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    The EU Clinical Trials Register currently displays   35513   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-004074-93
    Sponsor's Protocol Code Number:EP005
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2004-004074-93
    A.3Full title of the trial
    A Pilot, Phase II, Open, Controlled Study to Evaluate the Safety, Tolerability and Efficacy of a Subcutaneous Implant of Melanotan in Patients Suffering from Recurrent Polymorphous Light Eruption.
    A.4.1Sponsor's protocol code numberEP005
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEpiTan Limited
    B.1.3.4CountryAustralia
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMelanotan
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[Nle4, D-Phe7]-α-melanocyte stimulating hormone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Polymorphous Light Eruption (PMLE)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To determine whether Melanotan implants given as a prophylactic can prevent or reduce the occurrence of symptoms like urticae, vesiculae, papulae, eczema, erythema and itching associated with Polymorphous Light Eruption (PMLE).
    E.2.2Secondary objectives of the trial
    •To establish the safety and tolerability [defined as absence of any toxicities > Grade 3 by WHO CTC as judged from observed Adverse Events] of a sustained release implant of Melanotan delivering approximately 20 mg over a 20-25 day period in Caucasian patients with a history of recurrent polymorphous Light Eruption (PMLE).
    •To compare the degree of tanning at 6 anatomic sites (determined by serial reflectance) at baseline and 10, 15 and 31 days after insertion of Melanotan.
    •To assess immunomodulatory effects of Melanotan.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The patients have to fulfil all of the following criteria for study participation:
    -Male or non-pregnant female Caucasian patients (skin types I to IV on the Fitzpatrick scale8)
    -Age 18 – 70 years
    -Weight < 90 Kg
    -Diagnosed PMLE-like syndrome
    -Written informed consent prior to the performance of any study-specific procedures
    E.4Principal exclusion criteria
    Any of the following criteria will exclude the patient from the study:
    - Personal history of melanoma, dysplastic nevus syndrome, an extraordinary number of moles or family history of melanoma in a first degree relative
    - Current Bowen’s disease, basal cell carcinoma, squamous cell carcinoma or other malignant skin lesions
    - Current pigmentary skin disorder e.g. vitiligo, melasma, haemochromatosis, mastocytosis, drug-induced pigmentation
    - Diagnosed with HIV/AIDS
    - Solarium and sunbathing, Photosensitizing medications and creams, or medications and creams that alter skin pigmentation. Examples include tetracycline antibiotics, amiodarone, chlorpromazine, hydroxychloroquine
    - Any evidence of clinically significant organ dysfunction, or any clinically significant deviation from normal in the clinical or laboratory determinations
    - No acute history of drug or alcohol abuse (at least 1 year)
    - History of disorders of the gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine (incl. Diabetes), neurological (incl. Seizures), haematological (especially anaemia) or systemic disease judged to be clinically significant
    - Major medical or psychiatric illness
    -Patient not suitable (e.g., noncompliance history) for the study in the opinion of the investigator
    -Female who is pregnant (confirmed by positive serum β-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)
    -Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints:

    Primary Endpoint
    -Incidence and severity of diagnosed outbreak of PMLE as determined by observation.

    Secondary Endpoints
    -Change in tanning from baseline (Day 17) to day 48 across 6 anatomic sites (forehead, left cheek, right inside upper arm, left medial forearm, right side of abdomen (avoiding implant insertion site), left side of sacral region/buttock) determined by skin luminance (L*) from skin reflectance (CIELAB standard observer response)
    -Change in tanning from baseline to day 48 across 6 anatomic sites (forehead, left cheek, right inside upper arm, left medial forearm, right side of abdomen (avoiding implant insertion site), left side of sacral region/buttock) determined by blue/yellow colour hue (b*-value) from skin reflectance measurements (CIELAB standard observer response)
    -Change in melanin density (MD) from baseline to day 48 across 6 anatomic sites (forehead, left cheek, right inside upper arm, left medial forearm, right side of abdomen (avoiding implant insertion site), left side of sacral region/buttock) determined by skin reflectance measurements (MD = 100 x (0.035307 + 0.009974(R420 – R400)), Dwyer et al10)
    -Change in erythema from Day -6 to day 33 on the sacral region/buttock determined by UV threshold testing
    -Change in tanning from Screening (Day –7) to day 32 on the sacral region/buttock determined by measurement of Immediate Pigment Darkening (IPD)
    -Change in in-vivo inflammatory activity from baseline to day 33 (optional additional sample at day 48) as measured by C-reactive protein determination in serum
    -Change in frequency of regulatory T-cells from baseline to day 33 (optional additional sample at day 48) as measured by FACS analysis of CD4+ /CD25+ T cells in PBMC.
    -Change in in-vitro immune cell function from baseline to day 33 (optional additional sample at day 48) as measured by in vitro LPS-stimulation of monocytes in ex vivo-derived PBMCs and in vitro anti-CD3/anti-CD28 stimulation of T cells in ex vivo-derived PBMCs.

    Safety Endpoints:

    -Incidence of any toxicities > Grade 3 as determined by WHO-CTC (as judged from observed Adverse Events)
    -Type and incidence of treatment-emergent adverse events
    -Physical examination changes from Screening (Day –7) to Day 48 (end-of-study)
    -Changes in blood pressure and heart rate
    -Changes in clinical chemistry, haematology and urinalysis parameters.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Untreated
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient, last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    N/A
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-09-01
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