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

NCT01137630 | Completed Phase 2

• 1 other identifier: K40-3
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 11

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

Keywords

seborrhoeic dermatitis; scalp; K40a; K40b

Outcome Measures

Primary Outcomes (1)

• Erythema and desquamation scores

  Sum of erythema and desquamation scores at Week 4

  Week 4

Secondary Outcomes (13)

• Erythema and desquamation scores

  Weeks 2 and 8

• Responder

  Weeks 2, 4 and 8

• Erythema score

  Weeks 2, 4 and 8

• Desquamation score

  Weeks 2, 4 and 8

• Doctor's Global evaluation

  Week 4 and 8

Study Arms (3)

K40a

EXPERIMENTAL

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

K40b

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

K40a 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.

Also known as: K301a

K40a

K40b 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

Placebo 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (including fertile women)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moberg Pharma AB: lead

Study Sites (11)

Dellenkliniken

Delsbo, Sweden

Location

Läkarhuset Farsta Centrum

Farsta, Sweden

Location

Stortorgets Hälsocentral

Gävle, Sweden

Location

Hedesunda Hälsocentral

Hedesunda, Sweden

Location

Familjehälsan

Hofors, Sweden

Location

Derbykliniken

Malmo, Sweden

Location

Möllevångens Läkargrupp,

Malmo, Sweden

Location

Möllevångens Läkargrupp

Malmo, Sweden

Location

Österpraktiken

Örebro, Sweden

Location

Department of Dermatology, Karolinska University Hospital

Stockholm, Sweden

Location

Hälsojouren

Uppsala, Sweden

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Officials

• Lennart Emtestam, MD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 4, 2010
• Study Start: February 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: June 4, 2010

Record last verified: 2010-06

Locations

SE (11)