Status:
COMPLETED
Phase II Solar Urticaria (SU) Pilot Study
Lead Sponsor:
Clinuvel Pharmaceuticals Limited
Conditions:
Solar Urticaria
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Male or female subjects with a diagnosis of solar urticaria (confirmed by phototesting) of sufficient severity that they have requested treatment to alleviate symptoms.
- React to provocation with a light source
- Aged 18-70 years
- Fitzpatrick Skin Type I- IV
- Written informed consent prior to the performance of any study-specific procedure.
Exclusion
- Allergy to CUV1647 or the polymer contained in the implant
- Any co-existent photodermatosis such as polymorphic light eruption (PLE), discoid lupus erythematosus (DLE) or erythropoietic porphyria (EPP).
- Personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi.
- Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.
- Diagnosed with HIV/AIDS or hepatitis.
- Any evidence of organ dysfunction or deviation from normal the clinical or laboratory determinations judged to be clinically significant by the Investigator.
- History of disorders of the gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine (including diabetes, Cushing's syndrome, Addison's disease, Peutz-Jeagher syndrome), neurological (including seizures), haematological (especially anaemia of less than 10 g/100 mL) or systemic disease judged to be clinically significant by the Investigator.
- Acute history of drug or alcohol abuse (in the last 12 months).
- Major medical or psychiatric illness.
- Patient assessed as not suitable for the study in the opinion of the investigator (e.g. noncompliance history, allergic to local anaesthetics, faints when given injections or giving blood).
- Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating.
- Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device).
- Sexually active men with partners of child bearing potential not using barrier contraception during the trial and for a period of three months hereafter.
- Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
- Any factors that may affect skin reflectance measurements.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00859534
Start Date
December 1 2008
End Date
July 1 2009
Last Update
September 15 2009
Active Locations (1)
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1
Salford Royal Foundation Hospital (Hope Hospital)
Manchester, United Kingdom