Clinical Trial: K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Moberg Pharma AB

Current Primary Outcome: Erythema and desquamation scores [ Time Frame: Week 4 ]

The sum of erythema and desquamation scores at Week 4


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Moberg Pharma AB

Dates:
Date Received: June 3, 2010
Date Started: February 2008
Date Completion:
Last Updated: June 3, 2010
Last Verified: June 2010