Assessment of the Phototoxic Potential of LEO 29102 Cream

A Phase 1 Study Evaluating the Phototoxic Potential of LEO 29102 Cream (2.5 mg/g, 1.0 mg/g, 0.3 mg/g, 0.1 mg/g, 0.03 mg/g) and the Cream Vehicle, Applied on Intact Skin of Healthy Male Subjects

The purpose of this trial is to evaluate the phototoxic potential of a single application on healthy skin of LEO 29102 cream in different doses.

Inclusion Criteria:

• Subjects having understood and signed an informed consent form
• Male adults between the age of 18 and 65 years (both inclusive)
• Healthy subjects without signs of skin irritation on test areas (erythema, dryness, roughness or scaling)
• Subjects willing and able to follow all the study procedures and complete the whole study
• Subjects affiliated to a social security system

Exclusion Criteria:

• Females
• Males who are not willing to use a local contraception for the entire duration of the study, and refrain from fathering a child within 3 months following the study drug
• Systemic treatments which may interfere with the inflammatory reaction (e.g., corticosteroids and other anti-inflammatory drugs) within 2 weeks prior to randomisation
• Systemic or topical treatments suspected of causing photobiological reactions (e.g., tetracycline, thiazides, fluoroquinolones) within 4 weeks prior to randomisation
• Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 4 weeks prior to inclusion or is planned during the study period
• Dark pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results (skin types V and VI on the Fitzpatrick scale)
• Scars, moles, sunburn or other blemishes in the test area which may interfere with grading
• Any systemic or cutaneous disease on the test area that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
• Relevant history of or concurrent photo-induced or photo-aggravated disease (abnormal response to sunlight
• Subjects with a history of serious allergy, allergic skin rash or known sensitivity to any component of the investigational products
• Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last four (4) weeks before randomisation
• Participation in any other current interventional clinical trial based on interview of the subject
• Previously randomised in this trial
• Subjects impossible to contact in case of emergency
• Subjects known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
• Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health
• Subjects under guardianship, hospitalised in a public or private institution for a reason other than research or subject deprived of freedom