Clinuvel to start new vitiligo trial


By Dylan Bushell-Embling
Tuesday, 05 November, 2013

Clunuvel (ASX:CUV) has finalised preparations for a phase II Singapore trial of its Scenesse drug in vitiligo.

Pending regulatory and ethics approval, the trial will be conducted at the Pigment Clinic of Singapore’s National Skin Centre.

The centre aims to enrol around 60 patients in the study, split into a treatment and a placebo group. Both arms will also be administered narrowband ultraviolet B (NB-UVB) light therapy twice weekly - a standard vitiligo treatment.

Treatment efficacy will be assessed using validated tests for vitiligo repigmentation, time to onset of repigmentation and other measures including patient statements and their answers to quality-of-life questionnaires.

Recruitment is expected to take three months, and the stability of repigmentation achieved will be assessed after a three-month follow-up.

Via the study, Clinuvel hopes to confirm findings from a previous phase II trial suggesting that Scenesse and NB-UVB can provide faster and greater repigmentation than NB-UVB therapy alone.

The study will focus on darker-skinned patients, as data from the earlier trial indicate that Scenesse may be most effective in this cohort.

Clinuvel is also seeking approval for Scenesse as a treatment for rare light intolerance disorder erythropoietic protoporphyria (EPP).

Clinuvel (ASX:CUV) shares were trading 3.33% higher at $1.55 as of around 1.30 pm on Tuesday.

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