Trial Outcomes & Findings for An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201) (NCT NCT01916967)

NCT ID: NCT01916967

Last Updated: 2024-06-18

Results Overview

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 score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 239 participants
• Primary outcome timeframe: Baseline Visit and Week 2 Visit
• Results posted on: 2024-06-18

Participant Flow

Participant milestones

Measure	Desloratadine 5 mg Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Placebo Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
Overall Study STARTED	80	79	80
Overall Study COMPLETED	80	78	71
Overall Study NOT COMPLETED	0	1	9

Reasons for withdrawal

Measure	Desloratadine 5 mg Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Placebo Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
Overall Study Adverse Event	0	0	2
Overall Study Lack of Efficacy	0	0	6
Overall Study Physician Decision	0	0	1
Overall Study Protocol Violation	0	1	0

Baseline Characteristics

An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)

Baseline characteristics by cohort

Measure	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Placebo n=80 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Total n=239 Participants Total of all reporting groups
Age, Continuous	38.4 Years STANDARD_DEVIATION 16.3 • n=5 Participants	40.6 Years STANDARD_DEVIATION 15.8 • n=7 Participants	39.3 Years STANDARD_DEVIATION 15.2 • n=5 Participants	39.4 Years STANDARD_DEVIATION 15.7 • n=4 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	48 Participants n=7 Participants	45 Participants n=5 Participants	152 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	31 Participants n=7 Participants	35 Participants n=5 Participants	87 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline Visit and Week 2 Visit

Population: The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and a Week 2 assessment for this outcome measure.

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 score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.

Outcome measures

Measure	Placebo n=80 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2	-2.02 Score on a Scale Interval -2.4 to -1.65	-3.19 Score on a Scale Interval -3.56 to -2.83	-3.16 Score on a Scale Interval -3.52 to -2.79	—

PRIMARY outcome

Timeframe: Up to 4 weeks (Up to 2 weeks after last dose of study drug)

Population: The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.

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.

Outcome measures

Measure	Placebo n=79 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo n=1 Participants Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Number of Participants Who Experienced at Least One Adverse Event (AE)	16 Participants	24 Participants	18 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 2 weeks

Population: The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.

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.

Outcome measures

Measure	Placebo n=79 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo n=1 Participants Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Number of Participants Who Discontinued Study Drug Due to an AE	2 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline Visit and Day 3 Visit, Week 1 Visit

Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.

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 score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated.

Outcome measures

Measure	Placebo n=80 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 Change from Baseline at Day 3	-0.80 Score on a Scale Interval -1.14 to -0.46	-2.57 Score on a Scale Interval -2.91 to -2.23	-2.75 Score on a Scale Interval -3.09 to -2.41	—
Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 Change from Baseline at Week 1	-1.39 Score on a Scale Interval -1.72 to -1.06	-3.01 Score on a Scale Interval -3.34 to -2.68	-3.16 Score on a Scale Interval -3.5 to -2.83	—

SECONDARY outcome

Timeframe: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit

Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.

The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.

Outcome measures

Measure	Placebo n=80 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 Change from Baseline at Day 3	-0.61 Score on a Scale Interval -0.95 to -0.26	-2.62 Score on a Scale Interval -2.97 to -2.27	-2.72 Score on a Scale Interval -3.07 to -2.37	—
Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 Change from Baseline at Week 1	-1.38 Score on a Scale Interval -1.75 to -1.01	-2.98 Score on a Scale Interval -3.35 to -2.61	-3.13 Score on a Scale Interval -3.5 to -2.76	—
Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 Change from Baseline at Week 2	-1.91 Score on a Scale Interval -2.31 to -1.5	-3.17 Score on a Scale Interval -3.56 to -2.77	-3.21 Score on a Scale Interval -3.6 to -2.81	—

SECONDARY outcome

Timeframe: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit

Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.

The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.

Outcome measures

Measure	Placebo n=80 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 Change from Baseline at Day 3	-0.99 Score on a Scale Interval -1.31 to -0.67	-2.31 Score on a Scale Interval -2.63 to -2.0	-2.61 Score on a Scale Interval -2.93 to -2.29	—
Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 Change from Baseline at Week 1	-1.44 Score on a Scale Interval -1.76 to -1.12	-2.65 Score on a Scale Interval -2.97 to -2.33	-2.98 Score on a Scale Interval -3.3 to -2.66	—
Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 Change from Baseline at Week 2	-1.98 Score on a Scale Interval -2.33 to -1.64	-2.94 Score on a Scale Interval -3.28 to -2.61	-2.91 Score on a Scale Interval -3.25 to -2.57	—

SECONDARY outcome

Timeframe: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit

Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.

The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved.

Outcome measures

Measure	Placebo n=80 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 Day 3	15 Participants	54 Participants	55 Participants	—
Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 Week 1	32 Participants	54 Participants	58 Participants	—
Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 Week 2	38 Participants	59 Participants	53 Participants	—

SECONDARY outcome

Timeframe: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit

Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.

Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.

Outcome measures

Measure	Placebo n=80 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 Change from Baseline at Day 3	-0.50 Score on a Scale Interval -0.87 to -0.13	-2.37 Score on a Scale Interval -2.74 to -2.0	-2.73 Score on a Scale Interval -3.1 to -2.36	—
Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 Change from Baseline at Week 1	-1.27 Score on a Scale Interval -1.65 to -0.88	-2.53 Score on a Scale Interval -2.91 to -2.15	-2.85 Score on a Scale Interval -3.24 to -2.47	—
Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 Change from Baseline at Week 2	-1.75 Score on a Scale Interval -2.23 to -1.27	-2.85 Score on a Scale Interval -3.3 to -2.41	-2.97 Score on a Scale Interval -3.42 to -2.51	—

SECONDARY outcome

Timeframe: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit

Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.

Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated.

Outcome measures

Measure	Placebo n=80 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 Change from Baseline at Week 2	-25.24 Score on a Scale Interval -31.52 to -18.97	-45.86 Score on a Scale Interval -51.96 to -39.75	-45.01 Score on a Scale Interval -51.17 to -38.84	—
Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 Change from Baseline at Day 3	-5.22 Score on a Scale Interval -11.19 to 0.75	-35.94 Score on a Scale Interval -41.91 to -29.97	-39.60 Score on a Scale Interval -45.61 to -33.6	—
Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 Change from Baseline at Week 1	-15.88 Score on a Scale Interval -21.63 to -10.13	-40.82 Score on a Scale Interval -46.55 to -35.09	-48.82 Score on a Scale Interval -54.6 to -43.03	—

SECONDARY outcome

Timeframe: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit

Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.

Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.

Outcome measures

Measure	Placebo n=80 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=80 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 Change from Baseline at Day 3	-0.77 Score on a Scale Interval -1.13 to -0.4	-2.21 Score on a Scale Interval -2.57 to -1.85	-2.31 Score on a Scale Interval -2.67 to -1.94	—
Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 Change from Baseline at Week 1	-1.17 Score on a Scale Interval -1.52 to -0.83	-2.15 Score on a Scale Interval -2.5 to -1.81	-2.43 Score on a Scale Interval -2.77 to -2.08	—
Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 Change from Baseline at Week 2	-1.70 Score on a Scale Interval -2.11 to -1.29	-2.51 Score on a Scale Interval -2.88 to -2.13	-2.45 Score on a Scale Interval -2.83 to -2.06	—

SECONDARY outcome

Timeframe: Baseline Visit and Week 1 Visit, Week 2 Visit

Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for DLQI

The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants >=16 years of age completed the DLQI questionnaire about the condition of their skin over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated.

Outcome measures

Measure	Placebo n=77 Participants Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg n=79 Participants Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=77 Participants Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 Change from Baseline at Week 1	-1.60 Score on a Scale Interval -2.31 to -0.89	-3.82 Score on a Scale Interval -4.52 to -3.12	-4.08 Score on a Scale Interval -4.78 to -3.37	—
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 Change from Baseline at Week 2	-2.53 Score on a Scale Interval -3.28 to -1.78	-4.10 Score on a Scale Interval -4.83 to -3.38	-4.01 Score on a Scale Interval -4.74 to -3.28	—

Adverse Events

Desloratadine 5 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Desloratadine 10 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Desloratadine 5 mg→Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Desloratadine 5 mg n=80 participants at risk Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks	Desloratadine 10 mg n=79 participants at risk Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks	Placebo n=79 participants at risk Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks	Desloratadine 5 mg→Placebo n=1 participants at risk Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
Infections and infestations Nasopharyngitis	10.0% 8/80 • Number of events 8 • Up to 4 weeks (Up to 2 weeks after last dose of study drug) The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.	3.8% 3/79 • Number of events 3 • Up to 4 weeks (Up to 2 weeks after last dose of study drug) The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.	2.5% 2/79 • Number of events 2 • Up to 4 weeks (Up to 2 weeks after last dose of study drug) The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.	0.00% 0/1 • Up to 4 weeks (Up to 2 weeks after last dose of study drug) The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.
Nervous system disorders Somnolence	3.8% 3/80 • Number of events 3 • Up to 4 weeks (Up to 2 weeks after last dose of study drug) The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.	6.3% 5/79 • Number of events 6 • Up to 4 weeks (Up to 2 weeks after last dose of study drug) The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.	3.8% 3/79 • Number of events 3 • Up to 4 weeks (Up to 2 weeks after last dose of study drug) The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.	0.00% 0/1 • Up to 4 weeks (Up to 2 weeks after last dose of study drug) The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
• Publication restrictions are in place

Restriction type: OTHER