Assessment of the Phototoxic Potential of LEO 29102 Cream

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: LEO 29102 cream


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 29102 cream<br> | Drug: LEO 29102 cream<br>* LEO 29102 cream in different doses and the cream vehicle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phototoxic reaction according to the investigator's assessment |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical scoring and other skin reactions |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers