Clinical Trial Results

Phase III Clinical Results

Clinuvel has completed three Phase III clinical trials of SCENESSE® (afamelanotide). Erythropoietic protoporphyria (EPP) Erythropoietic protoporphyria (EPP) is a rare genetic disease found mainly in people with fair skin. It is characterised by severe phototoxicity (or intolerance to light) of the skin resulting in intolerable pain, swelling, and scarring, usually of the exposed areas such as the face, hands and feet. The pain experienced and expressed by EPP patients when their skin is exposed to light is reported as intolerable. EPP patients are often forced to remain indoors, severely affecting…

Phase II Clinical Results

Clinuvel has completed five Phase II clinical trials of SCENESSE® (afamelanotide) in four clinical indications – erythropoietic protoporphyria (EPP), polymorphous light eruption (PLE), solar urticaria (SU) and photodynamic therapy (PDT). These studies are summarised below: Erythropoietic protoporphyria (EPP) Erythropoietic protoporphyria (EPP) is a rare genetic disease found mainly in people with fair skin. It is characterised by severe phototoxicity (or intolerance to light) of the skin resulting in intolerable pain, swelling, and scarring, usually of the exposed areas such as the face, hands and feet. The pain experienced and expressed…

Phase I Clinical Results

Clinuvel has completed four Phase I, pharmacokinetic and pharmacodynamic trials of SCENESSE® (afamelanotide). These studies, conducted in 178 patients in Australia and the United States have been used to determine the early safety profile of afamelanotide in man as well as the optimal dose for the SCENESSE® implant as an effective photoprotective and repigmentary therapeutic.

SCENESSE® Spotlight

SCENESSE® as a repigmentation therapy

Clinuvel is currently conducting two clinical trials to evaluate the efficacy of SCENESSE® as a combination therapy with narrowband ultraviolet B (NB-UVB) phototherapy compared to NB-UVB alone. The goal of these trials is to determine whether SCENESSE® will reduce the total dose of radiation (NB-UVB) and the time required to reactivate skin pigment producing cells in ...