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

Organon

Status and phase: Completed; Phase 3

Conditions: Dermatitis; Eczema; Dermal Pruritus

Treatments: Drug: Desloratadine 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01916980

132245 (Registry Identifier)

4117-202

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Desloratadine: Eczema/Dermatitis

Experimental group

Description:

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.

Treatment:

Drug: Desloratadine 5 mg

Desloratadine: Dermal Puritus

Experimental group

Description:

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.

Treatment:

Drug: Desloratadine 5 mg