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

NCT ID: NCT01137630

Last Updated: 2010-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-05-31

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.

Conditions

Seborrhoeic Dermatitis of the Scalp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

K40a

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

K40b

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

K301a

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moberg Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Moberg Derma AB

Principal Investigators

Lennart Emtestam, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Dellenkliniken

Delsbo, , Sweden

Läkarhuset Farsta Centrum

Farsta, , Sweden

Stortorgets Hälsocentral

Gävle, , Sweden

Hedesunda Hälsocentral

Hedesunda, , Sweden

Familjehälsan

Hofors, , Sweden

Derbykliniken

Malmo, , Sweden

Möllevångens Läkargrupp,

Malmo, , Sweden

Möllevångens Läkargrupp

Malmo, , Sweden

Österpraktiken

Örebro, , Sweden

Department of Dermatology, Karolinska University Hospital

Stockholm, , Sweden

Hälsojouren

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

K40-3

Identifier Type: -

Identifier Source: org_study_id