Assessment of the Phototoxic Potential of LEO 29102 Cream

LEO Pharma

Status and phase

Completed

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: LEO 29102 cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT00958516

LEO 29102-C02

EudraCT Number 2009-011177-32

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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