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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Seborrhoeic Eczema of the Scalp

Intervention / Treatment
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* Drug: K301
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K301<br>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. | Drug: K301<br>* Liquid- applied once daily prior to bed<br>* Other names: K40;|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* Liquid- applied once daily prior to bed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema and desquamation scores | The sum of erythema and desquamation scores at Week 4 | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema and desquamation scores | The sum of erythema and desquamation scores at Week 2 | Week 2 | 
| Erythema score | Erythema score at Week 2 and 4 | Weeks 2 and 4 | 
| Desquamation score | Desquamation score at Week 2 and 4 | Weeks 2 and 4 | 
| Investigator's global evaluation | Investigator's global evaluation at Week 4 | Week 4 | 
| Patient's global evaluation | Patient's global evaluation at Week 4 | Week 4 | 
| Pruritus/burning score | Patient's pruritus/burning score at Week 2 and 4 | Weeks 2 and 4 | 
| Dandruff score | Patient's dandruff score at Week 2 and 4 | Weeks 2 and 4 | 
| Proportion of responders | Proportion of responders at Week 2 and 4 | Weeks 2 and 4 | 
| Adverse events | Adverse events classified by body system and preferred term | Weeks 2, 4 and 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seborrhoeic eczema, scalp, dandruff, K301, K40