Clinuvel Pharmaceuticals (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) has revealed that a Phase II study of its drug implant SCENESSE® in Singapore has received the necessary regulatory and ethics committee approvals and commenced recruitment.
Sixty adults with vitiligo, a skin pigmentation disorder, will be recruited to the seven month, double-blind, placebo controlled study at the National Skin Centre, the leading dermatology hospital in Singapore.
The study will evaluate SCENESSE® as a combination treatment with narrowband ultraviolet B phototherapy.
Patients will be randomised into two treatment arms to receive either SCENESSE® or placebo implants every 28 days and will all be administered narrowband ultraviolet B phototherapy twice weekly.
The study aims to confirm results from an earlier, open label Phase IIa study of SCENESSE® in vitiligo, conducted in the U.S. which showed that the combination of SCENESSE® and light therapy provided greater and faster re-pigmentation in vitiligo patients compared to light monotherapy.
It will further evaluate SCENESSE® in vitiligo with a protocol tailored to patients with darker skin types, which have seen the most promising clinical results to date.
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