Seborrhoeic Eczema of the Scalp
Conditions
Keywords
seborrhoeic eczema, scalp, dandruff, K301, K40
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.
Interventions
DRUGK301
Liquid- applied once daily prior to bed
DRUGPlacebo
Liquid- applied once daily prior to bed
Sponsors
Moberg Pharma AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythema and desquamation scores | Week 4 | The sum of erythema and desquamation scores at Week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythema and desquamation scores | Week 2 | The sum of erythema and desquamation scores at Week 2 |
| Erythema score | Weeks 2 and 4 | Erythema score at Week 2 and 4 |
| Investigator's global evaluation | Week 4 | Investigator's global evaluation at Week 4 |
| Patient's global evaluation | Week 4 | Patient's global evaluation at Week 4 |
| Desquamation score | Weeks 2 and 4 | Desquamation score at Week 2 and 4 |
| Dandruff score | Weeks 2 and 4 | Patient's dandruff score at Week 2 and 4 |
| Proportion of responders | Weeks 2 and 4 | Proportion of responders at Week 2 and 4 |
| Adverse events | Weeks 2, 4 and 5 | Adverse events classified by body system and preferred term |
| Pruritus/burning score | Weeks 2 and 4 | Patient's pruritus/burning score at Week 2 and 4 |
Countries
Sweden
Outcome results
None listed