Assessment of the Phototoxic Potential of LEO 29102 Cream (NCT00958516) | Clinical Trial Compass
CompletedPhase 1
Assessment of the Phototoxic Potential of LEO 29102 Cream
France32 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexMALE
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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, ps…
What they're measuring
1
Phototoxic reaction according to the investigator's assessment