Phase 3
Completed N=94
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)
Atopic Dermatitis · dermatitis · Dermal Pruritus
Source: ClinicalTrials.gov NCT01916980 ↗
Enrolled (actual)
94
Serious AEs
1.1%
Results posted
Nov 2014
Primary outcomePrimary: Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 — -1.63; -2.17 Score on a Scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 |
-1.63; -2.17 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event (AE) |
53.8; 48.3 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an AE |
6.2; 6.9 | — |
| SECONDARY Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 |
-0.83; -1.59; -1.29; -2.07; -1.88; -2.39 | — |
| SECONDARY Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 |
16.9; 34.5; 29.2; 51.7; 33.8; 51.7 | — |
| SECONDARY Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 |
-10.03; -21.90; -12.17; -24.72; -18.95; -28.45 | — |
Eligibility Criteria
Inclusion Criteria
- Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, seborrheic dermatitis, asteatotic eczema, neurodermatitis, etc. among eczema/dermatitis for which the observation of pruritus is appropriate)
- Dermal pruritus (generalized dermal pruritus, localized dermal pruritus)
Exclusion Criteria
- Hypersensitivity to antihistamines or ingredients of a study drug
Data sourced from ClinicalTrials.gov (NCT01916980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.