Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema

• Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period [ Time Frame: Baseline and at endpoint during the 14 day treatment period ] [ Designated as safety issue: No ]
  The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion.
• Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period [ Time Frame: At endpoint during the 14 day treatment period ] [ Designated as safety issue: No ]
  Duration of pruritus was categorized as follows: 3 if > 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion.
• Global Improvement at Endpoint During the 14 Day Treatment Period [ Time Frame: At endpoint during the 14 day treatment period ] [ Designated as safety issue: No ]
  Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion.

• Change in the mean pruritus severity score
• Change in Duration of pruritus
• Change in Global Improvement Rate (GIR)

Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms

• Dermatitis
• Eczema

• Drug: Levocetirizine
  1 Levocetirizine 5mg tablet per day before bedtime for 14 days
  Other Name: Xyzal®
• Drug: Cetirizine
  1 Cetirizine 10mg tablet per day before bedtime for 14 days.
  Other Name: Zyrtec®
• Drug: Placebo-Levocetirizine
  1 Placebo-Levocetirizine tablet per day before bedtime for 14 days
• Drug: Placebo-Cetirizine
  1 Placebo-Cetirizine tablet per day before bedtime for 14 days
• Drug: Standard topical steroid (1% hydrocortisone) ointment
  1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

• Experimental: Levocetirizine
  Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
  Interventions:

  • Drug: Levocetirizine
  • Drug: Placebo-Cetirizine
  • Drug: Standard topical steroid (1% hydrocortisone) ointment
• Active Comparator: Cetirizine
  Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
  Interventions:

  • Drug: Cetirizine
  • Drug: Placebo-Levocetirizine
  • Drug: Standard topical steroid (1% hydrocortisone) ointment

Inclusion Criteria:

• Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus in the dermatitis and eczema
• Subjects who require and agree to the concomitant use of a topical steroid preparation.
• Subjects having a minimum level of pruritus and having used topical hydrocortisone during the run -in period
• Written informed consent signed and dated by subject/legal guardian
• Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method and have a negative pregnancy test.

Exclusion Criteria:

• Subjects with a known hypersensitivity to cetirizine or levocetirizine
• Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
• Have used forbidden concomitant medications or having not respected adequate wash-out periods as defined by the protocol