NCT01137331

K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

A Multicenter, Randomised, Double Blind, Placebo-controlled Study of Efficacy, Safety, and Tolerability of Kaprolac® K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Moberg Pharma AB · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the head and trunk where sebaceous glands are most prominent. The severity varies from mild dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the mildest form of the disorder affects up to 15-20% of the population. In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE patients are treated once daily for 4 weeks. The population for this study is patients with mild to moderate SE. The primary endpoint for this study is the efficacy of K301 compared to placebo which was based on the sum score for erythema and desquamation after 4 weeks of daily application. Secondary endpoints are to evaluate safety and tolerability as well as efficacy.

Conditions

• Seborrhoeic Eczema of the Scalp

Interventions

Type	Name	Description
DRUG	K301	Liquid- applied once daily prior to bed
DRUG	Placebo	Liquid- applied once daily prior to bed

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2010-06-04
• Last updated: 2010-06-04

Locations

19 sites across 1 country: Sweden