K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

Moberg Pharma

Status and phase: Completed; Phase 3

Conditions: Seborrhoeic Eczema of the Scalp

Treatments: Drug: K301; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01137331

K301-I

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 2 patient groups, including a placebo group

K301

Experimental group

Description:

K301 applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning.

Treatment:

Drug: K301

Placebo

Placebo Comparator group

Description:

Placebo applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning.

Treatment:

Drug: Placebo