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

This study has been completed.
Sponsor:
Information provided by:
Moberg Derma AB
ClinicalTrials.gov Identifier:
NCT01137331
First received: June 3, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Seborrhoeic Eczema of the Scalp
Drug: K301
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Moberg Derma AB:

Primary Outcome Measures:
  • Erythema and desquamation scores [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The sum of erythema and desquamation scores at Week 4


Secondary Outcome Measures:
  • Erythema and desquamation scores [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The sum of erythema and desquamation scores at Week 2

  • Erythema score [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
    Erythema score at Week 2 and 4

  • Desquamation score [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
    Desquamation score at Week 2 and 4

  • Investigator's global evaluation [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Investigator's global evaluation at Week 4

  • Patient's global evaluation [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Patient's global evaluation at Week 4

  • Pruritus/burning score [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
    Patient's pruritus/burning score at Week 2 and 4

  • Dandruff score [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
    Patient's dandruff score at Week 2 and 4

  • Proportion of responders [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
    Proportion of responders at Week 2 and 4

  • Adverse events [ Time Frame: Weeks 2, 4 and 5 ] [ Designated as safety issue: Yes ]
    Adverse events classified by body system and preferred term


Enrollment: 201
Study Start Date: February 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137331

Locations
Sweden
Läkarhuset Farsta Centrum
Farsta, Sweden
Centrumläkarna
Gothenburg, Sweden
Kristinelundskliniken Hudläkarmottagningen
Gothenburg, Sweden
Me3plus clinical trials
Gothenburg, Sweden
Hedgrindhälsan AB
Gävle, Sweden
Hudmottagningen
Helsingborg, Sweden
Familjehälsan
Hofors, Sweden
Din doktor i Stockholm AB
Huddinge, Sweden
Fruängens Läkarhus
Hägersten, Sweden
Capio Cityklinik
Kristianstad, Sweden
Limhamns Läkargrupp- Tärnan
Limhamn, Sweden
Hudläkarna i Linköping
Linköping, Sweden
Center för Läkemedelsprövningar
Malmo, Sweden
Hudkliniken UMAS
Malmo, Sweden
Möllevångens Husläkargrupp
Malmo, Sweden
Hjortens VC
Trollhättan, Sweden
VC Silentzvägen Praktikertjänst
Uddevalla, Sweden
Hälsojouren
Uppsala, Sweden
Läkarhuset Uppsala
Uppsala, Sweden
Sponsors and Collaborators
Moberg Derma AB
Investigators
Principal Investigator: Åke Svensson, MD, PhD Hudkliniken UMAS
  More Information

No publications provided

Responsible Party: Kjell Rensfeldt MD, Moberg Derma AB
ClinicalTrials.gov Identifier: NCT01137331     History of Changes
Other Study ID Numbers: K301-I
Study First Received: June 3, 2010
Last Updated: June 3, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Moberg Derma AB:
seborrhoeic eczema
scalp
dandruff
K301
K40

Additional relevant MeSH terms:
Dermatitis, Seborrheic
Eczema
Dermatitis
Sebaceous Gland Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 20, 2014