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

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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.
• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.
• 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.

Primary Measures

• Erythema and desquamation scores
  • Time Frame: Week 4
    Safety Issue?: No

Secondary Measures

• Erythema and desquamation scores
  • Time Frame: Weeks 2 and 8
    Safety Issue?: No
• Responder
  • Time Frame: Weeks 2, 4 and 8
    Safety Issue?: No
• Erythema score
  • Time Frame: Weeks 2, 4 and 8
    Safety Issue?: No
• Desquamation score
  • Time Frame: Weeks 2, 4 and 8
    Safety Issue?: No
• Doctor's Global evaluation
  • Time Frame: Week 4 and 8
    Safety Issue?: No
• Patient's Global evaluation
  • Time Frame: Weeks 4 and 8
    Safety Issue?: No
• Pruritus score
  • Time Frame: Weeks 2, 4 and 8
    Safety Issue?: No
• Dandruff score
  • Time Frame: Weeks 2, 4 and 8
    Safety Issue?: No
• Dermatology Life Quality Index
  • Time Frame: Week 4 and 8
    Safety Issue?: No
• Ease of application
  • Time Frame: Weeks 4 and 8
    Safety Issue?: No
• Stickiness
  • Time Frame: Weeks 4 and 8
    Safety Issue?: No
• Effect on hair quality
  • Time Frame: Weeks 4 and 8
    Safety Issue?: No
• Adverse events
  • Time Frame: Weeks 0, 2, 4 and 8
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Moberg Derma AB Industry

Overall Clinical Trial Officials and Contacts

Lennart Emtestam, MD Principal Investigator Karolinska University Hospital  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01137630

Study ID Number: K40-3

ClinicalTrials.gov Identifier: NCT01137630

Health Authority: Sweden: Medical Products Agency