Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp

Study Overview
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Brief Summary
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Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales) disorder patterned on the sebum-rich areas of the scalp, face, and trunk. The current treatment does not cure the disease permanently. Therefore it must be repeated when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease, but are associated with a high frequency of relapse when treatment is stopped. They are reserved for acute flare-ups only as they may precipitate recurrences and dependence. In addition, chronic use of corticosteroids is associated with side-effects. The scientific rationale for the use of K40 for treatment of SD was based on clinical evidence that K40 improves erythema and desquamation with mild adverse reactions in a few cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and desquamation scores at Week 4.

Official Title
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A Multicenter, Randomised Double Blind, Placebo Controlled Study of Efficacy, Safety and Tolerability of Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp.

Conditions
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Seborrhoeic Dermatitis of the Scalp

Intervention / Treatment
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* Drug: K40a
* Drug: K40b
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female (including fertile women) 18-65 years of age Seborrhoeic dermatitis of the scalp for at least 2 months Presenting erythema and desquamation of mild, moderate, pronounced or severe intensity Signed written informed consent Exclusion Criteria: Patient on an antifungal, selenium sulphite or corticosteroid therapy within the last 2 weeks prior to start of study treatment Any other cutaneous disease of the face requiring a specific topical treatment (corticosteroids, antifungals, 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 SD associated with Parkinson's disease, human immunodeficiency virus infection Current or any history of ear, nose and throat carcinoma, Current or any history of severe concomitant disease according to Investigator'sjudgement Allergy to any of the tested treatment components

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: K40a<br>K40a is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. | Drug: K40a<br>* One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.<br>* Other names: K301a;|
| Experimental: K40b<br>K40b is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. | Drug: K40b<br>* One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.<br>|
| Placebo Comparator: Placebo<br>Placebo is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. | Drug: Placebo<br>* One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema and desquamation scores | Sum of erythema and desquamation scores at Week 2 and 8 | Weeks 2 and 8 | 
| Responder | Responder defined as a patient with complete remission (sum of erythema and desquamation scores=0) or partial remission (sum of scores=1 or 2) at Week 2, 4 and 8 | Weeks 2, 4 and 8 | 
| Erythema score | Erythema score at Week 2, 4 and 8 | Weeks 2, 4 and 8 | 
| Desquamation score | Desquamation score at Week 2, 4 and 8 | Weeks 2, 4 and 8 | 
| Doctor's Global evaluation | Doctor's Global evaluation at Week 4 and 8 | Week 4 and 8 | 
| Patient's Global evaluation | Patient's Global evaluation at Week 4 and 8 | Weeks 4 and 8 | 
| Pruritus score | Patient's pruritus score at Week 2, 4 and 8 | Weeks 2, 4 and 8 | 
| Dandruff score | Patient's dandruff score at Week 2, 4 and 8 | Weeks 2, 4 and 8 | 
| Dermatology Life Quality Index | Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8 | Week 4 and 8 | 
| Ease of application | Cosmetic properties; ease of application at Week 4 and 8 | Weeks 4 and 8 | 
| Stickiness | Cosmetic properties; stickiness at Week 4 and 8 | Weeks 4 and 8 | 
| Effect on hair quality | Cosmetic properties; effect on hair quality at Week 4 and 8 | Weeks 4 and 8 | 
| Adverse events | Adverse Events classified by body system and preferred term | Weeks 0, 2, 4 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seborrhoeic dermatitis, scalp, K40a, K40b