Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)

NCTNCT00472901Other idCUV015

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Overview

Status: Completed
Phase: Phase not stated
Enrollment: 18 participants (actual)
Sponsor: Clinuvel Pharmaceuticals Limited · Industry
Design: Not stated
Countries: 3 countries
Australia, Austria, United Kingdom
Start: May 2007
Primary completion: Dec 2009
Completion: Sept 2010
First posted: 14 May 2007 (estimated)
Last update posted: 5 Oct 2011 (estimated)
Conditions: Polymorphic Light Eruption (PLE)

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20072008200920102011

Ph –
Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)
NCT00472901
May 2007 to Sept 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether the afamelanotide (CUV1647) formulation is effective in preventing PLE episodes or reducing the severity of PLE symptoms in patients with a well documented history of the disease. The study also aims to determine whether treatment with afamelanotide (CUV1647) can reduce the use of rescue medication in this group.

Interventions

Afamelanotide (CUV1647)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE
Time frame · 18 months

Secondary outcomes(4)

To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting
Time frame · 18 months
To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance
Time frame · 18 months
To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE
Time frame · 18 months
To determine if there are other factors that may influence the severity of PLE symptoms eg. sun exposure and use of sun protection methods
Time frame · 18 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Aged 18 - 70 years at inclusion. * Well documented history of moderate/severe PLE as diagnosed/confirmed by a photodermatologist or photobiologist. Newly diagnosed patients with moderate/severe PLE can be included if numbers of established patients are limited provided their diagnosis is confirmed by a photodermatologist or photobiologist. * Recurrent episodes that occur at least once a year, developing in own country (to exclude patients affected only when traveling to sunnier climates). * Have given written informed consent to participate in the study. Exclusion Criteria: * 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 skin lesions. * Documented history of other photosensitive conditions. * Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating. * Females of child-bearing potential that are not using adequate contraceptive measures.

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