Clinical trial NCT01137331: K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seborrhoeic Eczema of the Scalp
Keywords: seborrhoeic eczema
scalp
dandruff
K301
K40
Lead sponsor: Moberg Pharma AB
Sponsor class: INDUSTRY
First posted: 2010-06-04
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male or female (including fertile women)
* 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:

* Seborrhoeic eczema or any other cutaneous disease of the face or scalp requiring a specific topical treatment (corticosteroids, antifungals, selenium sulphide, antibiotics, retinoids, benzoyl peroxide or a-hydroxyacids) during the previous 15 days
* 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

Primary outcomes:
measure: Erythema and desquamation scores
timeFrame: Week 4
Secondary outcomes:
measure: Erythema and desquamation scores
timeFrame: Week 2
measure: Erythema score
timeFrame: Weeks 2 and 4
measure: Desquamation score
timeFrame: Weeks 2 and 4
measure: Investigator's global evaluation
timeFrame: Week 4
measure: Patient's global evaluation
timeFrame: Week 4
measure: Pruritus/burning score
timeFrame: Weeks 2 and 4
measure: Dandruff score
timeFrame: Weeks 2 and 4
measure: Proportion of responders
timeFrame: Weeks 2 and 4
measure: Adverse events
timeFrame: Weeks 2, 4 and 5
Other outcomes:
Locations:
city: Farsta
country: Sweden
facility: Läkarhuset Farsta Centrum
city: Gothenburg
country: Sweden
facility: Centrumläkarna
city: Gothenburg
country: Sweden
facility: Kristinelundskliniken Hudläkarmottagningen
city: Gothenburg
country: Sweden
facility: Me3plus clinical trials
city: Gävle
country: Sweden
facility: Hedgrindhälsan AB
city: Helsingborg
country: Sweden
facility: Hudmottagningen
city: Hofors
country: Sweden
facility: Familjehälsan
city: Huddinge
country: Sweden
facility: Din doktor i Stockholm AB
city: Hägersten
country: Sweden
facility: Fruängens Läkarhus
city: Kristianstad
country: Sweden
facility: Capio Cityklinik
city: Limhamn
country: Sweden
facility: Limhamns Läkargrupp- Tärnan
city: Linköping
country: Sweden
facility: Hudläkarna i Linköping
city: Malmo
country: Sweden
facility: Center för Läkemedelsprövningar
city: Malmo
country: Sweden
facility: Hudkliniken UMAS
city: Malmo
country: Sweden
facility: Möllevångens Husläkargrupp
city: Trollhättan
country: Sweden
facility: Hjortens VC
city: Uddevalla
country: Sweden
facility: VC Silentzvägen Praktikertjänst
city: Uppsala
country: Sweden
facility: Hälsojouren
city: Uppsala
country: Sweden
facility: Läkarhuset Uppsala
Study officials:
affiliation: Hudkliniken UMAS
name: Åke Svensson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: