A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel

Inclusion criteria

• Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
• Fitzpatrick skin types I-IV (due to lack of safety data for the investigational product in darker skin types);
• Complete a Medical Screening form as well as a Medical Personal History form;

Exclusion criteria

• Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
• Are not willing to refrain from using topical/systemic analgesics for 72 hours prior to and during the study (daily use of 81 mg aspirin is acceptable and occasional use of acetaminophen will be permitted);
• Are using systemic/topical corticosteroids for 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study;
• Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
• Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study;
• Have psoriasis and/or active atopic dermatitis/eczema;
• Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;