Seborrhoeic Eczema of the Scalp Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment