Mild and/or moderate Actinic Keratoses MedDRA version: 14.1 Level: HLT Classification code 10020648 Term: Hyperkeratoses System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Metvix® 160 mg/g kräm
Product Name: Metvix® NDL
Product Code: CD 06809-41 NDL
Pharmaceutical Form: Cream
INN or Proposed INN: METHYL AMINOLEVULINATE HYDROCHLORIDE
CAS Number: 79416-27-6
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Sponsors
Galderma R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, who is at least 18 years of age or older, - Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas (TAs) according to Olsen et al scale (1991). (e.g.: thin and/or non-hyperkeratotic AKs), - Subject with two symmetrical TAs (either two half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs - TA comparable in terms of size: 6 by 16 cm at a maximum - A minimum of 5 AKs (either mild, moderate or both) per TA - No more than two lesions difference in number of moderate AKs between the two TAs. - Female of non-childbearing potential, OR female of childbearing potential with a negative urine pregnancy test (UPT). - If female of childbearing potential, they should: - have been strictly abstinent 1 month prior to Baseline and agrees to remain abstinent for the duration of the clinical trial, - and/or agree to use a highly effective and approved contraceptive method(s) during the duration of the clinical trial (bilateral tubal ligation OR combined oral contraceptives (oestrogens and progesterone) or implanted or injectable contraceptives with a stable dose for at least 1 month prior to Baseline OR vasectomized partner for at least 3 months prior to Baseline OR hormonal intra uterine device (IUD) inserted at least 1 month prior to Baseline. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - Subject with clinical diagnosis of at least one severe (Grade 3) AK on TAs according to Olsen et al (1991) scale (e.g. hyperkeratotic AKs), - Subject with pigmented AK on the TAs, - Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons; - Subject with porphyria, - Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs which, in the opinion of the investigator, might interfere with the interpretation of the clinical results, - Subject with systemic diseases that, in the opinion of the investigator might interfere with the interpretation of the clinical results, - History of hypersensitivity to nut products (e.g. peanut and almond oil) or soya, - Subject with a known past history of skin cancer in the TAs - Past history of skin melanoma - The Subject has received, applied or taken the following treatments or Procedures within the specified time frame prior to the Baseline visit: Topical treatment(s) on TAs: 5-Fluorouracil, diclofenac, imiquimod, retinoids, ingenol mebutat (Pep-005) : Duration 12 weeks Surgical: elliptical excision, excision and reconstructive surgery, Mohs’ micrographic surgery, chemical peels/chemosurgery, cryosurgery, dermabrasion: Duration 12 weeks PDT: Duration 12 weeks Laser: Duration 12 weeks Electrocoagulation: Duration 12 weeks Radiotherapy and UV radiation therapy: Duration 12 weeks Investigative therapies for Actinic Keratoses: Duration 12 weeks Alpha-hydroxy acid, salicylic acid ointment, urea: Duration 2 weeks Systemic treatment(s) Systemic retinoids: Duration 12 weeks Immunosuppressive drugs (such as glucocorticoids, cytostatic, antibodies, drugs acting on immunophilins, interferon, opioids , TNF binding proteins, Mycophenolate, small biologics agents):Duration 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary efficacy objective: To show the non-inferior efficacy of Metvix® Natural Day Light Photo Dynamic Therapy (NDL-PDT) versus Metvix® conventional Photo Dynamic Therapy (c-PDT) in Subjects with mild and moderate AKs at Week 12 in terms of percent reduction in lesions count. Primary safety objective: To compare the Subject’s self-assessment of pain of Metvix® NDL-PDT with that of Metvix® c-PDT. ;Secondary Objective: Not Applicable;Primary end point(s): Primary efficacy endpoint(s) The primary efficacy endpoint is the lesion complete response rate, defined as the percentage of pre-existing and treated lesions at baseline that were assessed as clear at Week 12. ;Timepoint(s) of evaluation of this end point: At week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoint(s) - Lesion complete response rate for mild lesions only. - Subject-side complete response rate defined as the percentage of subjects with all treated lesions clear in the corresponding TA, at Week 12. - change in lesion severity - number of new lesion Primary Safety endpoint - subject's self assessment of pain at baseline post-PDT procedures Secondary Safety endpoint - Incidence and severity of Adverse Events - skin aspect of lesion in complete response Other endpoint: weather and light asessment;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoint(s): at week 12 Safety primary endpoint: at Baseline post PDT-procedure Secondary safety endpoint: - adverse event: all along the study - skin aspect at week 12 | — |
Countries
Germany, Netherlands, Spain, Sweden
Contacts
Public ContactClinical Project Manager
Galderma R&D SNC
Outcome results
None listed