Male and female subjects aged at least 30 years with a clinical diagnosis of photodamage (a score of at least 4 on the Griffiths photonumeric scale) and presence of mottled hyper-pigmentation on the face and meeting other specific inclusion/exclusion criteria MedDRA version: 9.0 Level: LLT Classification code 10064131
Conditions
Interventions
Trade Name: Metvix® 160 mg/g cream
Product Name: Metvix 160mg/g cream
Product Code: P 1202
Pharmaceutical Form: Cream
INN or Proposed INN: Methylaminolevulinate hydrochloride
CAS Number: 79416-27-6
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Sponsors
Galderma Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female subjects older than 30 years of age - Subjects with a photodamage graded at least 4 on the Griffiths photonumeric scale (symmetrical severity on the two target areas) - Subjects with mottled hyper-pigmentation on the face - Subject with Fitzpatrick phototypes I to IV - Female subjects of chidbearing potential with a negative urine pregnancy test at the baseline visit and who practices a highly effective method of contraception during the study - Female subjects of non-childbearing potential. They are not required to have a UPT at the beginning of the study 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: - Females who are pregnant, nursing or planning a pregnancy during the study - Subjects with a condition (e.g. eczema...), 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 suject's participation in the study. - Subjects with suspected of porphyria - Subjects with a wash-out period for topical treatment on the target treated areas less than : . Glycolic Acid, Salicylic acid, Lactic acid, other alpha hydroxy acids, other beta hydroxy acids : 2 weeks . Bleaching products : 2 weeks . UV light therapy, sunbathing and self-tanning products : 2 weeks . Topical retinoids (including retinol) : 4 weeks . PDT, laser, dermabrasion, peels : 3 months . Cosmetic procedures on the face such as botulinum toxin and fillers : 6 months - Subjects with a wash-out period for systemic treatment on the target treated areas less than : . Acitrein, etretinate, isotretinoin: 4 months - Subjects who foresee intensive UV exposure during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to compare the efficacy and safety of Metvix® PDT cream with that of its vehicle in photoaged skin. Three different application times will be studied : 1 hour, 2 hours and 3 hours;Secondary Objective: ;Primary end point(s): Week 20 | — |
Countries
United Kingdom
Outcome results
None listed