K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

Phase 3

Completed

• Conditions: Seborrhoeic Eczema of the Scalp
• Interventions: Drug: Placebo; Drug: K301

• Registration Number: NCT01137331
• Lead Sponsor: Moberg Pharma AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2010-06
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Last Update Submitted: 2010-06-03
• Study First Posted: 2010-06-04
• Last Update Posted: 2010-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
K301	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.

Primary Outcome Measures

Name	Time	Method
Erythema and desquamation scores	Week 4	The sum of erythema and desquamation scores at Week 4

Secondary Outcome Measures

Name	Time	Method
Erythema and desquamation scores	Week 2	The sum of erythema and desquamation scores at Week 2
Erythema score	Weeks 2 and 4	Erythema score at Week 2 and 4
Desquamation score	Weeks 2 and 4	Desquamation score at Week 2 and 4
Investigator's global evaluation	Week 4	Investigator's global evaluation at Week 4
Patient's global evaluation	Week 4	Patient's global evaluation at Week 4
Pruritus/burning score	Weeks 2 and 4	Patient's pruritus/burning score at Week 2 and 4
Dandruff score	Weeks 2 and 4	Patient's dandruff score at Week 2 and 4
Proportion of responders	Weeks 2 and 4	Proportion of responders at Week 2 and 4
Adverse events	Weeks 2, 4 and 5	Adverse events classified by body system and preferred term

Trial Locations

Locations (19)

Fruängens Läkarhus; 🇸🇪 Hägersten, Sweden

Hudläkarna i Linköping; 🇸🇪 Linköping, Sweden

Möllevångens Husläkargrupp; 🇸🇪 Malmo, Sweden

Hudmottagningen; 🇸🇪 Helsingborg, Sweden

Centrumläkarna; 🇸🇪 Gothenburg, Sweden

Kristinelundskliniken Hudläkarmottagningen; 🇸🇪 Gothenburg, Sweden

Me3plus clinical trials; 🇸🇪 Gothenburg, Sweden

Läkarhuset Farsta Centrum; 🇸🇪 Farsta, Sweden

Din doktor i Stockholm AB; 🇸🇪 Huddinge, Sweden

Hedgrindhälsan AB; 🇸🇪 Gävle, Sweden

Capio Cityklinik; 🇸🇪 Kristianstad, Sweden

Familjehälsan; 🇸🇪 Hofors, Sweden

Center för Läkemedelsprövningar; 🇸🇪 Malmo, Sweden

Limhamns Läkargrupp- Tärnan; 🇸🇪 Limhamn, Sweden

Hudkliniken UMAS; 🇸🇪 Malmo, Sweden

VC Silentzvägen Praktikertjänst; 🇸🇪 Uddevalla, Sweden

Hälsojouren; 🇸🇪 Uppsala, Sweden

Hjortens VC; 🇸🇪 Trollhättan, Sweden

Läkarhuset Uppsala; 🇸🇪 Uppsala, Sweden