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.

Conditions: seborrhoeic dermatitis of the scalp
MedDRA version: 9.1Level: LLTClassification code 10039794Term: Seborrhoeic dermatitis capitis

Registration Number: EUCTR2007-006188-59-SE

Lead Sponsor: Moberg Derma AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Male or female (including fertile women)
•18-70 years of age
•SE of the scalp for at least 2 months
•Presenting erythema and desquamation of mild to moderate intensity
•Signed written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•SE 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
•SE associated with Parkinson’s disease, human immunodeficiency virus (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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the efficacy of K301 compared to placebo after 4 weeks treatment in adults with Seborrhoeic Dermatitis of the scalp.<br><br>The primary efficacy variable is the sum of erythema and desquamation scores at week 4.;Secondary Objective: Secondary efficacy objectives are to evaluate the efficacy after 2 and 4 weeks of treatment with K301 compared to placebo and to assess safety and tolerability of K301 in adults with Seborrhoetic Dermatitis of the scalp.<br><br>The secondary efficacy variables are:<br>•Sum of erythema and desquamation scores at Week 2<br>•Erythema score at Week 2 and 4<br>•Desquamation score at Week 2 and 4<br>•Investigator’s Global evaluation at Week 4<br>•Patient’s Global evaluation at Week 4<br>•Patient’s pruritus/burning score at Week 2 and 4<br>•Patient’s dandruff score at Week 2 and 4<br>;Primary end point(s): The primary efficacy variable is the sum of erythema and desquamation scores at week 4.

Secondary Outcome Measures

Name	Time	Method

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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.

Recruitment & Eligibility

Study & Design

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