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

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

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.

Study Overview

• Status: Completed
• Conditions: Seborrhoeic Eczema of the Scalp
• Intervention / Treatment: Drug: K301; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Farsta, Sweden
    • Läkarhuset Farsta Centrum
  • Gothenburg, Sweden
    • Centrumläkarna
  • Gothenburg, Sweden
    • Kristinelundskliniken Hudläkarmottagningen
  • Gothenburg, Sweden
    • ME3PLUS Clinical Trials
  • Gävle, Sweden
    • Hedgrindhälsan AB
  • Helsingborg, Sweden
    • Hudmottagningen
  • Hofors, Sweden
    • Familjehälsan
  • Huddinge, Sweden
    • Din doktor i Stockholm AB
  • Hägersten, Sweden
    • Fruängens Läkarhus
  • Kristianstad, Sweden
    • Capio Cityklinik
  • Limhamn, Sweden
    • Limhamns Läkargrupp- Tärnan
  • Linköping, Sweden
    • Hudläkarna i Linköping
  • Malmo, Sweden
    • Center för Läkemedelsprövningar
  • Malmo, Sweden
    • Hudkliniken UMAS
  • Malmo, Sweden
    • Möllevångens Husläkargrupp
  • Trollhättan, Sweden
    • Hjortens VC
  • Uddevalla, Sweden
    • VC Silentzvägen Praktikertjänst
  • Uppsala, Sweden
    • Hälsojouren
  • Uppsala, Sweden
    • Läkarhuset Uppsala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: K301; Liquid- applied once daily prior to bed; Other Names: 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.	Drug: Placebo; Liquid- applied once daily prior to bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythema and desquamation scores	The sum of erythema and desquamation scores at Week 4	Week 4

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Moberg Pharma AB
• Investigators: Principal Investigator: Åke Svensson, MD, PhD, Hudkliniken UMAS

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: June 3, 2010
• First Submitted That Met QC Criteria: June 3, 2010
• First Posted (Estimate): June 4, 2010

Study Record Updates

• Last Update Posted (Estimate): June 4, 2010
• Last Update Submitted That Met QC Criteria: June 3, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: scalp; seborrhoeic eczema; dandruff; K301; K40
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Dermatitis; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Eczema; Dermatitis, Seborrheic
• Other Study ID Numbers: K301-I