A Phase 3 interventional study of Desloratadine 5 mg in Eczema, Dermatitis and Dermal Pruritus, sponsored by Organon and Co. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
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.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 94 is above the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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)
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
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)
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
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
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
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
| Milestone | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus |
|---|---|---|
| Started | 65 | 29 |
| Completed | 58 | 25 |
| Not completed | 7 | 4 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Lack of efficacy | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Score on a Scale | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus |
|---|---|---|
| Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 | -1.63 (-2.01 to -1.25) | -2.17 (-2.74 to -1.61) |
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 | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus |
|---|---|---|
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | 53.8 | 48.3 |
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 | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus |
|---|---|---|
| Percentage of Participants Who Discontinued Study Drug Due to an AE | 6.2 | 6.9 |
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.
| Score on a Scale | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus |
|---|---|---|
| Change from Baseline at Day 3 (n=65, 29) | -0.83 (-1.18 to -0.49) | -1.59 (-2.10 to -1.07) |
| Change from Baseline at Week 1 (n=65, 29) | -1.29 (-1.66 to -0.92) | -2.07 (-2.62 to -1.52) |
| Change from Baseline at Week 4 (n=63, 28) | -1.88 (-2.29 to -1.47) | -2.39 (-3.01 to -1.78) |
| Change from Baseline at Week 6 (n=62, 26) | -2.33 (-2.72 to -1.94) | -2.48 (-3.07 to -1.89) |
| Change from Baseline at Week 8 (n=61, 25) | -2.18 (-2.59 to -1.76) | -3.15 (-3.79 to -2.52) |
| Change from Baseline at Week 12 (n=58, 25) | -2.51 (-2.89 to -2.14) | -3.47 (-4.04 to -2.90) |
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.
| Percentage of Participants | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus |
|---|---|---|
| Day 3 | 16.9 | 34.5 |
| Week 1 | 29.2 | 51.7 |
| Week 2 | 33.8 | 51.7 |
| Week 4 | 50.8 | 62.1 |
| Week 6 | 60.0 | 62.1 |
| Week 8 | 63.1 | 62.1 |
| Week 12 | 69.2 | 62.1 |
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.
| Score on a Scale | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus |
|---|---|---|
| Change from Baseline at Day 3 (n=65, 29) | -10.03 (-15.22 to -4.84) | -21.90 (-29.66 to -14.13) |
| Change from Baseline at Week 1 (n=65, 29) | -12.17 (-17.92 to -6.42) | -24.72 (-33.33 to -16.12) |
| Change from Baseline at Week 2 (n=63, 29) | -18.95 (-25.18 to -12.72) | -28.45 (-37.72 to -19.18) |
| Change from Baseline at Week 4 (n=63, 28) | -22.36 (-29.01 to -15.71) | -27.74 (-37.66 to -17.82) |
| Change from Baseline at Week 6 (n=62, 26) | -27.26 (-33.20 to -21.32) | -30.71 (-39.70 to -21.72) |
| Change from Baseline at Week 8 (n=61, 25) | -29.87 (-36.55 to -23.20) | -32.44 (-42.60 to -22.29) |
| Change from Baseline at Week 12 (n=58, 25) | -33.02 (-39.65 to -26.39) | -38.74 (-48.76 to -28.73) |
Collected over Up to 14 weeks (Up to 2 weeks after last dose of study drug). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Desloratadine: Eczema/Dermatitis | — | 1/65 (1.5%) | 16/65 (24.6%) |
| Desloratadine: Dermal Pruritus | — | 0/29 (0%) | 6/29 (20.7%) |
| Event | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus |
|---|---|---|
| Neoplasm skinNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/65 | 0/29 |
| Event | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus |
|---|---|---|
| NasopharyngitisInfections and infestations | 13/65 | 4/29 |
| Seborrhoeic dermatitisSkin and subcutaneous tissue disorders | 0/65 | 2/29 |
| SomnolenceNervous system disorders | 4/65 | 0/29 |
| Age, Continuous(Years) | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus | Total |
|---|---|---|---|
| Mean | 33.0 ± 15.2 | 44.1 ± 21.5 | 36.4 ± 18.0 |
| Sex: Female, Male(Participants) | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus | Total |
|---|---|---|---|
| Female | 34 | 17 | 51 |
| Male | 31 | 12 | 43 |
| Investigator-assessed Sum of Daytime and Nighttime Pruritus/Itch Scores at Baseline(Score on a Scale) | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus | Total |
|---|---|---|---|
| Mean | 4.75 ± 1.10 | 5.10 ± 1.47 | 4.86 ± 1.23 |
| Participant-assessed Pruritus Visual Analog Scale (VAS) Score at Baseline(Score on a Scale) | Desloratadine: Eczema/Dermatitis | Desloratadine: Dermal Pruritus | Total |
|---|---|---|---|
| Mean | 60.42 ± 18.94 | 60.79 ± 24.45 | 60.53 ± 20.66 |
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