Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)

Last updated: June 5, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Hives (Urticaria)

Eczema (Atopic Dermatitis - Pediatric)

Allergies & Asthma

Treatment

Desloratadine 5 mg

Clinical Study ID

NCT01916980
4117-202
132245
  • Ages > 12
  • All Genders

Study Summary

This is an efficacy and safety study of up to 12 weeks of desloratadine in Japanese participants with eczema/dermatitis and dermal pruritus. The primary hypothesis of this study is that the sum of the daytime and nighttime pruritus/itch scores for both the eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week 2 compared to Baseline.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopicdermatitis, nummular eczema, seborrheic dermatitis, asteatotic eczema,neurodermatitis, etc. among eczema/dermatitis for which the observation of pruritusis appropriate)

  • Dermal pruritus (generalized dermal pruritus, localized dermal pruritus)

Exclusion

Exclusion Criteria:

  • Hypersensitivity to antihistamines or ingredients of a study drug

Study Design

Total Participants: 94
Treatment Group(s): 1
Primary Treatment: Desloratadine 5 mg
Phase: 3
Study Start date:
August 27, 2013
Estimated Completion Date:
March 22, 2014

Connect with a study center

  • MSD K.K.

    Chiyoda-Ku, Tokyo, 102-8667
    Japan

    Site Not Available

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