Polymorphic light eruption (PLE) MedDRA version: 9.1 Level: PT Classification code 10036087 Term: Polymorphic light eruption
Conditions
Interventions
Product Name: afamelanotide
Product Code: afamelanotide
Pharmaceutical Form: Implant
Pharmaceutical form of the placebo: Implant
Route o
Sponsors
Clinuvel Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Documented history of moderate/severe PLE as diagnosed/confirmed by a photodermatologist/photobiologist • Patients have recurrent episodes that occur at least once per year in their local environment 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
Exclusion criteria: • PLE requiring treatment with systemic immunosuppressive agents • Documented history of other photosensitivity conditions eg. Solar urticaria • Documented presence of anti nuclear antibody and/or positive extractable nuclear antibody • Evidence of clinically significant organ dysfunction or clinically significant deviation from normal in clinical or laboratory parameters • Females who are pregnant, lactating or of childbearing potential and not using adequate form(s) of contraception • Personal history of melanoma, lentigo maligma or multiple dysplastic nevi.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Evaluate whether afamelanotide prevents episodes or reduces the severity of symptoms in patients with PLE • Evaluate the safety and tolerability of afamelanotide • Evaluate the effect of afamelanotide on the use of rescue medication for the treatment of PLE symptoms • Evaluate the effect of afamelanotide on melanin density measured by skin reflectance ; Secondary Objective: • Determine whether afamelanotide has a beneficial effect on the quality of life of PLE sufferers • Determine if there are any confounding factors that may influence the severity of PLE symptoms ; Primary end point(s): • Physician’s global severity assessment and patient’s assessment at Days 60, 120 and 150. • Cumulative disease burden at Days 60, 120 and 150 in years 1 and 2. • Amount of rescue medication used • Changes in melanin density from baseline | — |
Countries
Austria, Belgium, Finland, France, Germany, United Kingdom
Outcome results
None listed