Polymorphic Light Eruption (PLE)NCT00472901
Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)
An observational study of Polymorphic Light Eruption (PLE), run by Clinuvel Pharmaceuticals Limited at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Polymorphic Light Eruption (PLE)
- What is being tested?
- Afamelanotide (CUV1647)
- How many people
- 18 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2007to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate/severe polymorphic light eruption (PLE)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official 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).
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.
Read the detailed description
Polymorphic Light Eruption (PLE) is a prevalent photosensitivity disorder, occurring in up to 20% of the European and US populations and up to 5% of the Australian population. The disease is characterised by a rash that is intensely itchy with blisters, bumps and patches presenting on areas of the skin that have been exposed to the sun. There is a lack of effective treatment available for the condition but the most common available forms of therapy include sun avoidance and the use of the use of steroids and/or phototherapy.
- Conditions
- Polymorphic Light Eruption (PLE)
- Being tested
- Afamelanotide (CUV1647)
- Keywords
- Polymorphic Light Eruption (PLE), Afamelanotide, CUV1647, photoprotection, sun poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afamelanotide (CUV1647)Drug
16mg implant
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE
Measured: 18 months
Secondary outcomes (4)
To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting
Measured: 18 months
To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance
Measured: 18 months
To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymorphic Light Eruption (PLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lesley Rhodes, MD, Principal investigator, Hope Hospital, Manchester, United KingdomHerbert Hoenigsmann, MD, Principal investigator, Medical University of ViennaChris Baker, MD, Principal investigator, St. Vincent's Hospital, Melbourne, AUSTRALIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472901
- Sponsor's protocol ID
- CUV015
- Status last verified
- Oct 2011
- First submitted
- 10 May 2007
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT00472901
- Acronym / sponsor ID
- CUV015
- Conditions
- Polymorphic Light Eruption (PLE)
- Keywords
- Polymorphic Light Eruption (PLE), Afamelanotide, CUV1647, photoprotection, sun poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Clinuvel Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Polymorphic Light Eruption (PLE) is a prevalent photosensitivity disorder, occurring in up to 20% of the European and US populations and up to 5% of the Australian population. The disease is characterised by a rash that is intensely itchy with blisters, bumps and patches presenting on areas of the skin that have been exposed to the sun. There is a lack of effective treatment available for the condition but the most common available forms of therapy include sun avoidance and the use of the use of steroids and/or phototherapy.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate/severe polymorphic light eruption (PLE)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afamelanotide (CUV1647)16mg implant | Drug | – |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley Rhodes, MD principal investigator
Hope Hospital, Manchester, United Kingdom
Herbert Hoenigsmann, MD principal investigator
Medical University of Vienna
Chris Baker, MD principal investigator
St. Vincent's Hospital, Melbourne, AUSTRALIA
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymorphic Light Eruption (PLE), run by Clinuvel Pharmaceuticals Limited at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Austria, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.