Phase II Solar Urticaria (SU) Pilot Study

NCT00859534 | Completed Phase 2

• 1 other identifier: CUV016
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Solar Urticaria

Keywords

Solar Urticaria

Outcome Measures

Primary Outcomes (1)

• To determine whether a CUV1647 (synthetic alpha-MSH analogue) bioresorbable implant can reduce the susceptibility of patients with Solar Urticaria to provocation with a standardized light source (measured as a change in minimum urticarial dose, (MUD)).

  60 days

Secondary Outcomes (3)

• To evaluate the safety/tolerability of CUV1647 by measuring treatment-emergent adverse events.

  60 days

• To determine the effect of CUV1647 on melanin density at several specified body sites.

  60 days

• To evaluate a change in the MUD between Days 30 and 60.

  60 days

Interventions

afamelanotide DRUG

16mg afamelanotide, one dose for the duration of the clincial trial

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

Study Sites (1)

Salford Royal Foundation Hospital (Hope Hospital)

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Urticaria, Solar

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Chronic Inducible Urticaria; Chronic Urticaria; Urticaria; Skin Diseases, Vascular; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lesley Rhodes, M.D.

  Salford Royal Foundation Hospital (Hope Hospital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 11, 2009
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

GB (1)