Polymorphous Light Eruption (PMLE)
Conditions
Interventions
Product Name: Melanotan
Pharmaceutical Form: Implant
INN or Proposed INN: [Nle4, D-Phe7]-a-melanocyte stimulating hormone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
EpiTan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 ß-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -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).;Secondary Objective: •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. ;Primary 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 ery | — |
Countries
Denmark, Finland
Outcome results
None listed