E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064131 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
intra indivudual (right-left comparison) |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
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Provided in protocol section 4.5 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |