeutics has commenced its human study being carried out on its 'SkinBiotix' technology, it announced on Wednesday.
The AIM-traded firm said there were three elements to the human study, with the first - already underway - aiming to assess skin irritancy.

It said the second, due to begin on 20 September, would assess moisturisation potential; and the third would assess the technology's impact on the barrier function.

That third element of the study, for which the company had now received final ethics approval, had been rescheduled to start in November due to capacity issues within the clinical research organisation.

SkinBioTherapeutics said study one was a skin irritancy test using different concentrations of SkinBiotix in the cream formulation.

Five different concentrations of the technology would be compared with the base formulation - that is, containing no SkinBiotix - and an existing marketed dermatological cream.

A total of 30 volunteers would be assessed for irritancy at various time points up to 72 hours, and the results were expected in October.

Study two would be an evaluation of the moisturisation potential of the SkinBiotix cream formulation compared to the base formulation.

That study would assess 20 participants, with an approximate 12-hour treatment period for each volunteer.

Those results were also expected in October.

The third study would be a test to determine whether the positive impact of the technology on the skin's barrier function, which had been demonstrated in laboratory studies, was replicated in human volunteers.

SkinBioTherapeutics said it had now received final ethics approval for the start of that study.

The study would be conducted with 120 female volunteers with self-assessed 'dry skin'.

It said the first 20 volunteers would be treated in November, with the remaining 100 volunteers treated in January.

Data on the first 20 volunteers was expected to be available in December, with the full read out on all 120 volunteers available during the first quarter of 2019.

"I am delighted that we now have all three aspects of our human study scheduled," said SkinBioTherapeutics chief executive officer Dr Cath O'Neill.

"Data from the two initial tests is expected in October 2018, and data from the third, larger test, is expected in the fourth quarter of 2018 and the first quarter of 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."


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