K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp
NCT ID: NCT01137331
Last Updated: 2010-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
201 participants
INTERVENTIONAL
2008-02-29
2008-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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K301
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.
K301
Liquid- applied once daily prior to bed
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.
Placebo
Liquid- applied once daily prior to bed
Interventions
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K301
Liquid- applied once daily prior to bed
Placebo
Liquid- applied once daily prior to bed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-70 years of age
* Seborrhoeic eczema of the scalp for at least 2 months
* Presenting erythema and desquamation of mild to moderate intensity
* Signed written informed consent
Exclusion Criteria
* Oral treatment with cyclines, lithium, antifungals or inhaled corticosteroids during the previous month
* Use of systemic corticosteroids and retinoids during the previous 2 months
* Seborrhoeic eczema associated with Parkinson's disease or HIV infection
* Current or any history of ear, nose, and throat carcinoma
* Current or any history of severe concomitant disease according to Investigator's judgement
* Allergy to any of the tested treatment components
* Subject who has been previously enrolled in the phase II study K40-3 investigating Kaprolac® K40
18 Years
70 Years
ALL
No
Sponsors
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Moberg Pharma AB
INDUSTRY
Responsible Party
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Moberg Derma AB
Principal Investigators
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Åke Svensson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hudkliniken UMAS
Locations
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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
Limhamns Läkargrupp- Tärnan
Limhamn, , Sweden
Hudläkarna i Linköping
Linköping, , Sweden
Center för Läkemedelsprövningar
Malmo, , Sweden
Hudkliniken UMAS
Malmo, , Sweden
Möllevångens Husläkargrupp
Malmo, , Sweden
Hjortens VC
Trollhättan, , Sweden
VC Silentzvägen Praktikertjänst
Uddevalla, , Sweden
Hälsojouren
Uppsala, , Sweden
Läkarhuset Uppsala
Uppsala, , Sweden
Countries
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Other Identifiers
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K301-I
Identifier Type: -
Identifier Source: org_study_id
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