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) - Phase II SU Pilot Study

• Conditions: Solar Urticaria (SU); MedDRA version: 9.1Level: LLTClassification code 10041307Term: Solar urticaria

• Registration Number: EUCTR2007-001068-55-GB
• Lead Sponsor: Clinuvel Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Current Bowen’s disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.
--Female who is pregnant (confirmed by positive serum ß-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).
-Any factors that may affect skin reflectance measurements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether a CUV1647 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)).;Secondary Objective: - To evaluate the safety/tolerability of CUV1647 by measuring treatment-emergent adverse events.<br>- To determine the effect of CUV1647 on melanin density at several specified body sites.<br>- To evaluate a change in the MUD between Days 30 and 60.<br><br>;Primary end point(s): The primary efficacy endpoint of this study is the minimum urticarial dose. The primary efficacy analysis will compare the minimum urticarial dose at baseline and after CUV1647 treatment at Day 30 in each patient.