A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel
A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel
This is a randomized, single-center, controlled, within-subject comparison study assessing
 the sensitization potential of the investigational product, LEO 43204 gel under open
 conditions in healthy volunteers.

 LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of
 the back. Evaluation of dermal reactions at the application sites will be assessed clinically
 using a visual scale that rates the degree of erythema, edema and other signs of cutaneous
 irritation.

 Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will
 enter the Challenge Phase, which consists of one 48-hour application to a naive site on the
 opposite side of the back. Observations at the naive site during Challenge and the patterns
 of reactivity during the Induction Phase will provide a basis for an interpretation of
 contact sensitization.

 A total of 10 applications will be made over a period of approximately 6-8 weeks.
Inclusion Criteria:

 1. 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;

 2. Fitzpatrick skin types I-IV (due to lack of safety data for the investigational
 product in darker skin types);

 3. Complete a Medical Screening form as well as a Medical Personal History form;

 Exclusion Criteria:

 1. 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;

 2. 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);

 3. 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;

 4. Are using medication which, in the opinion of the investigative personnel, will
 interfere with the study results, including anti-inflammatory medications;

 5. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams,
 ointments, lotions, or similar products on the back during the study;

 6. Have psoriasis and/or active atopic dermatitis/eczema;

 7. 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;