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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-001068-55-GB |
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Date of registration:
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13/02/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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15/11/2007 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001068-55 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Solar Urticaria (SU)
MedDRA version: 9.1
Level: LLT
Classification code 10041307
Term: Solar urticaria
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Intervention(s)
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Product Name: CUV1647
Product Code: CUV1647
Pharmaceutical Form: Implant
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Primary Outcome(s)
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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.
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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)).
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Secondary Objective: - To evaluate the safety/tolerability of CUV1647 by measuring treatment-emergent adverse events.
- To determine the effect of CUV1647 on melanin density at several specified body sites.
- To evaluate a change in the MUD between Days 30 and 60.
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Secondary ID(s)
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CUV016
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N/A
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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