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

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.

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.

Study Overview

• Status: Completed
• Conditions: Seborrhoeic Dermatitis of the Scalp
• Intervention / Treatment: Drug: K40a; Drug: K40b; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Delsbo, Sweden
    • Dellenkliniken
  • Farsta, Sweden
    • Läkarhuset Farsta Centrum
  • Gävle, Sweden
    • Stortorgets Hälsocentral
  • Hedesunda, Sweden
    • Hedesunda Hälsocentral
  • Hofors, Sweden
    • Familjehälsan
  • Malmo, Sweden
    • Derbykliniken
  • Malmo, Sweden
    • Möllevångens Läkargrupp,
  • Malmo, Sweden
    • Möllevångens Läkargrupp
  • Stockholm, Sweden
    • Department of Dermatology, Karolinska University Hospital
  • Uppsala, Sweden
    • Hälsojouren
  • Örebro, Sweden
    • Österpraktiken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: K40a; 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.; Other Names: K301a
Experimental: 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.	Drug: K40b; 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.
Placebo Comparator: 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.	Drug: Placebo; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Moberg Pharma AB
• Investigators: Principal Investigator: Lennart Emtestam, MD, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: June 3, 2010
• First Submitted That Met QC Criteria: June 3, 2010
• First Posted (Estimate): June 4, 2010

Study Record Updates

• Last Update Posted (Estimate): June 4, 2010
• Last Update Submitted That Met QC Criteria: June 3, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: scalp; seborrhoeic dermatitis; K40a; K40b
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Dermatitis, Seborrheic
• Other Study ID Numbers: K40-3