K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Seborrhoeic Eczema of the Scalp
Intervention
K301, Placebo
Location
Läkarhuset Farsta Centrum
Farsta
Sweden
Status
Completed
Source
Moberg Derma AB
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01137331
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:10-0400
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Medical and Biotech [MESH] Definitions
Scalp Dermatoses
Skin diseases involving the SCALP.
Tinea
A general term describing various dermatophytoses. Specific types include TINEA CAPITIS (ringworm of the scalp), TINEA FAVOSA (of scalp and skin), TINEA PEDIS (athlete's foot), and tinea unguium (see ONYCHOMYCOSIS, ringworm of the nails). (Dorland, 27th ed)
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Piedra
Either of two diseases resulting from fungal infection of the hair shafts. Black piedra occurs mainly in and on the hairs of the scalp and is caused by Piedraia hortae; white piedra occurs in and on the hairs of the scalp, beard, moustache and genital areas and is caused by Trichosporon beigelii.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
