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

Phase 2

Completed

• Conditions: Seborrhoeic Dermatitis of the Scalp
• Interventions: Drug: K40b; Drug: Placebo; Drug: K40a

• Registration Number: NCT01137630
• Lead Sponsor: Moberg Pharma AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2010-06
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Last Update Submitted: 2010-06-03
• Study First Posted: 2010-06-04
• Last Update Posted: 2010-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K40b	K40b	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.
Placebo	Placebo	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.
K40a	K40a	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.

Primary Outcome Measures

Name	Time	Method
Erythema and desquamation scores	Week 4	Sum of erythema and desquamation scores at Week 4

Secondary Outcome Measures

Name	Time	Method
Erythema and desquamation scores	Weeks 2 and 8	Sum of erythema and desquamation scores at Week 2 and 8
Responder	Weeks 2, 4 and 8	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
Erythema score	Weeks 2, 4 and 8	Erythema score at Week 2, 4 and 8
Desquamation score	Weeks 2, 4 and 8	Desquamation score at Week 2, 4 and 8
Doctor's Global evaluation	Week 4 and 8	Doctor's Global evaluation at Week 4 and 8
Patient's Global evaluation	Weeks 4 and 8	Patient's Global evaluation at Week 4 and 8
Pruritus score	Weeks 2, 4 and 8	Patient's pruritus score at Week 2, 4 and 8
Dandruff score	Weeks 2, 4 and 8	Patient's dandruff score at Week 2, 4 and 8
Dermatology Life Quality Index	Week 4 and 8	Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8
Ease of application	Weeks 4 and 8	Cosmetic properties; ease of application at Week 4 and 8
Stickiness	Weeks 4 and 8	Cosmetic properties; stickiness at Week 4 and 8
Effect on hair quality	Weeks 4 and 8	Cosmetic properties; effect on hair quality at Week 4 and 8
Adverse events	Weeks 0, 2, 4 and 8	Adverse Events classified by body system and preferred term

Trial Locations

Locations (11)

Hedesunda Hälsocentral; 🇸🇪 Hedesunda, Sweden

Stortorgets Hälsocentral; 🇸🇪 Gävle, Sweden

Derbykliniken; 🇸🇪 Malmo, Sweden

Möllevångens Läkargrupp,; 🇸🇪 Malmo, Sweden

Dellenkliniken; 🇸🇪 Delsbo, Sweden

Läkarhuset Farsta Centrum; 🇸🇪 Farsta, Sweden

Familjehälsan; 🇸🇪 Hofors, Sweden

Möllevångens Läkargrupp; 🇸🇪 Malmo, Sweden

Department of Dermatology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Österpraktiken; 🇸🇪 Örebro, Sweden

Hälsojouren; 🇸🇪 Uppsala, Sweden