Solar Urticaria Clinical Trial
Official title:
A Phase II, Open Label Pilot Study to Evaluate the Safety and Efficacy of A Bioresorbable Subcutaneous Implant of CUV1647 in Patients With Solar Urticaria (SU)
Urticaria is one of the most common dermatological conditions with diverse clinical
presentations and causes. Solar urticaria (SU) is a rare subset of physical urticaria, where
symptoms are induced by direct exposure of the skin to sunlight. As little as 5 minutes of
sun exposure can cause flares and whealing on exposed skin sites, accompanied by severe
itching. The wavelengths of radiation causing the eruption (i.e. the action spectrum) are in
the ultraviolet or visible light range. Initially described by Merklen in 1904, SU may have
a very sudden and dramatic onset, and then rapidly disappear once the exposure ceases. A
delayed form of SU has also been reported, although this is extremely rare. Information on
the pathophysiology of SU is limited and symptoms are confined to areas of the body exposed
to direct sunlight. The condition can be very distressing and severely impair the
individual's ability to go outdoors and to tolerate indoor lighting. The standard therapy,
i.e. oral antihistamines, is only partially effective and may provide little worthwhile
relief of symptoms.
This pilot study is proposed to evaluate implants containing 16mg CUV1647 as a prophylactic
treatment for patients with SU. The effectiveness of CUV1647 will be assessed by determining
the minimum urticarial dose before and after treatment.
When human skin is exposed to ultraviolet radiation from the sun or via the use of solaria,
it responds by increasing melanin levels within epidermal melanocytes. Ultraviolet light
enhances the local production and release of alpha-melanocyte stimulating hormone
(alpha-MSH), which results in increased melanin levels through a process known as
melanogenesis. Melanin, in the form of eumelanin, is a photoprotective agent. The mechanisms
proposed for photoprotection include, but are not limited to, the absorption and scattering
of UV and visible radiation, free radical scavenging and quenching of UV light. There is
also increasing evidence that melanogenesis represents a major antioxidant defence mechanism
in melanocytes, neutralising the deleterious effects of free radicals and active oxygen
species. Eumelanin acts as a neutral density filter and, unlike most sunscreens, reduces all
wavelengths of light equally so that the photoprotection provided by epidermal melanin
pigmentation is essentially independent of wavelength.
CUV1647 ([Nle4-D-Phe7]-alpha-MSH) is a potent and longer lasting analogue of alpha-MSH which
stimulates the production of eumelanin in the skin without the specific cell damage that
usually occurs when melanin production is stimulated by UV radiation.
Urticaria is one of the most common dermatological conditions with diverse clinical
presentations and causes. Solar urticaria (SU) is a rare subset of physical urticaria, where
symptoms are induced by direct exposure of the skin to sunlight. As little as 5 minutes of
sun exposure can cause flares and whealing on exposed skin sites, accompanied by severe
itching. The wavelengths of radiation causing the eruption (i.e. the action spectrum) are in
the ultraviolet or visible light range. Initially described by Merklen in 1904, SU may have
a very sudden and dramatic onset, and then rapidly disappear once the exposure ceases. A
delayed form of SU has also been reported, although this is extremely rare. Information on
the pathophysiology of SU is limited and symptoms are confined to areas of the body exposed
to direct sunlight. The condition can be very distressing and severely impair the
individual's ability to go outdoors and to tolerate indoor lighting. The standard therapy,
i.e. oral antihistamines, is only partially effective and may provide little worthwhile
relief of symptoms.
This pilot study is proposed to evaluate implants containing 16mg CUV1647 as a prophylactic
treatment for patients with SU. The effectiveness of CUV1647 will be assessed by determining
the minimum urticarial dose before and after treatment.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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