Status:
COMPLETED
Assessment of the Phototoxic Potential of LEO 29102 Cream
Lead Sponsor:
LEO Pharma
Conditions:
Atopic Dermatitis
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00958516
Start Date
September 1 2009
End Date
October 1 2009
Last Update
February 24 2025
Active Locations (1)
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1
LEO Pharma investigational site
Saint-Quentin-en-Yvelines, France, 78054