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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00472901




Registration number
NCT00472901
Ethics application status
Date submitted
10/05/2007
Date registered
14/05/2007
Date last updated
5/10/2011

Titles & IDs
Public title
Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)
Scientific title
A Phase III, Randomised, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of CUV1647 in Patients Suffering From Polymorphic Light Eruption (PLE).
Secondary ID [1] 0 0
CUV015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polymorphic Light Eruption (PLE) 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Skin 0 0 0 0
Dermatological conditions
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Afamelanotide (CUV1647)

Treatment: Drugs: Afamelanotide (CUV1647)
16mg implant
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
To determine if there are other factors that may influence the severity of PLE symptoms eg. sun exposure and use of sun protection methods
Timepoint [4] 0 0
18 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 ß-HCG pregnancy test prior to
baseline) or lactating.

- Females of child-bearing potential that are not using adequate contraceptive measures.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincents Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Clinuvel Pharmaceuticals Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00472901
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lesley Rhodes, MD
Address 0 0
Hope Hospital, Manchester, United Kingdom
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00472901