Skip to main content
OpenTrials
Completed

NCT Number: NCT01137331

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Seborrhoeic Eczema of the Scalp Dandruff Dermatitis Dermatitis, Seborrheic Scalp Dermatoses Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Läkarhuset Farsta Centrum, Färsta, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K301

Drug

Liquid- applied once daily prior to bed

Other names: K40

Placebo

Drug

Liquid- applied once daily prior to bed

Primary outcomes

  1. Erythema and desquamation scores

    Time frame: Week 4

    The sum of erythema and desquamation scores at Week 4

Secondary outcomes

  1. Erythema and desquamation scores

    Time frame: Week 2

    The sum of erythema and desquamation scores at Week 2

  2. Erythema score

    Time frame: Weeks 2 and 4

    Erythema score at Week 2 and 4

  3. Desquamation score

    Time frame: Weeks 2 and 4

    Desquamation score at Week 2 and 4

  4. Investigator's global evaluation

    Time frame: Week 4

    Investigator's global evaluation at Week 4

  5. Patient's global evaluation

    Time frame: Week 4

    Patient's global evaluation at Week 4

  6. Pruritus/burning score

    Time frame: Weeks 2 and 4

    Patient's pruritus/burning score at Week 2 and 4

  7. Dandruff score

    Time frame: Weeks 2 and 4

    Patient's dandruff score at Week 2 and 4

  8. Proportion of responders

    Time frame: Weeks 2 and 4

    Proportion of responders at Week 2 and 4

  9. Adverse events

    Time frame: Weeks 2, 4 and 5

    Adverse events classified by body system and preferred term

Sponsors and collaborators

Lead sponsor

Moberg Pharma AB

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2010
Registry last updated
Jun 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.