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

Primary Purpose

Seborrhoeic Eczema of the Scalp

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
K301
Placebo
Sponsored by
Moberg Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrhoeic Eczema of the Scalp focused on measuring seborrhoeic eczema, scalp, dandruff, K301, K40

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Läkarhuset Farsta Centrum
  • Centrumläkarna
  • Kristinelundskliniken Hudläkarmottagningen
  • Me3plus clinical trials
  • Hedgrindhälsan AB
  • Hudmottagningen
  • Familjehälsan
  • Din doktor i Stockholm AB
  • Fruängens Läkarhus
  • Capio Cityklinik
  • Limhamns Läkargrupp- Tärnan
  • Hudläkarna i Linköping
  • Center för Läkemedelsprövningar
  • Hudkliniken UMAS
  • Möllevångens Husläkargrupp
  • Hjortens VC
  • VC Silentzvägen Praktikertjänst
  • Hälsojouren
  • Läkarhuset Uppsala

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

K301

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Erythema and desquamation scores
The sum of erythema and desquamation scores at Week 4

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2010
Last Updated
June 3, 2010
Sponsor
Moberg Pharma AB
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1. Study Identification

Unique Protocol Identification Number
NCT01137331
Brief Title
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

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Moberg Pharma AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrhoeic Eczema of the Scalp
Keywords
seborrhoeic eczema, scalp, dandruff, K301, K40

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
K301
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
K301
Other Intervention Name(s)
K40
Intervention Description
Liquid- applied once daily prior to bed
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Liquid- applied once daily prior to bed
Primary Outcome Measure Information:
Title
Erythema and desquamation scores
Description
The sum of erythema and desquamation scores at Week 4
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Erythema and desquamation scores
Description
The sum of erythema and desquamation scores at Week 2
Time Frame
Week 2
Title
Erythema score
Description
Erythema score at Week 2 and 4
Time Frame
Weeks 2 and 4
Title
Desquamation score
Description
Desquamation score at Week 2 and 4
Time Frame
Weeks 2 and 4
Title
Investigator's global evaluation
Description
Investigator's global evaluation at Week 4
Time Frame
Week 4
Title
Patient's global evaluation
Description
Patient's global evaluation at Week 4
Time Frame
Week 4
Title
Pruritus/burning score
Description
Patient's pruritus/burning score at Week 2 and 4
Time Frame
Weeks 2 and 4
Title
Dandruff score
Description
Patient's dandruff score at Week 2 and 4
Time Frame
Weeks 2 and 4
Title
Proportion of responders
Description
Proportion of responders at Week 2 and 4
Time Frame
Weeks 2 and 4
Title
Adverse events
Description
Adverse events classified by body system and preferred term
Time Frame
Weeks 2, 4 and 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Åke Svensson, MD, PhD
Organizational Affiliation
Hudkliniken UMAS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Läkarhuset Farsta Centrum
City
Farsta
Country
Sweden
Facility Name
Centrumläkarna
City
Gothenburg
Country
Sweden
Facility Name
Kristinelundskliniken Hudläkarmottagningen
City
Gothenburg
Country
Sweden
Facility Name
Me3plus clinical trials
City
Gothenburg
Country
Sweden
Facility Name
Hedgrindhälsan AB
City
Gävle
Country
Sweden
Facility Name
Hudmottagningen
City
Helsingborg
Country
Sweden
Facility Name
Familjehälsan
City
Hofors
Country
Sweden
Facility Name
Din doktor i Stockholm AB
City
Huddinge
Country
Sweden
Facility Name
Fruängens Läkarhus
City
Hägersten
Country
Sweden
Facility Name
Capio Cityklinik
City
Kristianstad
Country
Sweden
Facility Name
Limhamns Läkargrupp- Tärnan
City
Limhamn
Country
Sweden
Facility Name
Hudläkarna i Linköping
City
Linköping
Country
Sweden
Facility Name
Center för Läkemedelsprövningar
City
Malmo
Country
Sweden
Facility Name
Hudkliniken UMAS
City
Malmo
Country
Sweden
Facility Name
Möllevångens Husläkargrupp
City
Malmo
Country
Sweden
Facility Name
Hjortens VC
City
Trollhättan
Country
Sweden
Facility Name
VC Silentzvägen Praktikertjänst
City
Uddevalla
Country
Sweden
Facility Name
Hälsojouren
City
Uppsala
Country
Sweden
Facility Name
Läkarhuset Uppsala
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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