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

NCT01137331 | Completed Phase 3

• 1 other identifier: K301-I
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 19

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.

Conditions

Seborrhoeic Eczema of the Scalp

Keywords

seborrhoeic eczema; scalp; dandruff; K301; K40

Outcome Measures

Primary Outcomes (1)

• Erythema and desquamation scores

  The sum of erythema and desquamation scores at Week 4

  Week 4

Secondary Outcomes (9)

• Erythema and desquamation scores

  Week 2

• Erythema score

  Weeks 2 and 4

• Desquamation score

  Weeks 2 and 4

• Investigator's global evaluation

  Week 4

• Patient's global evaluation

  Week 4

Study Arms (2)

K301

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

K301 DRUG

Liquid- applied once daily prior to bed

Also known as: K40

K301

Placebo DRUG

Liquid- applied once daily prior to bed

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (including fertile women)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moberg Pharma AB: lead

Study Sites (19)

Läkarhuset Farsta Centrum

Farsta, Sweden

Location

Hedgrindhälsan AB

Gävle, Sweden

Location

Centrumläkarna

Gothenburg, Sweden

Location

Kristinelundskliniken Hudläkarmottagningen

Gothenburg, Sweden

Location

Me3plus clinical trials

Gothenburg, Sweden

Location

Fruängens Läkarhus

Hägersten, Sweden

Location

Hudmottagningen

Helsingborg, Sweden

Location

Familjehälsan

Hofors, Sweden

Location

Din doktor i Stockholm AB

Huddinge, Sweden

Location

Capio Cityklinik

Kristianstad, Sweden

Location

Limhamns Läkargrupp- Tärnan

Limhamn, Sweden

Location

Hudläkarna i Linköping

Linköping, Sweden

Location

Center för Läkemedelsprövningar

Malmo, Sweden

Location

Hudkliniken UMAS

Malmo, Sweden

Location

Möllevångens Husläkargrupp

Malmo, Sweden

Location

Hjortens VC

Trollhättan, Sweden

Location

VC Silentzvägen Praktikertjänst

Uddevalla, Sweden

Location

Hälsojouren

Uppsala, Sweden

Location

Läkarhuset Uppsala

Uppsala, Sweden

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic; Dandruff

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous; Scalp Dermatoses

Study Officials

• Åke Svensson, MD, PhD

  Hudkliniken UMAS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 4, 2010
• Study Start: February 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 4, 2010

Record last verified: 2010-06

Locations

SE (19)