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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
98
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.
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.
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.
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
...and 1 more locations
Erythema and desquamation scores
Sum of erythema and desquamation scores at Week 4
Time frame: Week 4
Erythema and desquamation scores
Sum of erythema and desquamation scores at Week 2 and 8
Time frame: 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
Time frame: Weeks 2, 4 and 8
Erythema score
Erythema score at Week 2, 4 and 8
Time frame: Weeks 2, 4 and 8
Desquamation score
Desquamation score at Week 2, 4 and 8
Time frame: Weeks 2, 4 and 8
Doctor's Global evaluation
Doctor's Global evaluation at Week 4 and 8
Time frame: Week 4 and 8
Patient's Global evaluation
Patient's Global evaluation at Week 4 and 8
Time frame: Weeks 4 and 8
Pruritus score
Patient's pruritus score at Week 2, 4 and 8
Time frame: Weeks 2, 4 and 8
Dandruff score
Patient's dandruff score at Week 2, 4 and 8
Time frame: Weeks 2, 4 and 8
Dermatology Life Quality Index
Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8
Time frame: Week 4 and 8
Ease of application
Cosmetic properties; ease of application at Week 4 and 8
Time frame: Weeks 4 and 8
Stickiness
Cosmetic properties; stickiness at Week 4 and 8
Time frame: Weeks 4 and 8
Effect on hair quality
Cosmetic properties; effect on hair quality at Week 4 and 8
Time frame: Weeks 4 and 8
Adverse events
Adverse Events classified by body system and preferred term
Time frame: Weeks 0, 2, 4 and 8
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