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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III, Multicenter, Open-Label Long-Term Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Eczema/Dermatitis and Dermal Pruritus.

Conditions
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Eczema, Dermatitis, Dermal Pruritus

Intervention / Treatment
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* Drug: Desloratadine 5 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desloratadine: Eczema/Dermatitis<br>Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient antipruritic efficacy and there is no safety concern. | Drug: Desloratadine 5 mg<br>* Desloratadine 5 mg/day: one 5-mg tablet taken orally once daily in the evening for up to 12 weeks (Desloratadine 10 mg/day: two 5-mg tablets taken orally once daily in the evening for up to 8 weeks)<br>|
| Experimental: Desloratadine: Dermal Puritus<br>Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern. | Drug: Desloratadine 5 mg<br>* Desloratadine 5 mg/day: one 5-mg tablet taken orally once daily in the evening for up to 12 weeks (Desloratadine 10 mg/day: two 5-mg tablets taken orally once daily in the evening for up to 8 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 | The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The change from Baseline in the sum of the daytime and nighttime pruritus/itch scores at Week 2 clinic visit was calculated. | Baseline Visit and Week 2 Visit | 
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE. | Up to 14 weeks (Up to 2 weeks after last dose dose of study drug) | 
| Percentage of Participants Who Discontinued Study Drug Due to an AE | An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE. | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime pruritus/itch scores at the Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated. | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | 
| 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 | The global improvement judgment criteria were used to assess overall improvement in pruritus/itch. The Investigator assessed the degree of severity of pruritus/itch based on 5 grades (1=Remarkably improved to 5=Aggravated) at Baseline and subsequent clinic visits. The percentages of participants who were remarkably improved (Grade 1=Pruritus/itch disappeared) or moderately improved (Grade 2=Pruritus/itch was greatly improved) at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated. | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | 
| 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 | Participants assessed the degree of their pruritus using a 100-mm visual analog scale (VAS; 0mm=No itch, 100mm=Worst imaginable itch) at Baseline and subsequent clinic visits. Pruritus/itch VAS scores could range from 0 to 100, with a higher score indicating more severe pruritus/itching. The changes from Baseline in the VAS scores for pruritus/itch at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated. | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatitis, Dermatitis, Atopic, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases