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

• Erythema and desquamation scores [ Time Frame: Weeks 2 and 8 ] [ Designated as safety issue: No ]
  Sum of erythema and desquamation scores at Week 2 and 8
• Responder [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
  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 [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
  Erythema score at Week 2, 4 and 8
• Desquamation score [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
  Desquamation score at Week 2, 4 and 8
• Doctor's Global evaluation [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
  Doctor's Global evaluation at Week 4 and 8
• Patient's Global evaluation [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
  Patient's Global evaluation at Week 4 and 8
• Pruritus score [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
  Patient's pruritus score at Week 2, 4 and 8
• Dandruff score [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
  Patient's dandruff score at Week 2, 4 and 8
• Dermatology Life Quality Index [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
  Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8
• Ease of application [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
  Cosmetic properties; ease of application at Week 4 and 8
• Stickiness [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
  Cosmetic properties; stickiness at Week 4 and 8
• Effect on hair quality [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
  Cosmetic properties; effect on hair quality at Week 4 and 8
• Adverse events [ Time Frame: Weeks 0, 2, 4 and 8 ] [ Designated as safety issue: Yes ]
  Adverse Events classified by body system and preferred term

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.

• 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 Name: K301a
• 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.

• 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.
  Intervention: Drug: K40a
• 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.
  Intervention: Drug: K40b
• 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.
  Intervention: Drug: Placebo

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