Eczema, Dermatitis, Dermal Pruritus
Conditions
Keywords
Dermatitis, Dermatitis, Atopic, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases
Brief 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.
Interventions
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)
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 | Baseline Visit and Week 2 Visit | 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. |
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | Up to 14 weeks (Up to 2 weeks after last dose dose of study drug) | 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. |
| Percentage of Participants Who Discontinued Study Drug Due to an AE | Up to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | 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. |
| 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 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | 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. |
| 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 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desloratadine: Eczema/Dermatitis 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 anti-pruritic efficacy and there is no safety concern. | 65 |
| Desloratadine: Dermal Pruritus 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. | 29 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Lack of Efficacy | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Desloratadine: Dermal Pruritus | Total | Desloratadine: Eczema/Dermatitis |
|---|---|---|---|
| Age, Continuous | 44.1 Years STANDARD_DEVIATION 21.5 | 36.4 Years STANDARD_DEVIATION 18 | 33.0 Years STANDARD_DEVIATION 15.2 |
| Investigator-assessed Sum of Daytime and Nighttime Pruritus/Itch Scores at Baseline | 5.10 Score on a Scale STANDARD_DEVIATION 1.47 | 4.86 Score on a Scale STANDARD_DEVIATION 1.23 | 4.75 Score on a Scale STANDARD_DEVIATION 1.1 |
| Participant-assessed Pruritus Visual Analog Scale (VAS) Score at Baseline | 60.79 Score on a Scale STANDARD_DEVIATION 24.45 | 60.53 Score on a Scale STANDARD_DEVIATION 20.66 | 60.42 Score on a Scale STANDARD_DEVIATION 18.94 |
| Sex: Female, Male Female | 17 Participants | 51 Participants | 34 Participants |
| Sex: Female, Male Male | 12 Participants | 43 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 65 | 6 / 29 |
| serious Total, serious adverse events | 1 / 65 | 0 / 29 |
Outcome results
Primary
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.
Time frame: Baseline Visit and Week 2 Visit
Population: The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Desloratadine: Eczema/Dermatitis | Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 | -1.63 Score on a Scale |
| Desloratadine: Dermal Pruritus | Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 | -2.17 Score on a Scale |
Comparison: Analysis of the change from Baseline in least squares (LS) mean for the Desloratadine: Eczema/Dermatitis groupp-value: <0.001Longitudinal Data Analysis
Comparison: Analysis of the change from Baseline in LS mean for the Desloratadine: Dermal Pruritus groupp-value: <0.001Longitudinal Data Analysis
Primary
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.
Time frame: Up to 12 weeks
Population: The APaT population consisted of all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desloratadine: Eczema/Dermatitis | Percentage of Participants Who Discontinued Study Drug Due to an AE | 6.2 Percentage of Participants |
| Desloratadine: Dermal Pruritus | Percentage of Participants Who Discontinued Study Drug Due to an AE | 6.9 Percentage of Participants |
Primary
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.
Time frame: Up to 14 weeks (Up to 2 weeks after last dose dose of study drug)
Population: The All-Participants-as-Treated (APaT) population consisted of all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desloratadine: Eczema/Dermatitis | Percentage of Participants Who Experienced at Least One Adverse Event (AE) | 53.8 Percentage of Participants |
| Desloratadine: Dermal Pruritus | Percentage of Participants Who Experienced at Least One Adverse Event (AE) | 48.3 Percentage of Participants |
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
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.
Time frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit
Population: The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Day 3 (n=65, 29) | -0.83 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 1 (n=65, 29) | -1.29 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 4 (n=63, 28) | -1.88 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 6 (n=62, 26) | -2.33 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 8 (n=61, 25) | -2.18 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 12 (n=58, 25) | -2.51 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 8 (n=61, 25) | -3.15 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Day 3 (n=65, 29) | -1.59 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 6 (n=62, 26) | -2.48 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 1 (n=65, 29) | -2.07 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 12 (n=58, 25) | -3.47 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 4 (n=63, 28) | -2.39 Score on a Scale |
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
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.
Time frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit
Population: The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for participant-assessed pruritus/itch VAS score.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 2 (n=63, 29) | -18.95 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 6 (n=62, 26) | -27.26 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 1 (n=65, 29) | -12.17 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 8 (n=61, 25) | -29.87 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 4 (n=63, 28) | -22.36 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Week 12 (n=58, 25) | -33.02 Score on a Scale |
| Desloratadine: Eczema/Dermatitis | 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 | Change from Baseline at Day 3 (n=65, 29) | -10.03 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 12 (n=58, 25) | -38.74 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Day 3 (n=65, 29) | -21.90 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 1 (n=65, 29) | -24.72 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 2 (n=63, 29) | -28.45 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 4 (n=63, 28) | -27.74 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 6 (n=62, 26) | -30.71 Score on a Scale |
| Desloratadine: Dermal Pruritus | 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 | Change from Baseline at Week 8 (n=61, 25) | -32.44 Score on a Scale |
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
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.
Time frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit
Population: The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed Global Improvement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desloratadine: Eczema/Dermatitis | 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 | Week 2 | 33.8 Percentage of Participants |
| Desloratadine: Eczema/Dermatitis | 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 | Week 6 | 60.0 Percentage of Participants |
| Desloratadine: Eczema/Dermatitis | 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 | Week 1 | 29.2 Percentage of Participants |
| Desloratadine: Eczema/Dermatitis | 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 | Week 8 | 63.1 Percentage of Participants |
| Desloratadine: Eczema/Dermatitis | 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 | Week 4 | 50.8 Percentage of Participants |
| Desloratadine: Eczema/Dermatitis | 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 | Week 12 | 69.2 Percentage of Participants |
| Desloratadine: Eczema/Dermatitis | 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 | Day 3 | 16.9 Percentage of Participants |
| Desloratadine: Dermal Pruritus | 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 | Week 12 | 62.1 Percentage of Participants |
| Desloratadine: Dermal Pruritus | 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 | Day 3 | 34.5 Percentage of Participants |
| Desloratadine: Dermal Pruritus | 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 | Week 1 | 51.7 Percentage of Participants |
| Desloratadine: Dermal Pruritus | 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 | Week 2 | 51.7 Percentage of Participants |
| Desloratadine: Dermal Pruritus | 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 | Week 4 | 62.1 Percentage of Participants |
| Desloratadine: Dermal Pruritus | 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 | Week 6 | 62.1 Percentage of Participants |
| Desloratadine: Dermal Pruritus | 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 | Week 8 | 62.1 Percentage of Participants |