Trials assessing SCENESSE® (afamelanotide 16mg) in common photodermatosis
Clinical and regulatory progress:
- European and Australian Phase III trial (CUV015) preliminary results reported December 2009; see the announcement here
- Additional European Phase III trial (CUV032) commenced in Northern Hemisphere in spring of 2010
- Safety and efficacy shown in Phase II trials
- Program deferred
About Polymorphous Light Eruption
Polymorphous light eruption is a distressing seasonal skin condition with episodes most commonly beginning in spring and resolving by late-summer or autumn. Also known as polymorphic light eruption, PLE or PMLE, it is the most common photosensitivity and, after sunburn, is the most common sun-related problem seen by doctors. Symptoms include non-scarring, itchy or burning, red papules, vesicles or plaques and appears on sun-exposed skin 30 minutes to several hours following exposure to sunlight. Symptoms usually resolve over a period of a few days to a week or two.
PLE has a considerable impact on the quality of life for many people because of the need to avoid sun exposure during the spring and summer months. Learn more about polymorphous light eruption here.
Clinical results - PLE
Through clinical studies from 2005-2009, SCENESSE® (afamelanotide 16mg) has been shown that it may offer protection against, or reduce the severity of, outbreaks of PLE.
In December 2009, CLINUVEL released preliminary results from a Phase III study (CUV015) of SCENESSE® in patients diagnosed with PLE. For more information, see the company’s announcement.
- Ling TC, Gibbs NK, Rhodes LE. ‘Treatment of Polymorphic Light Eruption’. Photodermatol Photoimmunol Photomed 2003;19:217-27
- Tutrone WD, Spann CT, Scheinfeld N, Deleo VA. ‘Polymorphic Light Eruption’, Dermatologic Therapy 2003;16:28-9