K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp
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|ClinicalTrials.gov Identifier: NCT01137331|
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : June 4, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Seborrhoeic Eczema of the Scalp||Drug: K301 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
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.
Liquid- applied once daily prior to bed
Other Name: K40
Placebo Comparator: Placebo
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.
Liquid- applied once daily prior to bed
- Erythema and desquamation scores [ Time Frame: Week 4 ]The sum of erythema and desquamation scores at Week 4
- Erythema and desquamation scores [ Time Frame: Week 2 ]The sum of erythema and desquamation scores at Week 2
- Erythema score [ Time Frame: Weeks 2 and 4 ]Erythema score at Week 2 and 4
- Desquamation score [ Time Frame: Weeks 2 and 4 ]Desquamation score at Week 2 and 4
- Investigator's global evaluation [ Time Frame: Week 4 ]Investigator's global evaluation at Week 4
- Patient's global evaluation [ Time Frame: Week 4 ]Patient's global evaluation at Week 4
- Pruritus/burning score [ Time Frame: Weeks 2 and 4 ]Patient's pruritus/burning score at Week 2 and 4
- Dandruff score [ Time Frame: Weeks 2 and 4 ]Patient's dandruff score at Week 2 and 4
- Proportion of responders [ Time Frame: Weeks 2 and 4 ]Proportion of responders at Week 2 and 4
- Adverse events [ Time Frame: Weeks 2, 4 and 5 ]Adverse events classified by body system and preferred term
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137331
|Läkarhuset Farsta Centrum|
|Me3plus clinical trials|
|Din doktor i Stockholm AB|
|Limhamns Läkargrupp- Tärnan|
|Hudläkarna i Linköping|
|Center för Läkemedelsprövningar|
|VC Silentzvägen Praktikertjänst|
|Principal Investigator:||Åke Svensson, MD, PhD||Hudkliniken UMAS|