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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
201
Liquid- applied once daily prior to bed
Liquid- applied once daily prior to bed
Läkarhuset Farsta Centrum
Farsta, Sweden
Hedgrindhälsan AB
Gävle, Sweden
Centrumläkarna
Gothenburg, Sweden
Kristinelundskliniken Hudläkarmottagningen
Gothenburg, Sweden
Me3plus clinical trials
Gothenburg, Sweden
Fruängens Läkarhus
Hägersten, Sweden
Hudmottagningen
Helsingborg, Sweden
Familjehälsan
Hofors, Sweden
Din doktor i Stockholm AB
Huddinge, Sweden
Capio Cityklinik
Kristianstad, Sweden
...and 9 more locations
Erythema and desquamation scores
The sum of erythema and desquamation scores at Week 4
Time frame: Week 4
Erythema and desquamation scores
The sum of erythema and desquamation scores at Week 2
Time frame: Week 2
Erythema score
Erythema score at Week 2 and 4
Time frame: Weeks 2 and 4
Desquamation score
Desquamation score at Week 2 and 4
Time frame: Weeks 2 and 4
Investigator's global evaluation
Investigator's global evaluation at Week 4
Time frame: Week 4
Patient's global evaluation
Patient's global evaluation at Week 4
Time frame: Week 4
Pruritus/burning score
Patient's pruritus/burning score at Week 2 and 4
Time frame: Weeks 2 and 4
Dandruff score
Patient's dandruff score at Week 2 and 4
Time frame: Weeks 2 and 4
Proportion of responders
Proportion of responders at Week 2 and 4
Time frame: Weeks 2 and 4
Adverse events
Adverse events classified by body system and preferred term
Time frame: Weeks 2, 4 and 5
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