Clinical trial NCT00958516: Assessment of the Phototoxic Potential of LEO 29102 Cream
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: volunteers
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Phototoxic reaction according to the investigator's assessment
timeFrame: 5 days
Secondary outcomes:
measure: Clinical scoring and other skin reactions
timeFrame: 5 days
Other outcomes:
Locations:
city: St Quentin en Yvelines Cedex
country: France
facility: LEO Pharma investigational site
Study officials:
affiliation: LEO Pharma
name: Director International Clinical Development, MD
role: STUDY_DIRECTOR
References: