Patients with mild to moderate Actinic Keratoses on locations other than face and scalp. Classification code 10000614
Conditions
Interventions
Trade Name: Metvix 160 mg/g Creme
Product Name: Metvix 160mg/g Cream
Product Code: P-1202
Pharmaceutical Form: Cream
INN or Proposed INN: Methyl aminolevulinate hydrochloride(MAL)
CAS Number: 79416-27
Sponsors
Galderma R&D
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with clinical diagnosis of mild or moderate non hyperkeratotic Actinic Keratoses on the locations other than the face/scalp (including ears), 2. Subjects with AKs on locations other than the face/scalp with at least 4 comparable symmetrical and bilateral lesions (i.e. on the same body zone) (at least 2 lesions on each side of the body), of similar severity and similar number (no more than a twofold difference between the two sides), 3. Male or female subjects older than 18 years, 4. Negative pregnancy test for female Subjects at the beginning of the study, 5. Female of non childbearing potential, 6. Subjects able to follow study instructions and likely to complete all required visits, 7. Subjects sign the Informed Consent prior to any study procedures. 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: 1. Female subjects who are pregnant, nursing or planning a pregnancy during the study, 2. Subjects with a condition or who are in a situation which, in the Investigator’s opinion, may put the subject at risk, may confound the study results, or may interfere with the Subject’s participation in the study, 3. Subjects with known allergy to methyl aminolevulinate, to a similar compound or to any ingredient of the cream, 4. Subjects who have participated in another investigational drug or device research study within 30 days of enrolment, 5. Subjects with a wash-out period for topical treatment on the treated area (with 5-FU 3 months, cryotherapy 3 months, PDT 3 months, Diclofenac sodium 3 months, other less common AK treatments 3 months) 6. Subjects with more than 10 AK lesions on each treated zone, 7. Subjects with thick Actinic Keratosis lesions on the treated area, 8. Subjects with pigmented AK(s) on the treated areas 9. Subjects with suspected porphyria, 10. Subjects who are at risk in terms of precautions, warnings, and contra-indication in the package insert for Metvix®, 11. Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aim of this study is to compare the efficacy and safety of Metvix PDT cream with that of cryotherapy in subjects with Actinic Keratoses on locations other than the face and scalp, but the main purpose is to demonstrate non inferiority of Metvix PDT compared to cryotherapy in terms of lesion response at week 24.;Secondary Objective: The secondary efficacy variables are: · Lesion response rate at Week 12 visit · Subject complete response at Week 12 and Week 24 visits, will be only descriptively summarized · Cosmetic outcome assessed by the investigator at Week 12 and 24 visits, descriptively summarized for all Subjects combined (at the lesion level, for lesions in complete response) · Subject’s preference in term of cosmetic outcome at week 24 visit * Safety parameter: · Incidence of adverse event, descriptive analysis only * Other: · Subject’s questionnaire ;Primary end point(s): Only one primary efficacy variable is given which is the lesion response rate at Week 24 visit. | — |
Countries
Germany, United Kingdom
Outcome results
None listed