Seborrhoeic Eczema of the Scalp Clinical Trial
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
| Verified date | June 2010 |
| Source | Moberg Derma AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 201 |
| Est. completion date | April 2008 |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Läkarhuset Farsta Centrum | Farsta | |
| Sweden | Hedgrindhälsan AB | Gävle | |
| Sweden | Centrumläkarna | Gothenburg | |
| Sweden | Kristinelundskliniken Hudläkarmottagningen | Gothenburg | |
| Sweden | Me3plus clinical trials | Gothenburg | |
| Sweden | Fruängens Läkarhus | Hägersten | |
| Sweden | Hudmottagningen | Helsingborg | |
| Sweden | Familjehälsan | Hofors | |
| Sweden | Din doktor i Stockholm AB | Huddinge | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Moberg Derma AB |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Erythema and desquamation scores | The sum of erythema and desquamation scores at Week 4 | Week 4 | No |
| Secondary | Erythema and desquamation scores | The sum of erythema and desquamation scores at Week 2 | Week 2 | No |
| Secondary | Erythema score | Erythema score at Week 2 and 4 | Weeks 2 and 4 | No |
| Secondary | Desquamation score | Desquamation score at Week 2 and 4 | Weeks 2 and 4 | No |
| Secondary | Investigator's global evaluation | Investigator's global evaluation at Week 4 | Week 4 | No |
| Secondary | Patient's global evaluation | Patient's global evaluation at Week 4 | Week 4 | No |
| Secondary | Pruritus/burning score | Patient's pruritus/burning score at Week 2 and 4 | Weeks 2 and 4 | No |
| Secondary | Dandruff score | Patient's dandruff score at Week 2 and 4 | Weeks 2 and 4 | No |
| Secondary | Proportion of responders | Proportion of responders at Week 2 and 4 | Weeks 2 and 4 | No |
| Secondary | Adverse events | Adverse events classified by body system and preferred term | Weeks 2, 4 and 5 | Yes |