A Phase 3 interventional study of K301 and Placebo in Seborrhoeic Eczema of the Scalp, sponsored by Moberg Pharma AB. Completed at 19 sites in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-06-04.
Sponsored by Moberg Pharma AB · Phase 3, Interventional, and Treatment
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.
1,084 studies on the registry are indexed under Eczema; 137 are open to participants now.
This study's enrollment of 201 is above the median of 80 across 861 interventional studies indexed under Eczema.
Browse Eczema studies →Moberg Pharma AB is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
K301 applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning.
Drug: K301
Placebo applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning.
Drug: Placebo
Liquid- applied once daily prior to bed
Also known as: K40
Liquid- applied once daily prior to bed
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
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Moberg Pharma AB